March 6, 2025 • 46 mins
In this episode of Inside Cancer Careers, Dr. Shaalan Beg, Senior Advisor for Clinical Research at the NCI and Principal Investigator at Science 37, discusses the challenges and opportunities in the field of clinical trials. The conversation centers on the increasing number of potential cancer interventions and the need for efficient clinical trial infrastructure to test these interventions. Dr. Beg emphasizes the importance of matching patients to appropriate clinical trials and ensuring that the patient population in a trial is representative of the broader population with that specific disease. Dr. Beg shares his career path and share advice for those interested in a similar career.
SHOW NOTES:
Shaalan Beg, M.D., M.B.A.: https://www.linkedin.com/in/shaalanbeg/
Science 37: https://www.science37.com/science-37r-adds-acclaimed-researcher-and-oncologist-dr-shaalan-beg-bolster-therapeutic-depth
Virtual Clinical Trials Office: https://dctd.cancer.gov/MajorInitiatives/virtual_clinical_trials_office_pilot_program.htm
NCI Division of Cancer Treatment and Diagnosis (DCTD): https://dctd.cancer.gov/
AD: Worta McCaskill-Stevens Career Development Award for Community Oncology and Prevention Research (K12): https://www.cancer.gov/grants-training/training/funding/k12-mccaskill-stevens
Pancreatic Cancer Action Network (PanCan): https://pancan.org/
ASCO Leadership Development Program: https://www.asco.org/career-development/leadership-programs/leadership-development-program
American Society for Clinical Oncology: https://www.asco.org/
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Empire (podcast): https://podcasts.apple.com/ee/podcast/empire/id1639561921
300 Arguments by Sarah Manguso: https://www.graywolfpress.org/books/300-arguments
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
OLIVER BOGLER (00:04):
Hello and welcome to Inside Cancer Careers, a podcast from the National
Cancer Institute where we explore all the different ways people fight cancer
and hear their stories. I'm your host, Oliver Bogler from NCI's Center for Cancer Training.
Today, we're talking about the challenging issues surrounding clinical trials,
particularly how they can keep up with the very encouraging increase in new potential
(00:26):
clinical interventions being developed.Listen through to the end to hear our guest
make an interesting recommendation and where we invite you to take your turn. And of course,
we're always glad to get your feedback on what you hear and suggestions on what you might like
us to cover. The show's email is NCICC@nih.gov.Our guest today is Dr. Shaalan Beg, Senior Advisor
(00:48):
for Clinical Research at the NCI and a Principal Investigator at Science 37. Welcome, Dr. Beg.
SHAALAN BEG (00:55):
Thank you for having me. This is amazing.
OLIVER BOGLER (00:58):
So the increase in potential interventions for cancer,
while itself is good news, has led to a bottleneck at the clinical trial
stage. Sounds like a good problem to have, but still a problem, right?
SHAALAN BEG (01:10):
Yeah, we are in a situation where the scientific discoveries from
the lab are piling up and the clinical trial infrastructure is just not ready to test those
discoveries into the clinic in an efficient manner, which means that there's a backlog,
(01:34):
which means that innovative scientific approaches to help treat cancer are not
making their way into the clinic for clinical trials. And in oncology, where clinical trials
are largely considered part of standard of care, that means that in frequent situations,
(01:56):
that bottleneck is preventing access for standard of care for a lot of people with cancer.
OLIVER BOGLER (02:02):
So what are the main challenges
in the infrastructure that you see? How can they be overcome?
SHAALAN BEG (02:08):
I think about them in three different buckets. One is what are the
different hypotheses or observations from the lab or our non-clinical observations that we want
to study more formally in a prospective manner.The second is the infrastructure to operationalize
(02:29):
clinical trials in a manner which is compliant, in a manner which is ensuring
patient safety and high integrity data.And the third is having the ability to
have a workforce that can support this clinical infrastructure. And when I think about workforce,
(02:51):
I think about not just the postdocs and the students and the fellows and residents,
I also think about the development of our clinical research coordinators and data
specialists and administrators for the clinical trial infrastructure.
And then of course, principle investigators who are largely responsible for coming up
with innovative ideas, defining the strategy to translate those discoveries into the clinic and
(03:17):
then leading the entire initiative. And all of this comes before we even have the data
that's required to submit for regulatory purposes. You know, I don't think that
that's something that we can even talk about because the bottleneck is really much earlier.
OLIVER BOGLER (03:35):
So I'm a cancer survivor and I've had the privilege of participating in a couple
of clinical trials. So from a patient point of view, I sort of understand it,
right? You read a protocol, you read all the guidance and the cautions and then you sign it.
And then in my case, I had an immunotherapy to prevent the recurrence of my breast cancer. It
was a HER2 peptide immunization. But looking at it from the other side, from your side,
(04:00):
there's a lot to clinical trials. Can you sort of unpack for us a little bit, like,
okay, you are a clinician investigator, you have a great idea, and you're like,
I need to do a trial. What does the road ahead look like for you?
SHAALAN BEG (04:14):
As an investigator, the first thing that I think about when I see that
there's a new discovery that has potential applications at clinic is ‘does this match
the patients that I see in my clinic?’ Am I able to translate this discovery in a way that it can
make a short-term immediate-ish impact on the patients who come through my clinic?
(04:40):
The clinic that I largely participated in was focused on GI cancers and over
the years gravitated more to pancreas and biliary cancers. And so I would think about
those opportunities in a disease specific way and that allowed me to go deep into understanding the
(05:01):
various mechanisms that rule the disease of my interest and take it from there.
So there has to be a match between the hypothesis and the access for patients. I say that and it
seems like it's pretty obvious, but sometimes it isn't. And one of the most common reasons that
(05:23):
clinical trials are unsuccessful is that the clinical trial was not able to accrue patients
in a specified timeline to the extent that the science has moved on and the
trial may not have even completed enrollment.So that's first is ‘do I have the patients
that who can benefit from this clinical study?’ Second is really the, I guess that's also number
(05:48):
one is the science behind the proposal and is the rationale sound? Is there a clear logic in terms
of what allows me as a not a basic scientist to understand the potential mechanism on how
this intervention can modify the treatment?And is there a path to move that forward?
(06:13):
Something as simple as how is the drug going to be delivered? How is the treatment,
what medications can it be combined with? Do those fit in a clinical development paradigm,
which can be accepted into the clinic? And as a clinical investigator, we think a lot about how to
dovetail those new innovations into standard of care.
(06:36):
In diseases such as HER2 positive breast cancer, there are many existing treatments
that are out there that are effective for that disease. So a new discovery in that
space needs to be able to be a step above what is already available, or it needs to position
itself in a situation where the existing treatments have already been unsuccessful.
(07:00):
In a disease such as pancreatic cancer where there are not a lot of effective treatments, even the
approved treatments are modestly effective, the bar for our ability to be innovative and ask more
provocative questions in the clinic and expose our patients to such a hypothesis is sometimes lower
because both the people with cancer are looking for more innovative treatments. The standard
(07:25):
treatment is not something they're really excited and receiving either. And on the investigator
perspective, it's the same way. We want to be able to move those opportunities forward.
OLIVER BOGLER (07:35):
So you mentioned one critical element, and you mentioned several, but one was
having enough patients to accrue sufficient numbers to complete the trial. Obviously,
the rarer the tumor, the bigger that challenge is. So NCI and other groups
have built these networks, these cooperative groups, right, that allow clinical trials to
(07:55):
be simultaneously opened across multiple centers to sort of address that problem.
But it's not always effective. Even if you have a cooperative group,
I know from what I've heard from you and others that some trials just don't accrue. So is that
because they are not offering something that people want or what else is going on there?
SHAALAN BEG (08:15):
So we're a victim of our own success. As we start to understand cancer biology and what
drives cancers in people and how cancers are becoming resistant to approved treatments,
we have started to classify cancers into smaller and smaller subgroup. So people don't just
have breast cancer anymore. They now have ER positive or negative, PR positive or negative,
(08:39):
HER2 positive or negative breast cancer. You don't just have colon cancer, you now have BRAF
mutated or wild type, KRAS mutated or wild type, and then every type of KRAS varies as well. So as
we understand cancer and cancer biology better, we have started to split the diseases into more
(09:00):
restrictive buckets, which means that most cancers that we're doing studies on are rare tumors.
