January 28, 2025 • 17 mins
Podcast Episode Description
🎙️ The Deep Dive: Mapping the Journey of Drug Development 🌍
In this captivating episode of The Deep Dive, we embark on the fascinating and intricate journey of drug development. From the first spark of scientific curiosity in preclinical research to the rigorous clinical trials and ongoing post-market surveillance, we break down the process into approachable, bite-sized insights using a spiral learning approach.
Discover the critical roles of the FDA and ICH guidelines in ensuring new drugs are both safe and effective. Learn about key concepts such as phase zero trials, double-blind studies, and the importance of pharmacovigilance in keeping medicines safe long after they hit the market.
Using relatable analogies and real-world examples, we shed light on how a single drug makes it from the lab to your medicine cabinet. Whether you're a curious learner or a seasoned professional, this episode promises to deepen your understanding of the science, ethics, and human ingenuity driving modern medicine.
Join us on this exploration of the challenges, innovations, and collaboration shaping the future of healthcare.
🎧 Tune in now and prepare to dive deep into the world of drug development!
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:00):
Welcome to the deep dive.
(00:02):
We're gonna be looking at something that affect all of us
over the next few episodes, and that is drug development.
It's a really long and complicated journey,
but we're gonna be using a spiral learning approach.
We can kind of break it down into these smaller pieces,
adding details, we kind of circle back.
Think of it like exploring a city.
(00:22):
First you get like a lay of the land from above,
and then you start zooming in on the streets
and the neighborhoods.
That's a great analogy.
And just like a city, there's always new stuff to discover
in drug development.
Right.
So we'll start today by mapping out those major phases.
So that's preclinical research, the clinical trials,
and finally post-marketing surveillance.
We're also gonna look at like the role of the FDA
(00:43):
and the ICH guidelines.
Okay.
See how they help to make sure that new drugs
are effective and safe for everyone.
So let's say like a new cholesterol drug
is making headlines.
What happened before it ended up on the pharmacy shelves?
Years of work for sure.
It all starts with that preclinical research.
That's where scientists are testing thousands
of potential compounds in the lab.
(01:04):
Okay.
And they might start with just a hunch about what might work.
They might even use computer modeling to design molecules.
It's almost like cracking a code.
They're looking for that perfect combination
that targets the disease without causing bad side effects.
So it's not just like mixing random chemicals together?
No, no.
There's a lot of strategy involved.
Absolutely, a lot of trial and error too.
(01:26):
Okay.
During preclinical, they're looking at how the drug
behaves in cells in animals,
how it's absorbed broken down by the body,
and of course its potential toxicity.
Okay.
So it's about getting enough evidence to move from
this might work to we can test this in humans.
Okay, so that brings us to clinical trials.
(01:47):
Yeah.
I always thought it was just one thing,
but it turns out there are multiple phases.
You got it.
We're gonna add another layer to phase zero.
Phase zero.
Okay.
So it's a really quick peek inside the human body.
We're talking a tiny dose to a few people,
not even enough to treat anything,
but just enough to see if the drug is behaving as expected.
Like does it reach the target?
(02:08):
How long does it stay in the system?
Okay.
It's all about confirming those assumptions
before we do larger trials.
It's a kind of like a dress rehearsal.
Perfect way to put it.
Then we go to phase one, which is all about safety.
A small group of healthy volunteers gets different doses.
Researchers are carefully watching for side effects,
figuring out a safe dose range,
(02:29):
and they're gathering information
about how the drug is interacting with the body.
So if you volunteer for a phase one trial,
you're really on the front lines of research.
That's right.
And without these brave volunteers,
we wouldn't be able to move forward.
But even if the drug gets through phase one,
it's still a long way to approval.
Right.
In phase two, we finally start to include patients
who have the condition we wanna treat.
(02:51):
This phase is still about safety,
but we are also starting to look at efficacy.
Does it actually work?
Can we measure a positive effect
in the people taking it compared to those who aren't?
So this is where we start seeing if the drug
actually works in the real world.
Exactly.
And if the results in phase two are promising,
we move to the big leagues phase three.
(03:12):
Oh, wow.
These are large scale trials,
sometimes thousands of patients,
all across multiple countries.
Wow.
Here we're confirming that the drug is effective,
the monitoring for rare side effects
that may not have shown up earlier,
and also comparing it to the treatments
that are already out there.
