Clinical Trial Podcast | Conversations with Clinical Research Experts

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 Nucleus Network . Dr. Wood is a leader in the conduct and design of clinical...

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, imaging data collection process, and more. The guest for today's show is a long t...

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? To answer these questions and more, I invited Darshan Kulkarni to the show. Darshan is...

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 launch an NIH funded research project?" To answer this question, I invited Dr. Manish Shah,  Professor of Pediatrics...

There is more to the world of clinical data management than building and cleaning databases.  Did you know you can leverage your clinical data for clinical operational excellence across your organization? To educate us on the nuts and bolts of clinical data management and how data can guide us with our clinical operations decision making, I invited Mariam Mirgoli, Vice President of Clinical Data M...

A big part of managing clinical research at any site is managing clinical research billing. If you don't keep track of your research finances, it can end up costing you a lot of money in the long run.  To understand clinical research billing, how to manage billing activities, the role of a clinical trial management system (CTMS), differences between cash and accrual based accounting, and more,  I...

One of the most time and resource intensive tasks in clinical research is data entry.  Clinical research coordinators spend countless hours transferring clinical data from a patient's Electronic Health Record (EHR) into a study specific Electronic Data Capture (EDC) system.  This is annoying because the research coordinator could instead spend those hours on recruiting patients.  A direct EHR to E...

As the clinical research ecosystem becomes more site and patient centric, I was curious about what an ideal software stack looks like for clinical research sites. It goes without saying you need a laptop and stable internet connection to do business in this day and age. But what else do you need to keep yourself organized as a clinical research site?  How can a clinical trial site bring most value...

Dr. Bierer is the Director of the Regulatory Foundations, Ethics and the Law Program of the Harvard Clinical and Translational Science Center and the Director of Regulatory Policy, SMART IRB.  Previously she served as senior vice president, research, at the Brigham and Women's Hospital for 11 years, and was the institutional official for human and animal research, for biosafety, and for research i...

This podcast episode highlights the top reasons for patient recruitment failure in clinical trials from an investigator perspective.   The podcast episode will help you understand how Sponsor and CRO personnel including software vendors can best support investigators meet or exceed their patient recruitment.    The goal is to bring more awareness on how to prevent patient recruitment failure and c...

Clinical trials are conducted in compliance with regulations.  Simply stated, you need a clinical and regulatory strategy when it comes to conduct of clinical trials for medical devices. As a clinical researcher, there have been times I've felt lost because I did not understand the regulatory framework. To close this knowledge gap, I thought it would be great to invite Priya Jagasia, Divisional Vi...

The pandemic has helped fast track the adoption of technology in clinical research. This has been a much needed change and we're headed in the right direction.  The change in turn has led to an increased focus on decentralized clinical trials (DCTs).  But what exactly is a DCT?  To learn more, I invited Derk Arts, Founder & CEO of Castor.  Derk has over fifteen years of experience in medicine, res...

My guest for this interview is Rebecca Matthews, Chief Clinical Operations Officer at Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation. In this interview, Rebecca shares with us what it takes to conduct clinical trials investigating the use of MDMA, a psychedelic drug, in conjunction with psychotherapy to treat patients with post traumatic stress disorder (PT...

Do you want to enroll a diverse patient population in your clinical trial?  Are you a sponsor looking to develop a solid clinical trial strategy? Are you looking to develop foundational skills as a clinical research scientist? If you answered "Yes" to any of these questions, then this interview with Jennifer Jones-McMeans will serve you well. Jenn currently serves as the Program Director for cardi...

One of the biggest challenges in clinical study start-up and conduct is "training." A few factors that impact training include the clinical site personnel's ability to retain and understand key study information, staff turnover at the site, individual learning style and preferences and much more.  With many clinical research and trial activities going virtual, having an online platform to train re...

Many people tout about technical skills in clinical research. You need to know Microsoft Excel. You need to understand Good Clinical Practice. You need to memorize the FDA guidance documents. Have you ever heard someone talk about soft skills in clinical research? I realized the importance of soft skills after joining Abbott in 2007 as a Clinical Project Manager. When you work with a diverse team,...

In this episode, I had an opportunity to speak with Maha Dakhloul on the topic of Patient Support Programs (PSPs) in the Middle East and North Africa (MENA region). Maha does a great job of explaining with us how PSPs are set-up, how one can develop a PSP, the lesser known components of a PSP, how to measure a successful PSP, how to evaluate a PSP provider, the interdependence of clinical trials a...

Starting a career in clinical research with little or no experience can be difficult. Equally challenging is for hiring managers to find candidates that are a cultural fit for the organization. In this interview, I invited my close friend and mentor Chris Lewis to talk about his process of attracting, hiring, and retaining talent in clinical research.  We talked about the future of the CRA role an...

I'm always excited to speak with software entrepreneurs in clinical research and this episode is no excpetion. Our guest on today's show is Maya Zlatanova, CEO of FindMeCure.  Maya and her team are creating a "google" for clinical trials.  She is on a mission to make it easy for patients to find ongoing clinical trials She wants to solve patient recruitment challenges enabling patients and doctors...

Clinical trial finance is a key area of clinical trials and clinical research.  Human beings are innately not good with numbers and clinical trial finance is no exception.  Creating study budgets, forecasting clinical trial costs, and managing trial finances are essential skills for any clinical research professional.  This is true for sites, vendors, CROs, and Sponsor personnel, irrespective of w...

Today we're in the midst of the pandemic and virtual clinical trials are likely going to be a big part of our post-COVID-19 world.  In this interview, I had the pleasure of speaking with Mike Novotny about virtual trials i.e. decentralized trials.  Mike is the founder and CEO of Medrio . Mikes brings over 20 years of experience in research and software to his eClinical SaaS vision.  Prior to found...

In this interview, I had the opportunity to speak with Ahmed Hamouda.  Ahmed is the Head of Clinical Operations at RAY-CRO in Egypt and a certified clinical research professional with more than 10 years of experience within the clinical research field. I've been intrigued and fascinated by the Middle East and have wondered how trials are conducted in the region.  If you've been site and country se...

Ravi Shankar is the founder of FCE Source, a boutique CRO that serves as a strategic partner to medical device companies looking for field clinical engineering support. FCE, which stands for Field Clinical Engineer, is a specialized role that specifically serves medical device trials.  FCE is a medical device expert who knows exactly how the medical product needs to be used in the medical setting....