And there are not a lot of practices that see a critical mass of every one of those diseases where
they could significantly accrue a critical number of patients. That again leads into another aspect
(09:24):
which you and I have talked a lot about, which is the centers, let's say there's a center that
focuses on triple negative breast cancer or an investigator who focuses on triple negative breast
cancer, that investigator probably resides in an academic medical center in an urban environment.
So if you have a drug which is looking for triple negative breast cancer, you keep going to such
investigators who have built a reputation around triple negative breast cancer. They
(09:47):
may fill up your study, but then you may end up with a lot of urban patients who don't represent
the typical patient who has triple negative breast cancer because by large, most of those
patients are going to be seen in the community.So now when as a sponsor or when you're someone
who's running that clinical trial or thinking about accruing a clinical trial, you want the
(10:11):
patients who are going on that clinical trial to be representative of the patients who have
that disease. And you can't just accrue a large study which has regulatory intent with a handful
of sites. So then you start taking bets as an investigator. I don't know that's the correct term
(10:33):
to say take or not, but you open more sites that will be able to enroll more patients on clinical
trials and some of them will deliver, but a lot won't. And I think as a general rule, I think the
80-20 rule that applies to a lot of things in the world and in our daily lives also applies
(10:54):
here and 80 % of the enrollment takes place from 20 % of the sites. So you still end up with a lot
of sites that end up underperforming. When you're overseeing a network or you're an investigator or
you have a strict timeline and a strict budget, that can sometimes feel very unsustainable.
OLIVER BOGLER (11:12):
So the promise both of personalized medicine, right? We've heard of that buzzword now
for more than a decade. But what you're saying is that while it's a wonderful idea and concept,
it actually makes it very challenging to develop clinical trials that can test it effectively.
Plus, the unevenness in how the health care delivery system is built overall means
(11:34):
that not everybody can participate. Those sound like really significant challenges.
So you joined the NCI to take a look at some of these big challenges and tackle
them. And I know that you're also working with a group in the NCI's
Division of Cancer Treatment and Diagnosis, the Virtual Clinical Trials Office. Can you
tell us about the work that you're doing to try and take on some of these issues?
SHAALAN BEG (11:56):
Yeah, the Virtual Clinical Trials Office is the brainchild of Dr. Jim Doroshow at
DCTD and the NCI, who is looking to see how we can apply services centrally to help improve clinical
trial patient identification and screening at various sites. Related to the question that
(12:22):
you had before, all clinical trials have fairly restrictive inclusion and exclusion criteria.
Some trials are looking for left-handed unicorns is what one of my collaborators once mentioned.
And finding patients for those studies becomes challenging. And we know that patients and people
who have cancer are very likely to enroll on a clinical trial if they're only asked.
(12:49):
And if we can come up with ways to help increase that rate that that can then
lead to higher enrollments onto clinical trials. And sometimes the physicians who
are caring for those patients are not aware of the study, or they're not aware that the
patient who they have is eligible for that study. may not be front of mind,
(13:10):
and they may not know about the study at the right time of the patient's care.
So, what the virtual trials office is accomplishing is to use resources at NCI to
identify people and screen them for eligibility across various clinical sites to help support
(13:36):
NCI-funded clinical trials activity. And it's been successful in terms of understanding what
the nuances are for offering these services to the sites, contractual agreements,
communication with sites, making sure that there is sufficient on-site resources to then take over
once a patient has been enrolled. And that's one mechanism with which we can improve enrollment
(14:04):
on cancer clinical trials so that our trials don't last longer and that the sites are also
looking for additional resources so they can focus their staff's effort on people who are
highly probable to enroll in clinical trials and not end up not enrolling on the study.
These teams of nurses and coordinators are also supporting sites on activities such as adverse
(14:32):
event reporting and data cleanup. And this is a tremendous resource which we are learning to,
responding to what feedback we're getting from sites to help curate
the services that are available.There are other examples beyond
this experience as well of centers developing hub and spoke models to provide support to
(14:53):
less resourced clinical satellite or community clinical research centers. And it's important
for every site to be able to understand exactly what their needs are, what their PIs needs are,
what their site staff's needs are, and to be able to curate those services in a way that
takes the load off of the site themselves.And you can already imagine that as we learn
(15:15):
more about providing these services for patient identification and eligibility screening, that
can then be translated into other additional steps such as medication shipment to a patient's home,
adverse event collection at the patient's home using telemedicine for those resources. And
the NIH has had a few successful experiences in leading and supporting these studies during COVID.
(15:41):
And as we are thinking about factors such as interstate medical licensure, shipping medications
across state lines and how that varies between oral and IV medications, we're able to set up
the framework for us to use these novel mechanisms to make clinical trials more accessible so that
(16:02):
patients, people who have cancer, doctors who are caring for those folks who otherwise may not have
a supportive team to run clinical trials can have some additional support so that they can make
those trials available for their participants.The NCI benefits by being able to increase
access of their trials in the community, the sites and the doctors and patients who
(16:24):
get their care there benefit by being able to access those resources closer to home as well.
OLIVER BOGLER (16:31):
So you've mentioned telemedicine as one facilitator of this idea of the Virtual
Clinical Trials Office that also allows more people to participate. I wonder if you
also see opportunities, for example, I could imagine an AI sort of looking metaphorically
over the shoulder of the physician as they are treating a patient and saying something like,
(16:53):
this patient might have the characteristics that match this trial that's currently on offer. And
at the right time, as you said, sort of to give that that critical piece
of information. Is that the kind of future that we can look forward to?
SHAALAN BEG (17:07):
Yeah. The NCI is supporting the USCDI+ cancer initiative, which is looking
to structure EMR data elements within the electronic medical records and to optimize
that list to enable clinical trial matching. And that's precisely the vision that that initiative
has is how can we automate a lot of the patient characteristics for identifying
(17:34):
people for a clinical trial. When we go down the list of inclusion and exclusion criteria,
I'll give you an example. When it comes to age, demographics, or kidney function,
or even past medical history, those are probably easily, quote unquote, I'm air quoting here,
extractable from medical records. But when it comes to lines of therapy, that's one of
(17:58):
the very tricky inclusion criteria to automate because it requires the machine to be able to
interpret from the physician's note, what are the prior lines of therapy, recalibrate that into the
language which is present in the protocol and see if that matches or not. And even if you put five
oncologists in the room together and ask them to document a structured patient's prior treatments,
(18:24):
they're going to structure it 10 different ways.There is no standard and I don't think there
necessarily needs to be a standard, but there is no standard on documenting factors such as
lines of therapy. So there are elements around data residing in the electronic medical records
that is a barrier to us being able to create this trial matching AI bot in the background.
(18:50):
The second component for being able to match patients onto a clinical trial is actually the
way the data resides in the clinical trial protocols themselves. Surprise, surprise,
there are many different ways that the protocols are structured and there is very little agreement
(19:11):
in how inclusion exclusion criteria are even structured, which makes it hard to digitize
those criteria and be able to apply them.And there are initiatives, some supported
by the FDA even, that is encouraging the deployment of digital or structured protocols,
I should say, where the schedule of assessments and inclusion exclusion
(19:32):
criteria, dose modifications are all built in a harmonized way so that these tools can then
start to read the protocols in a way that they can then find the matched participant as well.
So there's a lot of work that's happening on both ends of this matching equation both in being able
to identify patients in a timely way using structured and unstructured data in electronic
(19:58):
medical records, and then on the other end, to be able to interpret clinical trial protocols.
And there are a lot of challenges, and the biggest challenge for both of these
is really is the way we've been doing it all the time leading up to here, because it does
require us to change behaviors which we have been very used to for decades and serve very
(20:20):
good purposes for a very long period of time. And then there is a process that needs to go in
terms of uptake and acceptance and optimization. And we are seeing stakeholders taking that on.
OLIVER BOGLER (20:34):
Sounds like an exciting time to be in this field. But I hear what you're saying.
You've got to change the culture alongside the technology and to really accomplish the goal.
I wanted to ask you about your role at Science 37. You served there as VP of oncology,
and you're still a principal investigator there,
if I'm correct. And you oversaw the decentralized clinical trial program there for oncology.
(21:00):
What was your experience in that group, and how has that helped you in your current role?