So this is where those ICH guidelines
that we mentioned come in.
Yeah.
(03:32):
It's like a rule book for these large trials, right?
You got it.
Ensures consistency and reliable research
no matter where it's happening.
The ICH or International Council for Harmonization,
it's basically a global team of regulators
and experts and pharmaceuticals
working to streamline drug development.
Okay.
Think about it.
Without these guidelines, companies would have to do
totally different trials for every single country
(03:55):
that they wanna sell their drug in.
That would be super expensive, time consuming,
and it could delay like life-saving treatments for years.
Wow.
So these guidelines really make sure
that new medicines reach patients safely and quickly.
Absolutely.
It's not just about the science either.
They also think about things like ethical considerations,
data collection, and even how the results are reported.
(04:18):
It's all about transparency and accountability
the whole way through.
Okay, so let's say that our cholesterol drug
has passed these three phases with flying colors.
Is it ready for prime time?
Not quite.
This is where the FDA steps in.
Okay.
They look at all the data from those preclinical
and clinical trials, assess the drug's safety,
its efficacy, its manufacturing process.
(04:39):
Okay.
It's a rigorous process, and it should be,
we're talking about giving this drug potentially
to millions of people.
So the FDA is like the last checkpoint.
Precisely.
Making sure everything is good
before it can be sold in the US.
Exactly.
And if the FDA gives it the thumbs up,
our cholesterol drug finally hits the market.
Okay.
But it still doesn't end there.
Oh, there's more.
(04:59):
I thought approval was the finish line.
It's more like a new starting line.
Okay.
Now we enter post-marketing surveillance.
So now the drug is used by a much wider group of people
than in the clinical trials.
Right.
This is how we find any very rare side effects
that didn't show up before.
And we can also see how well it works long-term
out in the real world.
So it's a process of always learning and refining
(05:21):
even after it's available to everyone.
Exactly.
The FDA is still involved too.
They monitor safety reports and evaluate new data.
Right.
They might even require more studies if they have to.
Wow.
It shows that drug development is always changing.
We're always learning new things
about how these medicines interact with our bodies.
This is all fascinating, but I have to admit,
(05:42):
I'm a little lost in all the phases and regulations.
I hear you.
It is a lot to take in, especially for our first dive.
But remember, we are taking that spiral learning approach.
So we'll keep coming back to these concepts
and adding new information each time.
That makes me feel better.
I am starting to see the big picture
and I'm ready to go deeper into these specific things
(06:02):
in our future episodes.
Me too.
But for now, let's just think about
how much goes into getting one single drug from the lab
to your medicine cabinet.
Right.
A real testament to human ingenuity, to science,
and to this commitment to making sure patients are safe.
I like that.
Beautifully said.
Thanks.
And on that note, we'll wrap up part one of our deep dive.
(06:25):
Join us next time as we get into those clinical trials.
Explore the world of study design control groups
and how we make sure there's no bias
so we can get the best results.
Sounds good.
Welcome back to the deep dive.
Last time we talked about,
you know how a potential drug goes from the lab
all the way to the pharmacy shelf,
passing through all that preclinical testing,
(06:46):
the phases of clinical trials.
It was amazing to think about all the steps.
And you mentioned the ICH guidelines.
So they make sure the trials are done consistently
across all the different countries.
It's like having a universal language
for doing medical research.
Exactly, making sure the quality and the reliability
is there no matter where the research is being done.
But let's zoom in on the clinical trials themselves today,
(07:09):
specifically how they're designed to minimize bias
and give us the most accurate picture
of whether a drug really works or not.
Okay, because I remember you talk about control groups.
Yes.
Why are they so important?
So imagine like you're trying a new workout routine
to let's say get stronger.
(07:30):
You go to the gym three times a week,
you do all the exercises,
and then after a month you feel stronger.
But how do you know for sure
if it was the routine that made that difference?
Maybe you were also getting more sleep
or you were eating healthier.
Or maybe you were just getting stronger naturally
because you're going to the gym more.
Right, you need something to compare it to.
Yeah, like a baseline.
In drug trials, the control group gives us that baseline.
(07:54):
So let's say we're testing a new pain reliever.
One group gets the actual drug
while the control group might get a placebo.
