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 Administration for over ten years, spending time as a scientific and regulatory reviewer, a chief of the Diabetes Diagnostic Devices Branch, and Deputy Office Director of Personalized Medicine and Molec ..read more

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​-​House​ ​is​ ​co​-​chair ​of​ ​the​ ​Working​ ​Group​ ​on Compassionate​ ​Use​ ​and​ ​Preapproval​ ​Access​ (​CUPA​), ​an​ ​academic group​ ​that​ ​studies​ ​ethical issues concerning access ..read more

A clinical trial newsletter is a low tech tool that can help you drive site engagement.  Here is 5 content ideas for your next clinical trial newsletter: Recognize clinical trial sites for their contributions Mention names of Investigator and Clinical Research Coordinators (CRCs) who have made meaningful contributions towards patient recruitment or collecting high quality, clinical data. Public recognition goes a long way! Add a photo (or two). It helps your newsletter become more human! With travel back in full swing, there are plenty of opportunities to get photos during site initia ..read more

The FDA wants pharmaceutical and medical device manufacturers to enroll diverse patients in clinical trials.  One way to achieve the diversity goal is to engage with physicians in the community and provide them with the resources and support to conduct clinical trials. 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 ..read more

During a dinner conversation with a colleague last week, I was reflecting on why clinical trials were so complicated. It all boils down to three reasons: Human Motivation  Many of us (including myself) underestimate human psychology and motivation.  At an individual level, each of us is motivated by different things (status, money, freedom, etc.)  At a macro level, private for-profit organizations want to maximize profits (think CROs, biopharmaceutical and medical devices companies), non-profit organizations want to achieve their mission (think large academic sites), or the gove ..read more

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 organizations in the United States with more than 40 acute care, managed, and specialty hospitals, convenient urgent care locations, imaging centers and pharmacies. In 2022, over 38,000 Mercy patients ..read more

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.  To learn about Postmarket Surveillance Studies regulatory requirements, process for collecting clinical data for such studies, key elements of PMS plan, and more, I invited Dr. David Rutledge on the podcast. David is the President & CEO at Global Strategic Solutions, where he works as a ..read more

In this episode, we will explore the role of design in clinical trials, with a focus on electronic Patient Reported Outcome (ePROs). Most clinical research professionals are so focused on protocol development, 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 completed by clinical trial participants as part of the study requirements.  To learn more about ePROs and the role of design in cli ..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. At NuPulse, Sonna is responsible for developing and executing on strategic initiatives for the company, building a diverse and multidisciplinary team of engineers, regulatory and quality associates, marketing, manufacturing, clinical ..read more

Our guest today is Bijan Elahi, where we talk about risk management for clinical investigators conducting medical device clinical trials. In this episode, you’ll be introduced to ISO 14971 Application of risk management to medical devices and learn about its relationship to ISO 14155 Clinical investigation of medical devices for human subjects — Good Clinical Practice. You’ll also understand key terminology around risks, how to define risk, what’s special about clinical studies with respect to risk management, and much more. Bijan has worked in risk management for medical devices for over 29 ..read more