SHAALAN BEG (21:05):
Yeah. So decentralized clinical trials is a term that gained a lot of popularity
around the COVID pandemic. when a lot of clinical trial centers and offices were shut down, frankly,
or patients were not coming into the offices at the same rate. We then
(21:28):
realized that a lot of the components that are required to oversee someone's participation on
a clinical trial have already existed. Like there was FDA guidance in terms of decentralized trials.
There's some language out there even before COVID came about around the interpretation of Form 1572,
(21:50):
which is a regulatory document that the FDA uses.But we saw the demand for decentralized clinical
trial services surge during COVID. And when I use the phrase decentralized trials, I want to focus
on a couple of elements. We're talking about any clinical trial related procedure that takes place
(22:12):
at a location that is not the investigator's location. So it could be the patient's home,
it could be another doctor's office, it could be my colleague's office, just not my own office.
And when we talk about decentralized clinical trials, we don't necessarily need to think of
an entire clinical trial as being decentralized versus not. There are different elements within
(22:34):
the clinical trial. The physical exam is one element. The history is one element. Collecting
the vitals is an element. Getting imaging lab collections are all specific elements. And each
one of those could be done centrally at the PI's own office, which is the way we've been
doing clinical trials throughout, or they could be decentralized to where we can perform those
(22:59):
activities at site other than the investigator.What I just described to you right now is the
synthesis of lot of learnings that we went through over the last many years. And what's been very,
I've been very happy to see is that when we started to talk about decentralized
clinical trials, and this is a concept that's been around for a very long time,
but when we started to talk about this in the space of oncology, the initial reactions were,
(23:26):
that's never gonna work because in oncology, the drugs are too toxic and the patients are too sick
and how are we going to enable these studies?And what we found through varying experiences is
that for the right drug, with the right study question for the right patient population,
it does have a role. And when we surveyed large comprehensive cancer centers and asked
(23:52):
them about their use on decentralized trial elements, 100 % of their sites now say that
they have had experiences with some component of decentralized trials. That could be e-consent,
it could be telemedicine, it could be getting scans close to where the patients are. But it's
making its way into oncology, surely and steadily.During COVID, when study-related activity was
(24:15):
halted at lot of centers, there was a clinical trial which was structured in a way to administer
subcutaneous treatment for HER2-positive breast cancer at the participants' homes. So
patients were screened and identified at 12 large academic medical centers. After those patients
(24:38):
were enrolled, the entire care was done using a telemedicine platform with nurses going to the
patient's home, administering the medication, collecting blood samples, even doing a bedside
ejection fraction assessment for the heart.And this was a study with an intent to expand
regulatory labeling of the drug that was being studied. And the study ended up enrolling about
(25:04):
140 patients and 26 % of patients who enrolled on that study were Black, Hispanic or Asian.
Before the study, I would have said, you know, I don't know what the cultural acceptance even
of receiving cancer therapy at home is going to be. And what we've realized is again, you know,
we need to ask our patients on what their preferences are. These decentralized methods
(25:29):
have a significant advantage of reducing participant burden for a clinical trial.
The participant's child doesn't have to take off of work in order to drive their parent
to the office for study-related visits. And granted, we're not going to do liver biopsies
on the dining table or administer RT therapy in the living room. But especially when you look at
(25:54):
the new treatments that are coming in through the pipeline. We're looking at lot of sub-Q
medications. We're looking at oral medications, IM medications that have side effect profiles which
are conducive to administration at home. There are more trials that we can impact using these tools.
And why it's important for us to think about this in the clinical trial space is that we're seeing
(26:17):
standard of care administration evolving as well. The University of Pennsylvania and the Huntsman
Cancer Center in Salt Lake City have at-home programs for delivering their normal standard
of care cancer treatments at home. There's a list, the last time I checked, of 15 anti-cancer
treatments, infusions, that they have deemed safe to be given at home. That includes platinum drugs,
(26:42):
includes some new therapy medications. So essentially, medications that don't have a high
risk of infusion reactions can be done at home. So we need to keep an eye on how that is evolving
and make sure our trials are able to accommodate.So there are a lot of challenges in that space.
And I would say one of the major challenges is to provide sites and investigators
(27:06):
the right SOPs to be able to execute these clinical trials in a safe and compliant way.
At the end of the day, we want to make sure that our participants' safety was not compromised in
any way and the integrity of the data that we collected was not compromised in any way. And
(27:26):
depending on what element we're looking to decentralize for what type of study,
those two can line up very nicely, in which case we're seeing it move forward or not, in which case
we keep doing work the way we've had in the past.And the FDA came up with guidance which helped
address many of the concerns that sponsors and investigators have for being able to
(27:53):
operationalize these clinical trials. And now we're seeing those guidances percolate through
the societies and through the communities and sites are looking at it to see what their roles
may be. So I think the next few years are going to be very exciting as we see centers, again, learn
from NCI's virtual trial office experience and what's happening outside as well to operationalize
studies even within their own network.And I hope that cancer centers can completely
(28:20):
redefine what they consider is their catchment area. Because oftentimes, cancer centers will
feel that patients who walk through their doors are their patients. But now with these tools and
services that we have available, we are able to provide access for discoveries in our hospitals
(28:45):
and clinics and cancer centers into areas which otherwise would not have been accessible.
OLIVER BOGLER (28:51):
That sounds like phenomenally important work. Thank you. Thank you for doing
it. We're going to take a short break. And when we come back, we'll talk about careers.
[music]
Calling all senior oncologists committed to community oncology and reducing health
disparities! Are you passionate about shaping the next generation of researchers?
(29:14):
Apply to The Worta McCaskill-Stevens Career Development Award for Community Oncology and
Prevention Research (K12) program and mentor promising clinical scientists.
This unique NCI program supports the training of clinical scientists
in community cancer prevention, screening, intervention, control,
and treatment research. The program welcomes proposals for innovative research and career
(29:38):
development programs with an equity lens and a focus on increasing diversity in clinical trials.
As a program leader, you would guide clinical scientists from various oncology specialties as
they conduct research, potentially even leading their own independent clinical
trials. This is a chance to leverage your expertise and make a lasting impact
(29:58):
on cancer research and care in underserved communities.
For more information about the McCaskill-Stevens K12, including
how to apply and our staff contact details, visit our webpage – link is in the shownotes.
[music ends]
All right. We are back. I'm always curious on what got people
(30:22):
started in their path to medicine and science. What was that for you?
SHAALAN BEG (30:27):
You know, if you were to go back and read my personal statement for medical school,
it probably looked like a lot of others, right? In terms of wanting to go into medicine with the
desire to enter a profession where you get to help people day in and day out.
(30:48):
And as I started to go through my journey for medical school and residency and fellowship,
I was looking for a field which was in evolution, was evolving quickly, new discoveries moving into
the clinic that was exciting and growing and oncology checked a lot of those boxes.
(31:11):
I think my pursuit into the space of oncology, there are probably some overrepresented influence
by a few mentors and some patients who I've cared for over the years that shaped my thinking,
that made it clear for me on how I want to spend my time and go through the process. The
(31:34):
last many years have been absolutely amazing in terms of being able to have the privilege
to care for people who have cancer and work with scientists who have exciting discoveries
and want to move that into the clinic. And then from an operational perspective,
building programs where we can create change and do things in a way that helps people's lives.
OLIVER BOGLER (32:03):
I'm also curious about how you decided to take on this sort
of big challenge of overall of clinical trial. I don't know what the right word
is delivery clinical trial performance. It seems like everything right. You
already mentioned your specialty is in GI cancer and pancreatic cancer specifically,
I guess. But in addition to this very challenging clinical practice what made you think OK I also
(32:28):
want to work on this bigger problem of structural issues around clinical trials.
SHAALAN BEG (32:34):
I was the medical director for our clinical trials office at an NCI designated
cancer center at UT Southwestern in Dallas. And I started to appreciate the impact of operational
efficiencies, the importance of developing team members, helping them map out their careers,
(33:05):
the role of stakeholder engagement in being able to successfully pull off a
clinical trial or a clinical trial ecosystem.Then I think I got bit by the informatics bug
and really started to see the impact of electronic medical records and data that's
emanating from electronic medical records. Our ability to change how we generate evidence using
(33:29):
these tools. And for me, it's being able to be in a position where I can help take advantage
of the developments that are taking place around me. Like 10 years ago, it was electronic medical
records and it was harmonizing the data. And now we're seeing impacts on AI. And for me
(33:50):
being part of that change and maybe having a small part in defining the narrative and
how people talk about applying these tools in the oncology space was something which was important.