So it looks the same,
but it doesn't have any of the active ingredients.
Right, so like a sugar pill.
Exactly, so that way we can see
what the effect of the drug is.
Separate from other things
that might be making people feel different.
Wow, that's pretty clever.
(08:15):
But what about when you're comparing a new drug
to one that's already out there?
Uh huh, yeah.
You know, for the same condition.
That's called an active control group.
That's really important for figuring out
if a new drug is better than what we've already got.
Is it more effective?
Does it have less side effects?
Is it easier to take?
These are the questions we gotta answer
before we say, hey everybody go use this new treatment.
(08:37):
So picking the right kind of control group
is really important for getting good results.
Yes, very important.
You also talked about bias.
Yes.
Isn't science already objective?
It should be.
Right.
But bias can sneak into research
even when we don't mean for it to.
Let's say I'm a researcher who is super excited
about this new pain reliever I'm testing.
(08:59):
Right.
I might, without even realizing it,
treat the patients getting the real drug
differently from those who are getting the placebo.
Oh, okay.
Maybe I encourage them more
or I watch their symptoms more closely.
Right, so even little differences in how you treat people
can change how they respond.
Exactly, and that can mess up the results.
And that's why they do blinding in clinical trials.
(09:20):
You got it.
So that means neither the patients nor the researchers
know who is getting the real drug.
It's like a double blind taste test.
Right, you get a more honest opinion.
Exactly.
If you don't know what you're tasting.
Exactly.
Are there any other ways to minimize bias?
Absolutely, randomization.
Instead of the researchers choosing who goes in each group,
(09:41):
patients are assigned randomly, like flipping a coin.
This helps make sure both groups are as similar as possible
in terms of their age, gender, other health problems,
all those other factors that might change
how they respond to the drug.
So it's like you're trying to make sure
that the only difference is the drug.
Exactly.
And not some other hidden thing.
(10:01):
And these ideas about minimizing bias,
they apply to everything in the trial.
Not just how we treat the patients,
but how we collect the data, how we analyze it,
even how we report the results.
Everything has to be done super carefully and openly.
This is a lot.
It is.
How do researchers keep track of all this?
And that's where the ICH guidelines come in.
(10:23):
Remember, they cover pretty much everything
about clinical trials.
From the very beginning to the final report.
They give us a structure for doing the research,
ethically and reliably.
So doctors and regulators all over the world
can trust the results.
So it's like an instruction manual
for doing a clinical trial the right way.
Yeah, think of it like that.
(10:43):
Make sure that it's consistent and good quality,
no matter who's doing it or where they are in the world.
But it's not just about following the rules.
Right.
Researchers also have to be flexible
and change things up when they need to.
Okay.
You know, they always have to look at the data
and maybe tweak the design of the trial.
So there's a human element too.
Absolutely.
It's not just plugging numbers into a formula.
(11:04):
No, it's about people.
Right.
It's about the patients who volunteer their time
and even their bodies to help us learn more.
Right.
It's about researchers who spend their whole lives
trying to find better treatments.
Yeah.
And regulators who are always working
to make sure those treatments are safe and actually work.
It reminds you that science is about people.
(11:24):
It is.
And curiosity and wanting to help others
and make things better.
Absolutely.
And speaking of making things better,
let's talk about something
that doesn't always get enough attention.
Okay.
Pharmacovigilance.
Okay.
Remember how we talked about how things don't just stop
when a drug is approved?
Yeah, post-market surveillance.
Yes.
It's like you keep watching the drug
(11:46):
even when it's out in the real world.
That's exactly what pharmacovigilance is.
It's all about watching to make sure the drugs are safe.
Okay.
Once lots of people are using them.
Yeah, okay.
This is a super important step.
Right.
Because sometimes those rare side effects,
they don't show up until millions of people
are taking the drugs.
So it's like a safety net.
Yeah.
Catching any problems that might have slipped through earlier.
(12:08):
Exactly.
During the trials.
And the ICH guidelines are important here too.
Right.
They give us a way to collect and look at
and report that safety data.
Okay.
From all over the world.
So it's like we have eyes and ears everywhere.
Yeah.
Constantly watching for any signs
that something might be wrong with a drug.
So everyone's working together.
Yes.
Researchers, doctors, regulators,
(12:28):
even the patients themselves.
