Clinical Trial Podcast | Conversations with Clinical Research Experts
Clinical research and clinical trial management form the backbone of drug and device approvals worldwide. Learn from the leading industry experts to build and advance your clinical research career. You'll hear from sponsors, clinical research organizations, and clinical trial sites around the globe. This show is for all current and aspiring clinical research professionals including clinical research associates (CRA), clinical operations managers, study managers, biostatisticians, medical doctors, safety monitors, clinical scientists and other healthcare professionals. To learn more, visit https://clinicaltrialpodcast.com/
Episodes
To learn more about clinical trials in diabetes, I invited Dr. Stayce Beck, Global Vice President of Clinical Affairs at Dexcom Inc. on the podcast.
Dr. Beck currently oversees clinical operations, clinical strategy and science, biometrics and human factors at Dexcom Inc, a leading manufacturer of continuous glucose monitors (CGMs)
Prior to joining Dexcom, Dr. Beck worked at Food and Drug Adm...
Providing patients access to novel medical products can be challenging to navigate for sponsors and trial participants alike.
To learn more about expanded access, compassionate use, Right to Try laws, I invited Dr. Alison Bateman-House, PhD, MPH, MA, an Assistant Professor in the Division of Medical Ethics at NYU Grossman School of Medicine.
Dr. Bateman...
Unlike an electrical engineer or a plumber, clinical research roles are not explicitly defined or categorized as such, in government employment databases.
There are no certification or degree requirements to work as a clinical research professional either.
To explore the topic of clinical research as a profession, I invited Erike Stevens on the podcast.
Erika advises life sciences...
To learn about community engagement in clinical trials, what it means, recent regulations and guidance documents, I invited Chris Komelasky, CEO and Co-founder of SiteBridge Research, on the podcast.
SiteBridge Research is an Integrated Research Organization (IRO). Chris and his team help connect physicians and their patients to clinical trials and facilitate the process by reducing barriers for sites and...
Community health system-based research continues to become an important focus area for pharmaceutical and medical device sponsors given the recent FDA guidance on diversity in clinical trials.
Our guest for this episode is JoAnne Levy, Vice President at Mercy Research, a part of Mercyhealth.
Mercy Research is one of the largest fully integrated, community health system-based research organiz...
In this episode, we’re going to talk about Postmarket Surveillance Studies.
In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies.
The importance of such studies has grown in recent years as regulators want to know about the safe...
In this episode, we explore the role of design in clinical trials.
Most clinical research professionals are so focused on protocol design, data collection, and analysis that it’s easy to overlook the importance of well-designed technology that supports clinical trials.
One such technology product is electronic Patient Reported Outcomes or ePROs. ePROs are surveys that are presented to and comp...
There are advantages and disadvantages when it comes to being a standalone clinical trial site.
Standalone clinical trial sites enjoy the freedom of running their own operations. But they may face challenges with executing some parts of a clinical trial.
This is where site networks come in.
Read more
In this episode, I’m excited for you to learn about Heart Failure Clinical Trials for medical devices.
Our guest today is Sonna Patel-Raman. Sonna is currently the President at NuPulse Inc, an early stage medical device company responsible for developing the first minimally invasive, long-term, ambulatory counterpulsation device that works in sync with the heart...
To learn more about site reads and the role of medical imaging software, I invited Kelie Williams Luby, Vice President of Clinical Trials at Mint Medical.
Kelie has 24 years of experience as a clinical trial researcher, first as a medicinal chemist, and for the past 19 years as a clinical trialist in medical imaging-based endpoints. Read more
This is a special episode on risk management. It is important to understand what dictates the work we do as clinical research professionals and how our work fits into the bigger picture of medical product development. This episode serves exactly that purpose.
You’ll be introduced to I...
In this episode, I’m excited to share with you 5 Strategies for planning and conducting investigator and steering committee meetings. Now that the world is starting to re-open after the COVID-19 pandemic, more sponsors are conducting in-person meetings with key opinion leaders (KOLs).
T Read more
When a new drug or device undergoes “first in human” experience, the primary focus is on participant safety. How will the drug or device interact with the human body? And will this interaction be safe?
To answer these two questions, regulatory authorities around the world require medic...
Phase I trials are generally conducted in healthy participants or in patients with no treatment options such as oncology patients.
Unlike late phase trials, Phase I (also known as early phase) studies have different patient recruitment challenges.
To learn more, I invited Dr. Graham Wood, Executive Vice President, USA at
Medical Imaging in Clinical Trials with Elizabeth Dalton
In this episode, I’m excited to talk about medical imaging in clinical trials.
We’ll discuss the role of a medical imaging CRO, imaging endpoints in clinical trials, expensive mistakes to avoid as a trial Sponsor/ CRO, saving money on medical imaging services, imagin...
Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials?
What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinical trial results with patients?
Should a Sponsor get access to patient data collected outside a clinical trial setting?
In the fiscal year 2021, the National Institute of Health (NIH) funded only 16,959 out of 80,878 research project grants.
In other words, the success rate was 21%.
And the total funding amount was $8,827,444,624.
The question I had was, “What does it take to get grant approval and lau...
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