I also got annoyed when I would meet my friends and colleagues and we would talk about our
(34:12):
programs that we all were doing a reasonably good job about offering these services for patients who
walk through our doors. And I mentioned this earlier, but that we weren't doing enough for
people who couldn't walk through our doors. And that was really the driver for me to be able to
think differently because there was an opportunity to really grab these opportunities, these
(34:35):
developments, grab the bull by its horns and kind see what we can make with it.
And we're still very early in writing that chapter and there's a lot of work that needs to be done,
but I think the direction is clearly changing. And I can tell you that the direction is
changing because when I started to talk about decentralized clinical trials in oncology,
(34:56):
people said that's never going to happen. Oncology is too difficult. And now people are saying,
well, we've always been doing that anyway.I think there's a difference in how it's
being perceived, but there's still a long way to go. I don't think that that's just one tool
that we have. And I think you mentioned AI, what those applications are going to
(35:19):
look like. We have no idea how evidence generation is going to be in 10 years.
OLIVER BOGLER (35:24):
So you've also been involved in the Pancreatic Cancer Action Network,
and I wonder if you could tell us a little bit about that experience
and how that has influenced your approach to patient-centric research.
SHAALAN BEG (35:36):
So when I was a junior investigator trying to find my way in the scary world of
GI oncology, I had the privilege of working with a scientific basic science collaborator,
Dr. David Boothman, on work that he was doing around KRAS mutated cancers.
(35:57):
And that relationship led to a series of successful grant applications and
clinical trials that were funded and studies that we ran in Dallas as well.
And those were initially supported by the Pancreatic Cancer Action Network.
I credit them tremendously for supporting my early work and credit them for me being in the field and
(36:26):
having an interest in continuing to give back to the community. Every year, PanCan has a 5K where
we've had a team. And the first time we had a team, it was me and we didn't have a team,
we showed up to - Purple Stride is the name of the 5K - David Boothman and I showed up, we grabbed
(36:47):
a couple of lawn chairs and we had a poster that we grabbed from one of the booths when nobody was
looking and we wrote UT Southwestern and we tied them to those chairs and we just stood there and
started to see patients. And that evolved into us having a booth. It grew to our team to now, know,
the UT Southwestern has three teams and raised a lot of money and, you know, is a force over there.
(37:11):
And again, it's not just the folks at PanCAN, but also the community that PanCAN had built around
pancreatic cancer was my tribe or is my tribe. That's where I found my mentors. That's where I
found my colleagues where peer mentorship is a thing. Talking to folks who are grappling with
similar challenges that I may be at that phase of my career and PanCAN provided that community,
(37:36):
they provided those resources and that mission and they'll always have that space in my heart.
So still have my Pan Can pin on my blazer if you see me at oncology conferences.
OLIVER BOGLER (37:46):
Shalaan, you're also a graduate of ASCO's Leadership Development Program and
you've held committee positions at ASCO and at ECOG at ACRIN. Can you describe how
these leadership experiences have helped you shape your goals and your pathway?
SHAALAN BEG (38:02):
I got bit by the leadership development bug through a leadership program
that UT Southwestern had. And you have to realize for a lot of doctors, we kind of stumble through
our training because we're good test takers. And we're book smart. Sometimes that could come at
(38:26):
the expense of other aspects of our battery of skills. For me it was really important to
realize that leadership development, being able to lead a team and grow professionally is actually,
there's a science to that as well.I always used to think that great
leaders are born and not developed. And once I realized there's a method to it, I've been very,
(38:52):
very hungry to learn more and more in that space and to apply those in real time,
the positions that I've held. And it's a process. I don't think that any leader will ever say that
they have learned everything there is and we all learn from experiences more than we do in courses.
But, again, the realization there, if I link it to the clinical research activities, is how can
(39:16):
you build a program where research coordinators and research staff want to join your team and
not your colleagues' team? How do you build a program where fellows and trainees come to you
as opposed to other folks and you're able to pick folks to work on your team? And there are aspects
around developing the team, communicating your leadership, communicating your ideas and then
(39:39):
making sure that those folks are being developed and their goals are met, which for me was very
important in order to be able to be successful in completing my pancreatic cancer clinical trials.
And it was that connection which a lot of us will learn through the process of time by
getting knocked around a little bit by mistakes that we make. And I'm sure you have stories to
(40:03):
tell. I certainly have stories to tell. But you know, if these leadership courses and
leadership experiences can help us have more self-awareness and make us more efficient and
better stewards of our resources, then why not?And the ASCO Leadership Development Program was
a fabulous experience, which not only was an introduction to the skills which the
(40:29):
leader should have, but also was a way to be introduced to the ASCO community in a way that
you understand how ASCO functions, what are the levers that they have that they can pull
and that they can influence and where we can see ourselves. And that has led to a series of
(40:49):
relationships within ASCO and responsibilities within ASCO, which has been the highlight of
a lot of the work that I do and definitely amongst the months that I've enjoyed the most.
OLIVER BOGLER (41:01):
I forgot to expand the acronym ASCO, the American Society for Clinical Oncology.
So clearly a very important group to you.My last question, what advice would you
give to someone who might be listening, who is fascinated by your path and your work
and is interested in following in your footsteps? What would you say to them?
SHAALAN BEG (41:23):
I would lean on one of my favorite TV shows,
Ted Lasso, and say, be curious. I think the exact phrase is be curious,
not judgmental. And ask questions. People will appreciate you asking questions.
(41:44):
You'll be surprised by what other people are thinking about when you express some curiosity,
when you show interest in what folks are doing. And for me, it really is about the journey. Yes,
the destination is important. We all want to change the way cancer is treated and cancer
(42:06):
care delivery is administered. But it is about the journey and how we make that change and how the
community comes along in that journey as well.OLIVER BOGLER: You know, I hear they're
making a new season. So.SHAALAN BEG: I can't wait.
(42:27):
[music]
OLIVER BOGLER (42:28):
All right.
Now it's time for a segment we call Your Turn because it's a chance for
our listeners to send in a recommendation that they would like to share. If you're listening,
then you're invited to take your turn. Send us a tip for a book, a video,
a podcast or a talk or anything you found inspirational or amusing or interesting.
You can send these to us at NCIICC@ nih.gov. Record a voice memo and send it along. We'll
(42:55):
play it on an upcoming episode. But now I'd like to invite our guest to take his turn.
SHAALAN BEG (43:00):
So I've become really interested in history. I don't know
if that's something that guys my age typically start getting interested in generally or not,
but in particular, there is a podcast called the Empire podcast. Oliver, are you English?
OLIVER BOGLER (43:19):
No, I'm German by background,
but I grew up in England. Did a lot of my growing up there, yeah.
SHAALAN BEG (43:23):
So you would appreciate the specific … they start off talking about the East India
Company and the British Empire and the influence of the East India Company and the British in
India. But there is a specific episode around the Koh-i-Noor diamond, which was the largest diamond,
and where it came from, how it exchanged hands, and they walk through many different empires and
(43:49):
different kingdoms that it goes through until it makes its way to London. And even after it gets
to London, how the Queen was viewing this and built relationships around it. So if you have
time, I would highly recommend the Empire podcast. And if you're going to pick one,
(44:10):
I think that you'll find the Koh-i-Noor diamond episode very interesting, but then they do go
on and talk about other empires as well. And the hosts are fairly engaging as well.
OLIVER BOGLER (44:21):
That sounds great. Yeah, I'm going to give that a listen and we'll
drop a link in the show notes. Thanks for that.I'm also going to make a very brief recommendation
for a very brief book. It's called 300 Arguments. It's by Sarah Manguso. And it's one of those books
that you sometimes see at the counter there at the bookstore and you sort of pick it
up. So I picked this up on a odd chance a few months back. And it's basically, as she says,
(44:47):
“think of this as a short book composed entirely of what I hoped would be a long books quotable
passages”. So it's just little statements that are little, you know, they're food for thought
or they're stimulus for thought. I keep it here on my desk and between, you know, meetings and calls,
I sometimes pick it up and look at one of the ideas in here, one of the arguments,
(45:07):
and I enjoy that. So that's my recommendation.Dr. Beg, thank you so much for joining us
today and for sharing all your experience and your advice.
SHAALAN BEG (45:17):
Thank you very much for having me.