Exactly.
We all play a role in keeping drugs safe.
And that's something we're gonna explore next time.
Okay.
As we dive deeper into pharmacovigilance.
Okay.
And we'll talk about how these safety monitoring systems
really work.
Cool.
But for now, let's just think about how complex
and important clinical trials are.
They are the foundation of evidence-based medicine.
(12:50):
Yeah.
They give us the data we need to decide
which treatments are safe and effective.
Welcome back to the Deep Dive.
We've come a long way.
From a scientist idea for a new drug,
all the way through those intense clinical trials.
Yeah.
And it's pretty incredible to see the work
that goes into making sure those trials are done right,
(13:11):
you know, with real scientific integrity.
It is.
And now we're talking about post-market surveillance,
keeping an eye on the drug after it's been approved,
and out there for everyone to use.
Exactly.
And as we've learned,
even with all the tests and analysis that we do,
sometimes those really rare side effects,
or maybe things that only happen over a long period of time,
(13:31):
they don't always show up
until a lot more people are using the drug.
It makes you think, how do we balance that need
to get lifesaving treatments out to people quickly,
especially for serious diseases,
with making absolutely sure that they're safe?
Yeah.
Seems like a tough balance.
It is a very delicate balancing act.
You know, on the one hand,
we have patients and their families
(13:53):
who are really hoping for new treatments,
especially for conditions
where there aren't a lot of options right now.
Right.
And the need to find something that works,
something that helps people feel better
and improves their quality of life is huge.
But we've also seen what can happen
when drugs are rushed through development
without enough testing.
Like the thalidomide tragedy.
(14:14):
Right.
It's a stark reminder that safety
has to be our top priority.
Absolutely.
The thalidomide case where a drug
meant to help with morning sickness
ended up causing birth defects.
That was tragic.
And it shows what can happen when we move too fast
and don't do things carefully.
It's a lesson that doctors and regulators,
like the FDA, have really learned from,
which is why we have all these strict safety rules today.
(14:37):
So how do we deal with this tension
between speed and safety?
Can we speed things up without cutting corners?
There are ways,
and the FDA has some programs do just that.
For example, there are the Fast Track
and Breakthrough Therapy designations.
These allow for faster review of drugs
that look promising for treating serious
or life-threatening conditions.
This is like a fast-forward button
(14:58):
for certain parts of the approval process.
Exactly.
But it's really important to understand
that even with these faster programs,
safety is still the most important thing.
Right.
The FDA still needs a lot of testing and evaluation.
The timeline is just shorter for the review
and making decisions.
I see how that would give hope
to people with serious illnesses,
(15:19):
especially when time is really important.
But I imagine some people worry
that these faster pathways could make things less safe.
That's a valid concern,
and it's something people talk about a lot.
The key is to find a balance to streamline things
when we can without sacrificing
the careful scientific work.
Right.
And that's where those ICH guidelines
we keep talking about are so important.
(15:40):
Right.
They help to make sure that the information gathered
during these faster trials is still good
and meets the highest standards.
So it's not just about speed.
It's about keeping the data reliable
and being transparent about the process.
Exactly.
And transparency is key,
not just for scientists and regulators,
but for patients too.
They need clear and accurate information
(16:00):
about the possible benefits and risks
of any new treatment,
especially when those treatments
have gone through these faster pathways.
It's all about trust.
Yeah.
Patients need to trust that the medicines they're taking
have been carefully looked at
and that the people making decisions
about whether to approve new drugs
are really putting patients' needs first.
Couldn't have said it better myself.
(16:22):
And to build that trust,
we need open communication and collaboration
between everyone.
Right.
The regulatory agencies,
the pharmaceutical industry,
the researchers, the healthcare providers,
and especially the patients themselves.
Right.
They need to be heard throughout the entire process
from designing the trials
to making sure the drug is safe in the long run.
It's a good reminder that drug development
(16:43):
isn't just about science and regulations,
it's about people.
And it's something that we have to be constantly
paying attention to and adapting
as we learn more about how these medicines
work in our bodies.
Exactly.
It's a journey that goes on
even after the FDA gives its approval.
And post-market surveillance is a crucial part
of making sure drugs are safe.
Think of it like a conversation
(17:05):
between science and society,
where we are always trying to balance
the potential of new treatments
with the absolute need to keep patients safe.
