Clinical Trial Podcast | Conversations with Clinical Research Experts

“You have to forgive yourself and not expect perfection” - Robin Eckert In this episode, I had the privilege to talk to Robin Eckert. Robin is an engineer by training who later transitioned into clinical safety and clinical trial management. She is a very accomplished individual who has led complex structural heart medical device trials. Robin is also one of the most creative individuals in the clinical research space. If you’re a gal (or a guy) wanting to transition into clinical research or change roles at your current company, Robin will inspire you with her personal story. We wrap up our discussion with top-notch resources in the interventional cardiology space. I hope you enjoy this interview with Robin as much as I did. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.” Selected Links from the Episode Connect with Robin LinkedIn TVT Conference TCT MD FDA Resources Drugs Medical Devices Biologics Gray Sheet Cardiac Interventions Today Graphics Design: 99Designs Show Notes: Transitioning from R&D engineering to clinical research [02:39] Leading clinical safety and working independently [10:50] What it takes to switch roles [13:41] Finding mentors within clinical organization [16:08] Creativity in clinical research [19:01] Importance of marketing and messaging in clinical research [23:19] Tips and insights for CROs responsible for creating newsletters [29:18] How to get credibility among your peers, industry, understanding why something is important in the grand scheme of things [35:25] Attending conferences [37:27] QUESTION: What was most useful for you in this episode? Leave me a comment below and thanks for listening.

“Don’t be afraid to try new things” - James Hasegawa This is a special episode in Health Economics and Outcomes Research (HEOR) with James Hasegawa. James is a director at Abbott and is responsible for HEOR projects. In this episode, James shares insights on how healthcare reimbursement works as it related to clinical trials. We also dig into the world of Health Technology Assessment (HTA) groups and what it takes to model reimbursement for a medical product. If you’re interested in breaking from the silos of clinical research and learn about important adjacent functions such as HEOR, this episode is for you. Do you have a topic idea for my next podcast episode? If so, leave me your suggestion is the comments section below. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.” Selected Links from the Episode Connect with James LinkedIn Medicare International Society for Pharmacoeconomics and Outcomes Research (IPSOR) BIO conference Stanford Biodesign Program Centre for Health Economics at University of York The National Institute for Health and Care Excellence (NICE) What is a MAC? Hospital Readmissions Reduction Program Books Mentioned: Leading at Mach 2 by Steve Sullivan Good to Great by Jim Collins The Tipping Point: How Little Things Can Make a Big Difference by Malcolm Gladwell Biodesign: The Process of Innovating Medical Technologies by Paul G. Yock and Stefanos Zenios Methods for the Economic Evaluation of Health Care Programmes (Oxford Medical Publications) by Michael F. Drummond,‎ Mark J. Sculpher,‎ Karl Claxton,‎ Greg L. Stoddart,‎ George W. Torrance Show Notes: What is Health Economics [01:52] James’s personal story: career path to HEOR [06:09] Daily routine of HEOR professionals [13:26] NICE and other HTA [14:30] HTA in the United States [15:15] HTA vs. MAC [16:30] The future of HEOR [18:59] Hospital Readmissions Reduction Program (HRRP) [19:58] Economic value and what should a medical product start-up do? [24:17] How to find HEOR consultants [25:00] Qualities of HEOR people [28:06] Health economic model: how to make one? [28:57] Working with Medicare Administrative Contractor (MAC) [31:38] The future of HEOR (continued) [33:20] On Big Data [34:57] Leveraging HEOR data in countries such as US and Japan [36:52] How does HTA function in the US [38:26] Resources and guidance documents on HTAs [40:23] HTA review process in Japan [43:30] Trick to learning other therapeutic areas [47:55] What was most useful for you in this episode? Leave me a comment below and thanks for listening.