Oliver (45:19):
That’s all we have time for on today’s episode of Inside Cancer Careers! Thank you for
joining us and thank you to our guests.We want to hear from you – your stories,
your ideas and your feedback are welcome. You can reach us at NCIICC@nih.gov.
Inside Cancer Careers is a collaboration between NCI’s Office of Communications and Public Liaison
(45:44):
and the Center for Cancer Training. It is produced by Angela Jones, Astrid Masfar, and Maria Moten.
Join us every first and third Thursday of the month wherever you listen – subscribe
so you won’t miss an episode.If you have questions about
cancer or comments about this podcast, you can email us at NCIinfo@nih.gov or
(46:07):
call us at 800-422-6237. And please be sure to mention Inside Cancer Careers in your query.
We are a production of the U.S. Department of Health and Human Services,
National Institutes of Health, National Cancer Institute. Thanks for listening.
Hello and welcome to Inside Cancer Careers, a podcast from the National
Cancer Institute where we explore all the different ways people fight cancer
and hear their stories. I'm your host, Oliver Bogler from NCI's Center for Cancer Training.
Today, we're talking about the challenging issues surrounding clinical trials,
particularly how they can keep up with the very encouraging increase in new potential
(00:26):
clinical interventions being developed.Listen through to the end to hear our guest
make an interesting recommendation and where we invite you to take your turn. And of course,
we're always glad to get your feedback on what you hear and suggestions on what you might like
us to cover. The show's email is NCICC@nih.gov.Our guest today is Dr. Shaalan Beg, Senior Advisor
(00:48):
for Clinical Research at the NCI and a Principal Investigator at Science 37. Welcome, Dr. Beg.
SHAALAN BEG (00:55):
Thank you for having me. This is amazing.
OLIVER BOGLER (00:58):
So the increase in potential interventions for cancer,
while itself is good news, has led to a bottleneck at the clinical trial
stage. Sounds like a good problem to have, but still a problem, right?
SHAALAN BEG (01:10):
Yeah, we are in a situation where the scientific discoveries from
the lab are piling up and the clinical trial infrastructure is just not ready to test those
discoveries into the clinic in an efficient manner, which means that there's a backlog,
(01:34):
which means that innovative scientific approaches to help treat cancer are not
making their way into the clinic for clinical trials. And in oncology, where clinical trials
are largely considered part of standard of care, that means that in frequent situations,
(01:56):
that bottleneck is preventing access for standard of care for a lot of people with cancer.
OLIVER BOGLER (02:02):
So what are the main challenges
in the infrastructure that you see? How can they be overcome?
SHAALAN BEG (02:08):
I think about them in three different buckets. One is what are the
different hypotheses or observations from the lab or our non-clinical observations that we want
to study more formally in a prospective manner.The second is the infrastructure to operationalize
(02:29):
clinical trials in a manner which is compliant, in a manner which is ensuring
patient safety and high integrity data.And the third is having the ability to
have a workforce that can support this clinical infrastructure. And when I think about workforce,
(02:51):
I think about not just the postdocs and the students and the fellows and residents,
I also think about the development of our clinical research coordinators and data
specialists and administrators for the clinical trial infrastructure.
And then of course, principle investigators who are largely responsible for coming up
with innovative ideas, defining the strategy to translate those discoveries into the clinic and
(03:17):
then leading the entire initiative. And all of this comes before we even have the data
that's required to submit for regulatory purposes. You know, I don't think that
that's something that we can even talk about because the bottleneck is really much earlier.
OLIVER BOGLER (03:35):
So I'm a cancer survivor and I've had the privilege of participating in a couple
of clinical trials. So from a patient point of view, I sort of understand it,
right? You read a protocol, you read all the guidance and the cautions and then you sign it.
And then in my case, I had an immunotherapy to prevent the recurrence of my breast cancer. It
was a HER2 peptide immunization. But looking at it from the other side, from your side,
(04:00):
there's a lot to clinical trials. Can you sort of unpack for us a little bit, like,
okay, you are a clinician investigator, you have a great idea, and you're like,
I need to do a trial. What does the road ahead look like for you?
SHAALAN BEG (04:14):
As an investigator, the first thing that I think about when I see that
there's a new discovery that has potential applications at clinic is ‘does this match
the patients that I see in my clinic?’ Am I able to translate this discovery in a way that it can
make a short-term immediate-ish impact on the patients who come through my clinic?
(04:40):
The clinic that I largely participated in was focused on GI cancers and over
the years gravitated more to pancreas and biliary cancers. And so I would think about
those opportunities in a disease specific way and that allowed me to go deep into understanding the
(05:01):
various mechanisms that rule the disease of my interest and take it from there.
So there has to be a match between the hypothesis and the access for patients. I say that and it
seems like it's pretty obvious, but sometimes it isn't. And one of the most common reasons that
(05:23):
clinical trials are unsuccessful is that the clinical trial was not able to accrue patients
in a specified timeline to the extent that the science has moved on and the
trial may not have even completed enrollment.So that's first is ‘do I have the patients
that who can benefit from this clinical study?’ Second is really the, I guess that's also number
(05:48):
one is the science behind the proposal and is the rationale sound? Is there a clear logic in terms
of what allows me as a not a basic scientist to understand the potential mechanism on how
this intervention can modify the treatment?And is there a path to move that forward?
(06:13):
Something as simple as how is the drug going to be delivered? How is the treatment,
what medications can it be combined with? Do those fit in a clinical development paradigm,
which can be accepted into the clinic? And as a clinical investigator, we think a lot about how to
dovetail those new innovations into standard of care.
(06:36):
In diseases such as HER2 positive breast cancer, there are many existing treatments
that are out there that are effective for that disease. So a new discovery in that
space needs to be able to be a step above what is already available, or it needs to position
itself in a situation where the existing treatments have already been unsuccessful.
(07:00):
In a disease such as pancreatic cancer where there are not a lot of effective treatments, even the
approved treatments are modestly effective, the bar for our ability to be innovative and ask more
provocative questions in the clinic and expose our patients to such a hypothesis is sometimes lower
because both the people with cancer are looking for more innovative treatments. The standard
(07:25):
treatment is not something they're really excited and receiving either. And on the investigator
perspective, it's the same way. We want to be able to move those opportunities forward.
OLIVER BOGLER (07:35):
So you mentioned one critical element, and you mentioned several, but one was
having enough patients to accrue sufficient numbers to complete the trial. Obviously,
the rarer the tumor, the bigger that challenge is. So NCI and other groups
have built these networks, these cooperative groups, right, that allow clinical trials to
(07:55):
be simultaneously opened across multiple centers to sort of address that problem.
But it's not always effective. Even if you have a cooperative group,
I know from what I've heard from you and others that some trials just don't accrue. So is that
because they are not offering something that people want or what else is going on there?
SHAALAN BEG (08:15):
So we're a victim of our own success. As we start to understand cancer biology and what
drives cancers in people and how cancers are becoming resistant to approved treatments,
we have started to classify cancers into smaller and smaller subgroup. So people don't just
have breast cancer anymore. They now have ER positive or negative, PR positive or negative,
(08:39):
HER2 positive or negative breast cancer. You don't just have colon cancer, you now have BRAF
mutated or wild type, KRAS mutated or wild type, and then every type of KRAS varies as well. So as
we understand cancer and cancer biology better, we have started to split the diseases into more
(09:00):
restrictive buckets, which means that most cancers that we're doing studies on are rare tumors.
And there are not a lot of practices that see a critical mass of every one of those diseases where
they could significantly accrue a critical number of patients. That again leads into another aspect
(09:24):
which you and I have talked a lot about, which is the centers, let's say there's a center that
focuses on triple negative breast cancer or an investigator who focuses on triple negative breast
cancer, that investigator probably resides in an academic medical center in an urban environment.