I like that.
Well said.
It looks like we've come full circle
in our deep dive into drug development.
We've seen how preclinical research works.
We've explored the steps in clinical trials.
And we've talked about the importance
(17:26):
of post-market surveillance.
We hope you've gotten a better understanding
of this whole process.
Yeah.
And that you'll keep learning and asking questions
about the medicines that affect your health.
Thank you for joining us on the deep dive.
Until next time, keep exploring, keep learning,
and keep asking those important questions.
Welcome to the deep dive.
(00:02):
We're gonna be looking at something that affect all of us
over the next few episodes, and that is drug development.
It's a really long and complicated journey,
but we're gonna be using a spiral learning approach.
We can kind of break it down into these smaller pieces,
adding details, we kind of circle back.
Think of it like exploring a city.
(00:22):
First you get like a lay of the land from above,
and then you start zooming in on the streets
and the neighborhoods.
That's a great analogy.
And just like a city, there's always new stuff to discover
in drug development.
Right.
So we'll start today by mapping out those major phases.
So that's preclinical research, the clinical trials,
and finally post-marketing surveillance.
We're also gonna look at like the role of the FDA
(00:43):
and the ICH guidelines.
Okay.
See how they help to make sure that new drugs
are effective and safe for everyone.
So let's say like a new cholesterol drug
is making headlines.
What happened before it ended up on the pharmacy shelves?
Years of work for sure.
It all starts with that preclinical research.
That's where scientists are testing thousands
of potential compounds in the lab.
(01:04):
Okay.
And they might start with just a hunch about what might work.
They might even use computer modeling to design molecules.
It's almost like cracking a code.
They're looking for that perfect combination
that targets the disease without causing bad side effects.
So it's not just like mixing random chemicals together?
No, no.
There's a lot of strategy involved.
Absolutely, a lot of trial and error too.
(01:26):
Okay.
During preclinical, they're looking at how the drug
behaves in cells in animals,
how it's absorbed broken down by the body,
and of course its potential toxicity.
Okay.
So it's about getting enough evidence to move from
this might work to we can test this in humans.
Okay, so that brings us to clinical trials.
(01:47):
Yeah.
I always thought it was just one thing,
but it turns out there are multiple phases.
You got it.
We're gonna add another layer to phase zero.
Phase zero.
Okay.
So it's a really quick peek inside the human body.
We're talking a tiny dose to a few people,
not even enough to treat anything,
but just enough to see if the drug is behaving as expected.
Like does it reach the target?
(02:08):
How long does it stay in the system?
Okay.
It's all about confirming those assumptions
before we do larger trials.
It's a kind of like a dress rehearsal.
Perfect way to put it.
Then we go to phase one, which is all about safety.
A small group of healthy volunteers gets different doses.
Researchers are carefully watching for side effects,
figuring out a safe dose range,
(02:29):
and they're gathering information
about how the drug is interacting with the body.
So if you volunteer for a phase one trial,
you're really on the front lines of research.
That's right.
And without these brave volunteers,
we wouldn't be able to move forward.
But even if the drug gets through phase one,
it's still a long way to approval.
Right.
In phase two, we finally start to include patients
who have the condition we wanna treat.
(02:51):
This phase is still about safety,
but we are also starting to look at efficacy.
Does it actually work?
Can we measure a positive effect
in the people taking it compared to those who aren't?
So this is where we start seeing if the drug
actually works in the real world.
Exactly.
And if the results in phase two are promising,
we move to the big leagues phase three.
(03:12):
Oh, wow.
These are large scale trials,
sometimes thousands of patients,
all across multiple countries.
Wow.
Here we're confirming that the drug is effective,
the monitoring for rare side effects
that may not have shown up earlier,
and also comparing it to the treatments
that are already out there.
So this is where those ICH guidelines
that we mentioned come in.
Yeah.
(03:32):
It's like a rule book for these large trials, right?
You got it.
Ensures consistency and reliable research
no matter where it's happening.
The ICH or International Council for Harmonization,
it's basically a global team of regulators
and experts and pharmaceuticals
working to streamline drug development.
Okay.
Think about it.
Without these guidelines, companies would have to do
totally different trials for every single country
(03:55):
that they wanna sell their drug in.