So if you have a drug which is looking for triple negative breast cancer, you keep going to such
investigators who have built a reputation around triple negative breast cancer. They
(09:47):
may fill up your study, but then you may end up with a lot of urban patients who don't represent
the typical patient who has triple negative breast cancer because by large, most of those
patients are going to be seen in the community.So now when as a sponsor or when you're someone
who's running that clinical trial or thinking about accruing a clinical trial, you want the
(10:11):
patients who are going on that clinical trial to be representative of the patients who have
that disease. And you can't just accrue a large study which has regulatory intent with a handful
of sites. So then you start taking bets as an investigator. I don't know that's the correct term
(10:33):
to say take or not, but you open more sites that will be able to enroll more patients on clinical
trials and some of them will deliver, but a lot won't. And I think as a general rule, I think the
80-20 rule that applies to a lot of things in the world and in our daily lives also applies
(10:54):
here and 80 % of the enrollment takes place from 20 % of the sites. So you still end up with a lot
of sites that end up underperforming. When you're overseeing a network or you're an investigator or
you have a strict timeline and a strict budget, that can sometimes feel very unsustainable.
OLIVER BOGLER (11:12):
So the promise both of personalized medicine, right? We've heard of that buzzword now
for more than a decade. But what you're saying is that while it's a wonderful idea and concept,
it actually makes it very challenging to develop clinical trials that can test it effectively.
Plus, the unevenness in how the health care delivery system is built overall means
(11:34):
that not everybody can participate. Those sound like really significant challenges.
So you joined the NCI to take a look at some of these big challenges and tackle
them. And I know that you're also working with a group in the NCI's
Division of Cancer Treatment and Diagnosis, the Virtual Clinical Trials Office. Can you
tell us about the work that you're doing to try and take on some of these issues?
SHAALAN BEG (11:56):
Yeah, the Virtual Clinical Trials Office is the brainchild of Dr. Jim Doroshow at
DCTD and the NCI, who is looking to see how we can apply services centrally to help improve clinical
trial patient identification and screening at various sites. Related to the question that
(12:22):
you had before, all clinical trials have fairly restrictive inclusion and exclusion criteria.
Some trials are looking for left-handed unicorns is what one of my collaborators once mentioned.
And finding patients for those studies becomes challenging. And we know that patients and people
who have cancer are very likely to enroll on a clinical trial if they're only asked.
(12:49):
And if we can come up with ways to help increase that rate that that can then
lead to higher enrollments onto clinical trials. And sometimes the physicians who
are caring for those patients are not aware of the study, or they're not aware that the
patient who they have is eligible for that study. may not be front of mind,
(13:10):
and they may not know about the study at the right time of the patient's care.
So, what the virtual trials office is accomplishing is to use resources at NCI to
identify people and screen them for eligibility across various clinical sites to help support
(13:36):
NCI-funded clinical trials activity. And it's been successful in terms of understanding what
the nuances are for offering these services to the sites, contractual agreements,
communication with sites, making sure that there is sufficient on-site resources to then take over
once a patient has been enrolled. And that's one mechanism with which we can improve enrollment
(14:04):
on cancer clinical trials so that our trials don't last longer and that the sites are also
looking for additional resources so they can focus their staff's effort on people who are
highly probable to enroll in clinical trials and not end up not enrolling on the study.
These teams of nurses and coordinators are also supporting sites on activities such as adverse
(14:32):
event reporting and data cleanup. And this is a tremendous resource which we are learning to,
responding to what feedback we're getting from sites to help curate
the services that are available.There are other examples beyond
this experience as well of centers developing hub and spoke models to provide support to
(14:53):
less resourced clinical satellite or community clinical research centers. And it's important
for every site to be able to understand exactly what their needs are, what their PIs needs are,
what their site staff's needs are, and to be able to curate those services in a way that
takes the load off of the site themselves.And you can already imagine that as we learn
(15:15):
more about providing these services for patient identification and eligibility screening, that
can then be translated into other additional steps such as medication shipment to a patient's home,
adverse event collection at the patient's home using telemedicine for those resources. And
the NIH has had a few successful experiences in leading and supporting these studies during COVID.
(15:41):
And as we are thinking about factors such as interstate medical licensure, shipping medications
across state lines and how that varies between oral and IV medications, we're able to set up
the framework for us to use these novel mechanisms to make clinical trials more accessible so that
(16:02):
patients, people who have cancer, doctors who are caring for those folks who otherwise may not have
a supportive team to run clinical trials can have some additional support so that they can make
those trials available for their participants.The NCI benefits by being able to increase
access of their trials in the community, the sites and the doctors and patients who
(16:24):
get their care there benefit by being able to access those resources closer to home as well.
OLIVER BOGLER (16:31):
So you've mentioned telemedicine as one facilitator of this idea of the Virtual
Clinical Trials Office that also allows more people to participate. I wonder if you
also see opportunities, for example, I could imagine an AI sort of looking metaphorically
over the shoulder of the physician as they are treating a patient and saying something like,
(16:53):
this patient might have the characteristics that match this trial that's currently on offer. And
at the right time, as you said, sort of to give that that critical piece
of information. Is that the kind of future that we can look forward to?
SHAALAN BEG (17:07):
Yeah. The NCI is supporting the USCDI+ cancer initiative, which is looking
to structure EMR data elements within the electronic medical records and to optimize
that list to enable clinical trial matching. And that's precisely the vision that that initiative
has is how can we automate a lot of the patient characteristics for identifying
(17:34):
people for a clinical trial. When we go down the list of inclusion and exclusion criteria,
I'll give you an example. When it comes to age, demographics, or kidney function,
or even past medical history, those are probably easily, quote unquote, I'm air quoting here,
extractable from medical records. But when it comes to lines of therapy, that's one of
(17:58):
the very tricky inclusion criteria to automate because it requires the machine to be able to
interpret from the physician's note, what are the prior lines of therapy, recalibrate that into the
language which is present in the protocol and see if that matches or not. And even if you put five
oncologists in the room together and ask them to document a structured patient's prior treatments,
(18:24):
they're going to structure it 10 different ways.There is no standard and I don't think there
necessarily needs to be a standard, but there is no standard on documenting factors such as
lines of therapy. So there are elements around data residing in the electronic medical records
that is a barrier to us being able to create this trial matching AI bot in the background.
(18:50):
The second component for being able to match patients onto a clinical trial is actually the
way the data resides in the clinical trial protocols themselves. Surprise, surprise,
there are many different ways that the protocols are structured and there is very little agreement
(19:11):
in how inclusion exclusion criteria are even structured, which makes it hard to digitize
those criteria and be able to apply them.And there are initiatives, some supported
by the FDA even, that is encouraging the deployment of digital or structured protocols,
I should say, where the schedule of assessments and inclusion exclusion
(19:32):
criteria, dose modifications are all built in a harmonized way so that these tools can then
start to read the protocols in a way that they can then find the matched participant as well.
So there's a lot of work that's happening on both ends of this matching equation both in being able
to identify patients in a timely way using structured and unstructured data in electronic
(19:58):
medical records, and then on the other end, to be able to interpret clinical trial protocols.
And there are a lot of challenges, and the biggest challenge for both of these
is really is the way we've been doing it all the time leading up to here, because it does
require us to change behaviors which we have been very used to for decades and serve very
(20:20):
good purposes for a very long period of time. And then there is a process that needs to go in
terms of uptake and acceptance and optimization. And we are seeing stakeholders taking that on.
OLIVER BOGLER (20:34):
Sounds like an exciting time to be in this field. But I hear what you're saying.
You've got to change the culture alongside the technology and to really accomplish the goal.
I wanted to ask you about your role at Science 37. You served there as VP of oncology,
and you're still a principal investigator there,
if I'm correct. And you oversaw the decentralized clinical trial program there for oncology.
(21:00):
What was your experience in that group, and how has that helped you in your current role?
SHAALAN BEG (21:05):
Yeah. So decentralized clinical trials is a term that gained a lot of popularity
around the COVID pandemic. when a lot of clinical trial centers and offices were shut down, frankly,
or patients were not coming into the offices at the same rate. We then
(21:28):
realized that a lot of the components that are required to oversee someone's participation on
a clinical trial have already existed. Like there was FDA guidance in terms of decentralized trials.
There's some language out there even before COVID came about around the interpretation of Form 1572,
(21:50):
which is a regulatory document that the FDA uses.But we saw the demand for decentralized clinical
trial services surge during COVID. And when I use the phrase decentralized trials, I want to focus
on a couple of elements. We're talking about any clinical trial related procedure that takes place
(22:12):
at a location that is not the investigator's location. So it could be the patient's home,
it could be another doctor's office, it could be my colleague's office, just not my own office.
And when we talk about decentralized clinical trials, we don't necessarily need to think of
an entire clinical trial as being decentralized versus not. There are different elements within
(22:34):
the clinical trial. The physical exam is one element. The history is one element. Collecting
the vitals is an element. Getting imaging lab collections are all specific elements. And each
one of those could be done centrally at the PI's own office, which is the way we've been
doing clinical trials throughout, or they could be decentralized to where we can perform those
(22:59):
activities at site other than the investigator.What I just described to you right now is the
synthesis of lot of learnings that we went through over the last many years. And what's been very,
I've been very happy to see is that when we started to talk about decentralized
clinical trials, and this is a concept that's been around for a very long time,
but when we started to talk about this in the space of oncology, the initial reactions were,
(23:26):
that's never gonna work because in oncology, the drugs are too toxic and the patients are too sick
and how are we going to enable these studies?And what we found through varying experiences is
that for the right drug, with the right study question for the right patient population,
it does have a role. And when we surveyed large comprehensive cancer centers and asked
(23:52):
them about their use on decentralized trial elements, 100 % of their sites now say that
they have had experiences with some component of decentralized trials. That could be e-consent,
it could be telemedicine, it could be getting scans close to where the patients are. But it's
making its way into oncology, surely and steadily.During COVID, when study-related activity was
(24:15):
halted at lot of centers, there was a clinical trial which was structured in a way to administer
subcutaneous treatment for HER2-positive breast cancer at the participants' homes. So
patients were screened and identified at 12 large academic medical centers. After those patients
(24:38):
were enrolled, the entire care was done using a telemedicine platform with nurses going to the
patient's home, administering the medication, collecting blood samples, even doing a bedside
ejection fraction assessment for the heart.And this was a study with an intent to expand
regulatory labeling of the drug that was being studied. And the study ended up enrolling about
(25:04):
140 patients and 26 % of patients who enrolled on that study were Black, Hispanic or Asian.
Before the study, I would have said, you know, I don't know what the cultural acceptance even
of receiving cancer therapy at home is going to be. And what we've realized is again, you know,
we need to ask our patients on what their preferences are. These decentralized methods
(25:29):
have a significant advantage of reducing participant burden for a clinical trial.
The participant's child doesn't have to take off of work in order to drive their parent
to the office for study-related visits. And granted, we're not going to do liver biopsies
on the dining table or administer RT therapy in the living room. But especially when you look at
(25:54):
the new treatments that are coming in through the pipeline. We're looking at lot of sub-Q
medications. We're looking at oral medications, IM medications that have side effect profiles which
are conducive to administration at home. There are more trials that we can impact using these tools.
And why it's important for us to think about this in the clinical trial space is that we're seeing
(26:17):
standard of care administration evolving as well. The University of Pennsylvania and the Huntsman
Cancer Center in Salt Lake City have at-home programs for delivering their normal standard
of care cancer treatments at home. There's a list, the last time I checked, of 15 anti-cancer
treatments, infusions, that they have deemed safe to be given at home. That includes platinum drugs,
(26:42):
includes some new therapy medications. So essentially, medications that don't have a high
risk of infusion reactions can be done at home. So we need to keep an eye on how that is evolving
and make sure our trials are able to accommodate.So there are a lot of challenges in that space.
And I would say one of the major challenges is to provide sites and investigators
(27:06):
the right SOPs to be able to execute these clinical trials in a safe and compliant way.
At the end of the day, we want to make sure that our participants' safety was not compromised in
any way and the integrity of the data that we collected was not compromised in any way. And
(27:26):
depending on what element we're looking to decentralize for what type of study,
those two can line up very nicely, in which case we're seeing it move forward or not, in which case
we keep doing work the way we've had in the past.And the FDA came up with guidance which helped
address many of the concerns that sponsors and investigators have for being able to
(27:53):
operationalize these clinical trials. And now we're seeing those guidances percolate through
the societies and through the communities and sites are looking at it to see what their roles
may be. So I think the next few years are going to be very exciting as we see centers, again, learn
from NCI's virtual trial office experience and what's happening outside as well to operationalize
studies even within their own network.And I hope that cancer centers can completely
(28:20):
redefine what they consider is their catchment area. Because oftentimes, cancer centers will
feel that patients who walk through their doors are their patients. But now with these tools and
services that we have available, we are able to provide access for discoveries in our hospitals
(28:45):
and clinics and cancer centers into areas which otherwise would not have been accessible.
OLIVER BOGLER (28:51):
That sounds like phenomenally important work. Thank you. Thank you for doing
it. We're going to take a short break. And when we come back, we'll talk about careers.
[music]
Calling all senior oncologists committed to community oncology and reducing health
disparities! Are you passionate about shaping the next generation of researchers?
(29:14):
Apply to The Worta McCaskill-Stevens Career Development Award for Community Oncology and
Prevention Research (K12) program and mentor promising clinical scientists.
This unique NCI program supports the training of clinical scientists
in community cancer prevention, screening, intervention, control,
and treatment research. The program welcomes proposals for innovative research and career
(29:38):
development programs with an equity lens and a focus on increasing diversity in clinical trials.
As a program leader, you would guide clinical scientists from various oncology specialties as
they conduct research, potentially even leading their own independent clinical
trials. This is a chance to leverage your expertise and make a lasting impact
(29:58):
on cancer research and care in underserved communities.
For more information about the McCaskill-Stevens K12, including
how to apply and our staff contact details, visit our webpage – link is in the shownotes.
[music ends]
All right. We are back. I'm always curious on what got people
(30:22):
started in their path to medicine and science. What was that for you?
SHAALAN BEG (30:27):
You know, if you were to go back and read my personal statement for medical school,
it probably looked like a lot of others, right? In terms of wanting to go into medicine with the
desire to enter a profession where you get to help people day in and day out.
(30:48):
And as I started to go through my journey for medical school and residency and fellowship,
I was looking for a field which was in evolution, was evolving quickly, new discoveries moving into
the clinic that was exciting and growing and oncology checked a lot of those boxes.
(31:11):
I think my pursuit into the space of oncology, there are probably some overrepresented influence
by a few mentors and some patients who I've cared for over the years that shaped my thinking,
that made it clear for me on how I want to spend my time and go through the process. The
(31:34):
last many years have been absolutely amazing in terms of being able to have the privilege
to care for people who have cancer and work with scientists who have exciting discoveries
and want to move that into the clinic. And then from an operational perspective,
building programs where we can create change and do things in a way that helps people's lives.
OLIVER BOGLER (32:03):
I'm also curious about how you decided to take on this sort
of big challenge of overall of clinical trial. I don't know what the right word
is delivery clinical trial performance. It seems like everything right. You
already mentioned your specialty is in GI cancer and pancreatic cancer specifically,
I guess. But in addition to this very challenging clinical practice what made you think OK I also
(32:28):
want to work on this bigger problem of structural issues around clinical trials.
SHAALAN BEG (32:34):
I was the medical director for our clinical trials office at an NCI designated
cancer center at UT Southwestern in Dallas. And I started to appreciate the impact of operational
efficiencies, the importance of developing team members, helping them map out their careers,
(33:05):
the role of stakeholder engagement in being able to successfully pull off a
clinical trial or a clinical trial ecosystem.Then I think I got bit by the informatics bug
and really started to see the impact of electronic medical records and data that's
emanating from electronic medical records. Our ability to change how we generate evidence using
(33:29):
these tools. And for me, it's being able to be in a position where I can help take advantage
of the developments that are taking place around me. Like 10 years ago, it was electronic medical
records and it was harmonizing the data. And now we're seeing impacts on AI. And for me
(33:50):
being part of that change and maybe having a small part in defining the narrative and
how people talk about applying these tools in the oncology space was something which was important.
I also got annoyed when I would meet my friends and colleagues and we would talk about our
(34:12):
programs that we all were doing a reasonably good job about offering these services for patients who
walk through our doors. And I mentioned this earlier, but that we weren't doing enough for
people who couldn't walk through our doors. And that was really the driver for me to be able to
think differently because there was an opportunity to really grab these opportunities, these
(34:35):
developments, grab the bull by its horns and kind see what we can make with it.
And we're still very early in writing that chapter and there's a lot of work that needs to be done,
but I think the direction is clearly changing. And I can tell you that the direction is
changing because when I started to talk about decentralized clinical trials in oncology,
(34:56):
people said that's never going to happen. Oncology is too difficult. And now people are saying,
well, we've always been doing that anyway.I think there's a difference in how it's
being perceived, but there's still a long way to go. I don't think that that's just one tool
that we have. And I think you mentioned AI, what those applications are going to
(35:19):
look like. We have no idea how evidence generation is going to be in 10 years.