That would be super expensive, time consuming,
and it could delay like life-saving treatments for years.
Wow.
So these guidelines really make sure
that new medicines reach patients safely and quickly.
Absolutely.
It's not just about the science either.
They also think about things like ethical considerations,
data collection, and even how the results are reported.
(04:18):
It's all about transparency and accountability
the whole way through.
Okay, so let's say that our cholesterol drug
has passed these three phases with flying colors.
Is it ready for prime time?
Not quite.
This is where the FDA steps in.
Okay.
They look at all the data from those preclinical
and clinical trials, assess the drug's safety,
its efficacy, its manufacturing process.
(04:39):
Okay.
It's a rigorous process, and it should be,
we're talking about giving this drug potentially
to millions of people.
So the FDA is like the last checkpoint.
Precisely.
Making sure everything is good
before it can be sold in the US.
Exactly.
And if the FDA gives it the thumbs up,
our cholesterol drug finally hits the market.
Okay.
But it still doesn't end there.
Oh, there's more.
(04:59):
I thought approval was the finish line.
It's more like a new starting line.
Okay.
Now we enter post-marketing surveillance.
So now the drug is used by a much wider group of people
than in the clinical trials.
Right.
This is how we find any very rare side effects
that didn't show up before.
And we can also see how well it works long-term
out in the real world.
So it's a process of always learning and refining
(05:21):
even after it's available to everyone.
Exactly.
The FDA is still involved too.
They monitor safety reports and evaluate new data.
Right.
They might even require more studies if they have to.
Wow.
It shows that drug development is always changing.
We're always learning new things
about how these medicines interact with our bodies.
This is all fascinating, but I have to admit,
(05:42):
I'm a little lost in all the phases and regulations.
I hear you.
It is a lot to take in, especially for our first dive.
But remember, we are taking that spiral learning approach.
So we'll keep coming back to these concepts
and adding new information each time.
That makes me feel better.
I am starting to see the big picture
and I'm ready to go deeper into these specific things
(06:02):
in our future episodes.
Me too.
But for now, let's just think about
how much goes into getting one single drug from the lab
to your medicine cabinet.
Right.
A real testament to human ingenuity, to science,
and to this commitment to making sure patients are safe.
I like that.
Beautifully said.
Thanks.
And on that note, we'll wrap up part one of our deep dive.
(06:25):
Join us next time as we get into those clinical trials.
Explore the world of study design control groups
and how we make sure there's no bias
so we can get the best results.
Sounds good.
Welcome back to the deep dive.
Last time we talked about,
you know how a potential drug goes from the lab
all the way to the pharmacy shelf,
passing through all that preclinical testing,
(06:46):
the phases of clinical trials.
It was amazing to think about all the steps.
And you mentioned the ICH guidelines.
So they make sure the trials are done consistently
across all the different countries.
It's like having a universal language
for doing medical research.
Exactly, making sure the quality and the reliability
is there no matter where the research is being done.
But let's zoom in on the clinical trials themselves today,
(07:09):
specifically how they're designed to minimize bias
and give us the most accurate picture
of whether a drug really works or not.
Okay, because I remember you talk about control groups.
Yes.
Why are they so important?
So imagine like you're trying a new workout routine
to let's say get stronger.
(07:30):
You go to the gym three times a week,
you do all the exercises,
and then after a month you feel stronger.
But how do you know for sure
if it was the routine that made that difference?
Maybe you were also getting more sleep
or you were eating healthier.
Or maybe you were just getting stronger naturally
because you're going to the gym more.
Right, you need something to compare it to.
Yeah, like a baseline.
In drug trials, the control group gives us that baseline.
(07:54):
So let's say we're testing a new pain reliever.
One group gets the actual drug
while the control group might get a placebo.
So it looks the same,
but it doesn't have any of the active ingredients.
Right, so like a sugar pill.
Exactly, so that way we can see
what the effect of the drug is.
Separate from other things
that might be making people feel different.
Wow, that's pretty clever.
(08:15):
But what about when you're comparing a new drug
to one that's already out there?
Uh huh, yeah.
You know, for the same condition.
That's called an active control group.
That's really important for figuring out
if a new drug is better than what we've already got.
Is it more effective?
Does it have less side effects?
Is it easier to take?