OLIVER BOGLER (35:24):
So you've also been involved in the Pancreatic Cancer Action Network,
and I wonder if you could tell us a little bit about that experience
and how that has influenced your approach to patient-centric research.
SHAALAN BEG (35:36):
So when I was a junior investigator trying to find my way in the scary world of
GI oncology, I had the privilege of working with a scientific basic science collaborator,
Dr. David Boothman, on work that he was doing around KRAS mutated cancers.
(35:57):
And that relationship led to a series of successful grant applications and
clinical trials that were funded and studies that we ran in Dallas as well.
And those were initially supported by the Pancreatic Cancer Action Network.
I credit them tremendously for supporting my early work and credit them for me being in the field and
(36:26):
having an interest in continuing to give back to the community. Every year, PanCan has a 5K where
we've had a team. And the first time we had a team, it was me and we didn't have a team,
we showed up to - Purple Stride is the name of the 5K - David Boothman and I showed up, we grabbed
(36:47):
a couple of lawn chairs and we had a poster that we grabbed from one of the booths when nobody was
looking and we wrote UT Southwestern and we tied them to those chairs and we just stood there and
started to see patients. And that evolved into us having a booth. It grew to our team to now, know,
the UT Southwestern has three teams and raised a lot of money and, you know, is a force over there.
(37:11):
And again, it's not just the folks at PanCAN, but also the community that PanCAN had built around
pancreatic cancer was my tribe or is my tribe. That's where I found my mentors. That's where I
found my colleagues where peer mentorship is a thing. Talking to folks who are grappling with
similar challenges that I may be at that phase of my career and PanCAN provided that community,
(37:36):
they provided those resources and that mission and they'll always have that space in my heart.
So still have my Pan Can pin on my blazer if you see me at oncology conferences.
OLIVER BOGLER (37:46):
Shalaan, you're also a graduate of ASCO's Leadership Development Program and
you've held committee positions at ASCO and at ECOG at ACRIN. Can you describe how
these leadership experiences have helped you shape your goals and your pathway?
SHAALAN BEG (38:02):
I got bit by the leadership development bug through a leadership program
that UT Southwestern had. And you have to realize for a lot of doctors, we kind of stumble through
our training because we're good test takers. And we're book smart. Sometimes that could come at
(38:26):
the expense of other aspects of our battery of skills. For me it was really important to
realize that leadership development, being able to lead a team and grow professionally is actually,
there's a science to that as well.I always used to think that great
leaders are born and not developed. And once I realized there's a method to it, I've been very,
(38:52):
very hungry to learn more and more in that space and to apply those in real time,
the positions that I've held. And it's a process. I don't think that any leader will ever say that
they have learned everything there is and we all learn from experiences more than we do in courses.
But, again, the realization there, if I link it to the clinical research activities, is how can
(39:16):
you build a program where research coordinators and research staff want to join your team and
not your colleagues' team? How do you build a program where fellows and trainees come to you
as opposed to other folks and you're able to pick folks to work on your team? And there are aspects
around developing the team, communicating your leadership, communicating your ideas and then
(39:39):
making sure that those folks are being developed and their goals are met, which for me was very
important in order to be able to be successful in completing my pancreatic cancer clinical trials.
And it was that connection which a lot of us will learn through the process of time by
getting knocked around a little bit by mistakes that we make. And I'm sure you have stories to
(40:03):
tell. I certainly have stories to tell. But you know, if these leadership courses and
leadership experiences can help us have more self-awareness and make us more efficient and
better stewards of our resources, then why not?And the ASCO Leadership Development Program was
a fabulous experience, which not only was an introduction to the skills which the
(40:29):
leader should have, but also was a way to be introduced to the ASCO community in a way that
you understand how ASCO functions, what are the levers that they have that they can pull
and that they can influence and where we can see ourselves. And that has led to a series of
(40:49):
relationships within ASCO and responsibilities within ASCO, which has been the highlight of
a lot of the work that I do and definitely amongst the months that I've enjoyed the most.
OLIVER BOGLER (41:01):
I forgot to expand the acronym ASCO, the American Society for Clinical Oncology.
So clearly a very important group to you.My last question, what advice would you
give to someone who might be listening, who is fascinated by your path and your work
and is interested in following in your footsteps? What would you say to them?
SHAALAN BEG (41:23):
I would lean on one of my favorite TV shows,
Ted Lasso, and say, be curious. I think the exact phrase is be curious,
not judgmental. And ask questions. People will appreciate you asking questions.
(41:44):
You'll be surprised by what other people are thinking about when you express some curiosity,
when you show interest in what folks are doing. And for me, it really is about the journey. Yes,
the destination is important. We all want to change the way cancer is treated and cancer
(42:06):
care delivery is administered. But it is about the journey and how we make that change and how the
community comes along in that journey as well.OLIVER BOGLER: You know, I hear they're
making a new season. So.SHAALAN BEG: I can't wait.
(42:27):
[music]
OLIVER BOGLER (42:28):
All right.
Now it's time for a segment we call Your Turn because it's a chance for
our listeners to send in a recommendation that they would like to share. If you're listening,
then you're invited to take your turn. Send us a tip for a book, a video,
a podcast or a talk or anything you found inspirational or amusing or interesting.
You can send these to us at NCIICC@ nih.gov. Record a voice memo and send it along. We'll
(42:55):
play it on an upcoming episode. But now I'd like to invite our guest to take his turn.
SHAALAN BEG (43:00):
So I've become really interested in history. I don't know
if that's something that guys my age typically start getting interested in generally or not,
but in particular, there is a podcast called the Empire podcast. Oliver, are you English?
OLIVER BOGLER (43:19):
No, I'm German by background,
but I grew up in England. Did a lot of my growing up there, yeah.
SHAALAN BEG (43:23):
So you would appreciate the specific … they start off talking about the East India
Company and the British Empire and the influence of the East India Company and the British in
India. But there is a specific episode around the Koh-i-Noor diamond, which was the largest diamond,
and where it came from, how it exchanged hands, and they walk through many different empires and
(43:49):
different kingdoms that it goes through until it makes its way to London. And even after it gets
to London, how the Queen was viewing this and built relationships around it. So if you have
time, I would highly recommend the Empire podcast. And if you're going to pick one,
(44:10):
I think that you'll find the Koh-i-Noor diamond episode very interesting, but then they do go
on and talk about other empires as well. And the hosts are fairly engaging as well.
OLIVER BOGLER (44:21):
That sounds great. Yeah, I'm going to give that a listen and we'll
drop a link in the show notes. Thanks for that.I'm also going to make a very brief recommendation
for a very brief book. It's called 300 Arguments. It's by Sarah Manguso. And it's one of those books
that you sometimes see at the counter there at the bookstore and you sort of pick it
up. So I picked this up on a odd chance a few months back. And it's basically, as she says,
(44:47):
“think of this as a short book composed entirely of what I hoped would be a long books quotable
passages”. So it's just little statements that are little, you know, they're food for thought
or they're stimulus for thought. I keep it here on my desk and between, you know, meetings and calls,
I sometimes pick it up and look at one of the ideas in here, one of the arguments,
(45:07):
and I enjoy that. So that's my recommendation.Dr. Beg, thank you so much for joining us
today and for sharing all your experience and your advice.
SHAALAN BEG (45:17):
Thank you very much for having me.
Oliver (45:19):
That’s all we have time for on today’s episode of Inside Cancer Careers! Thank you for
joining us and thank you to our guests.We want to hear from you – your stories,
your ideas and your feedback are welcome. You can reach us at NCIICC@nih.gov.
Inside Cancer Careers is a collaboration between NCI’s Office of Communications and Public Liaison
(45:44):
and the Center for Cancer Training. It is produced by Angela Jones, Astrid Masfar, and Maria Moten.
Join us every first and third Thursday of the month wherever you listen – subscribe
so you won’t miss an episode.If you have questions about
cancer or comments about this podcast, you can email us at NCIinfo@nih.gov or
(46:07):
call us at 800-422-6237. And please be sure to mention Inside Cancer Careers in your query.
We are a production of the U.S. Department of Health and Human Services,
National Institutes of Health, National Cancer Institute. Thanks for listening.
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