These are the questions we gotta answer
before we say, hey everybody go use this new treatment.
(08:37):
So picking the right kind of control group
is really important for getting good results.
Yes, very important.
You also talked about bias.
Yes.
Isn't science already objective?
It should be.
Right.
But bias can sneak into research
even when we don't mean for it to.
Let's say I'm a researcher who is super excited
about this new pain reliever I'm testing.
(08:59):
Right.
I might, without even realizing it,
treat the patients getting the real drug
differently from those who are getting the placebo.
Oh, okay.
Maybe I encourage them more
or I watch their symptoms more closely.
Right, so even little differences in how you treat people
can change how they respond.
Exactly, and that can mess up the results.
And that's why they do blinding in clinical trials.
(09:20):
You got it.
So that means neither the patients nor the researchers
know who is getting the real drug.
It's like a double blind taste test.
Right, you get a more honest opinion.
Exactly.
If you don't know what you're tasting.
Exactly.
Are there any other ways to minimize bias?
Absolutely, randomization.
Instead of the researchers choosing who goes in each group,
(09:41):
patients are assigned randomly, like flipping a coin.
This helps make sure both groups are as similar as possible
in terms of their age, gender, other health problems,
all those other factors that might change
how they respond to the drug.
So it's like you're trying to make sure
that the only difference is the drug.
Exactly.
And not some other hidden thing.
(10:01):
And these ideas about minimizing bias,
they apply to everything in the trial.
Not just how we treat the patients,
but how we collect the data, how we analyze it,
even how we report the results.
Everything has to be done super carefully and openly.
This is a lot.
It is.
How do researchers keep track of all this?
And that's where the ICH guidelines come in.
(10:23):
Remember, they cover pretty much everything
about clinical trials.
From the very beginning to the final report.
They give us a structure for doing the research,
ethically and reliably.
So doctors and regulators all over the world
can trust the results.
So it's like an instruction manual
for doing a clinical trial the right way.
Yeah, think of it like that.
(10:43):
Make sure that it's consistent and good quality,
no matter who's doing it or where they are in the world.
But it's not just about following the rules.
Right.
Researchers also have to be flexible
and change things up when they need to.
Okay.
You know, they always have to look at the data
and maybe tweak the design of the trial.
So there's a human element too.
Absolutely.
It's not just plugging numbers into a formula.
(11:04):
No, it's about people.
Right.
It's about the patients who volunteer their time
and even their bodies to help us learn more.
Right.
It's about researchers who spend their whole lives
trying to find better treatments.
Yeah.
And regulators who are always working
to make sure those treatments are safe and actually work.
It reminds you that science is about people.
(11:24):
It is.
And curiosity and wanting to help others
and make things better.
Absolutely.
And speaking of making things better,
let's talk about something
that doesn't always get enough attention.
Okay.
Pharmacovigilance.
Okay.
Remember how we talked about how things don't just stop
when a drug is approved?
Yeah, post-market surveillance.
Yes.
It's like you keep watching the drug
(11:46):
even when it's out in the real world.
That's exactly what pharmacovigilance is.
It's all about watching to make sure the drugs are safe.
Okay.
Once lots of people are using them.
Yeah, okay.
This is a super important step.
Right.
Because sometimes those rare side effects,
they don't show up until millions of people
are taking the drugs.
So it's like a safety net.
Yeah.
Catching any problems that might have slipped through earlier.
(12:08):
Exactly.
During the trials.
And the ICH guidelines are important here too.
Right.
They give us a way to collect and look at
and report that safety data.
Okay.
From all over the world.
So it's like we have eyes and ears everywhere.
Yeah.
Constantly watching for any signs
that something might be wrong with a drug.
So everyone's working together.
Yes.
Researchers, doctors, regulators,
(12:28):
even the patients themselves.
Exactly.
We all play a role in keeping drugs safe.
And that's something we're gonna explore next time.
Okay.
As we dive deeper into pharmacovigilance.
Okay.
And we'll talk about how these safety monitoring systems
really work.
Cool.
But for now, let's just think about how complex
and important clinical trials are.
They are the foundation of evidence-based medicine.
(12:50):
Yeah.
They give us the data we need to decide
which treatments are safe and effective.
Welcome back to the Deep Dive.
We've come a long way.
From a scientist idea for a new drug,
all the way through those intense clinical trials.
Yeah.
And it's pretty incredible to see the work
that goes into making sure those trials are done right,
(13:11):
you know, with real scientific integrity.
It is.
And now we're talking about post-market surveillance,
keeping an eye on the drug after it's been approved,
and out there for everyone to use.
Exactly.
And as we've learned,
even with all the tests and analysis that we do,
sometimes those really rare side effects,
or maybe things that only happen over a long period of time,
(13:31):
they don't always show up
until a lot more people are using the drug.
It makes you think, how do we balance that need
to get lifesaving treatments out to people quickly,
especially for serious diseases,
with making absolutely sure that they're safe?
Yeah.
Seems like a tough balance.
It is a very delicate balancing act.
You know, on the one hand,
we have patients and their families
(13:53):
who are really hoping for new treatments,
especially for conditions
where there aren't a lot of options right now.
Right.
And the need to find something that works,
something that helps people feel better
and improves their quality of life is huge.
But we've also seen what can happen
when drugs are rushed through development
without enough testing.
Like the thalidomide tragedy.
(14:14):
Right.
It's a stark reminder that safety
has to be our top priority.
Absolutely.
The thalidomide case where a drug
meant to help with morning sickness
ended up causing birth defects.
That was tragic.
And it shows what can happen when we move too fast
and don't do things carefully.
It's a lesson that doctors and regulators,
like the FDA, have really learned from,
which is why we have all these strict safety rules today.
(14:37):
So how do we deal with this tension
between speed and safety?
Can we speed things up without cutting corners?
There are ways,
and the FDA has some programs do just that.
For example, there are the Fast Track
and Breakthrough Therapy designations.
These allow for faster review of drugs
that look promising for treating serious
or life-threatening conditions.
This is like a fast-forward button
(14:58):
for certain parts of the approval process.
Exactly.
But it's really important to understand
that even with these faster programs,
safety is still the most important thing.
Right.
The FDA still needs a lot of testing and evaluation.
The timeline is just shorter for the review
and making decisions.
I see how that would give hope
to people with serious illnesses,
(15:19):
especially when time is really important.
But I imagine some people worry
that these faster pathways could make things less safe.
That's a valid concern,
and it's something people talk about a lot.
The key is to find a balance to streamline things
when we can without sacrificing
the careful scientific work.
Right.
And that's where those ICH guidelines
we keep talking about are so important.
(15:40):
Right.
They help to make sure that the information gathered
during these faster trials is still good
and meets the highest standards.
So it's not just about speed.
It's about keeping the data reliable
and being transparent about the process.
Exactly.
And transparency is key,
not just for scientists and regulators,
but for patients too.
They need clear and accurate information
(16:00):
about the possible benefits and risks
of any new treatment,
especially when those treatments
have gone through these faster pathways.
It's all about trust.
Yeah.
Patients need to trust that the medicines they're taking
have been carefully looked at
and that the people making decisions
about whether to approve new drugs
are really putting patients' needs first.
Couldn't have said it better myself.
(16:22):
And to build that trust,
we need open communication and collaboration
between everyone.
Right.
The regulatory agencies,
the pharmaceutical industry,
the researchers, the healthcare providers,
and especially the patients themselves.
Right.
They need to be heard throughout the entire process
from designing the trials
to making sure the drug is safe in the long run.
It's a good reminder that drug development
(16:43):
isn't just about science and regulations,
it's about people.
And it's something that we have to be constantly
paying attention to and adapting
as we learn more about how these medicines
work in our bodies.
Exactly.
It's a journey that goes on
even after the FDA gives its approval.
And post-market surveillance is a crucial part
of making sure drugs are safe.
Think of it like a conversation
(17:05):
between science and society,
where we are always trying to balance
the potential of new treatments
with the absolute need to keep patients safe.
I like that.
Well said.
It looks like we've come full circle
in our deep dive into drug development.
We've seen how preclinical research works.
We've explored the steps in clinical trials.
And we've talked about the importance
(17:26):
of post-market surveillance.
We hope you've gotten a better understanding
of this whole process.
Yeah.
And that you'll keep learning and asking questions
about the medicines that affect your health.
Thank you for joining us on the deep dive.
Until next time, keep exploring, keep learning,
and keep asking those important questions.
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