This is a solo episode where I share with you “13 Suggestions for Becoming a Great Clinical Project Manager.” If you are currently clinical project manager or desire to transition into the clinical project manager role, this episode is for you. This episode will also serve well for those interested in learning about what are the roles and responsibilities of a clinical project manager. In this episode, I’ll share with you the fundamentals, tactics and soft skills that turn a good project manager into a great project manager. At the most basic level, a project manager must be familiar with the clinical study protocol, clinical study procedure(s), and Good Clinical Practice (GCP) requirements. Next, a clinical project manager needs to be savvy with creating and managing study budgets, timelines and resources. Finally, the soft skills make a world of a difference between a good project manager and a great project manager. I’ll share with you 6 specific soft skills that will help you exponentially if you are really serious about the clinical project manager role. Thanks to my blog reader Christopher B. for recommending this topic. Do you have a topic idea for my next podcast episode? If so, leave me your suggestion is the comments section below. About This Podcast Episode: Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.” Selected Links from the Episode: Connect with me (Kunal) LinkedIn | Twitter The Ultimate Guide to Clinical Trial Costs FDA Good Clinical Practice Guidance Learn Microsoft Excel and other Microsoft Office Tools SkillShare Udemy YouTube Microsoft Office Products Microsoft Project to create timelines Microsoft Excel to create and manage study budgets and timelines Office Timeline, a Microsoft Powerpoint plugin that helps you create beautiful clinical trial timelines Create graphics and slides using Canva Books Mentioned: Sapiens: A Brief History of Humankind by Yuval Noah Harari The Inevitable: Understanding the 12 Technological Forces That Will Shape Our Future by Kevin Kelly Show Notes: Protocol, follow-up requirements and adverse event reporting [01:26] Understanding the clinical procedure [4:42] Good Clinical Practice [6:02] Managing a clinical study budget [7:20] Proficiency with Microsoft Excel [8:22] Developing and executing on study timelines [14:41] Managing study resources [22:05] Paying attention to compliance [24:02] Being self-aware [28:13] Being objective in your decision-making process [29:40] Being proactive and results driven [31:04] Ask questions and be curious [32:58] Explain your thought process [36:40] How to communicate effectively [38:05] QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

Conversation with Clinical Development Veteran Marshall Cool “There are a lot of things we can do, but we want to make sure we’re doing what we want to do” - Marshall Cool In this interview, I talk to one of my dear friends Marshall Cool, who also turns out to be a clinical research veteran. Marshall brings to us his over two decades of clinical development experience, including his time at Abbott Vascular, leading one of the most exciting post-approval medical device studies, XIENCE V USA. Marshall also has significant experience managing Investigator Sponsored Studies (ISS) and clinical research organizations, details of which he shares with us during this interview. In addition, Marshall is an avid reader and loves books. Please enjoy my conversation with Marshall Cool. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.” Selected Links from the Episode: Connect with Marshall Cool LinkedIn CSU Annual Biotechnology Symposium Bristol-Myers Squibb Abbott Seth Godin Blog Center for Disease Control National Institute of Health Office of Inspector General Medical Affairs Strategic Summit (West) Medical Affairs Strategic Summit (East) ACRP Investigator Initiated and Sponsored Research Interest Group Books Mentioned: The Road to Character by David Brooks Chronicles of Narnia by C.S. Lewis and Pauline Baynes Linchpin: Are You Indispensable by Seth Godin The Checklist Manifesto: How to Get Things Right by Atul Gawande Show Notes: Description of what a clinical researcher does [02:10] Early days in clinical research [04:23] Roles and responsibilities of a clinical research associate (CRA) [08:55] You don’t need an M.D. or Ph.D. to be in clinical research [10:55] Relocating for jobs [13:20] Transition from pharma to medical device clinical trials [15:55] What to do when you lose your job [19:46] Getting into the habit of reading and how it can help your clinical research job [26:31] Getting to First Patient In (FPI) for a post-approval medical device study [31:50] Onboarding a clinical research organization (CRO) [39:15] Investigator sponsored studies (non-company sponsored research) [41:30] Starting your career in Phase I-III research [45:45] Marshall’s #1 advice to listeners [56:30] My motivations for starting the Clinical Trial Podcast [1:01:33] QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.  

“Life is an adventure” - Gary Thompson In this interview, I had the pleasure to speak with one of the most optimistic individuals on the planet, Gary Thompson. Gary is the Vice President of Clinical Research at Abbott Vascular. In this interview, Gary shares a ton of valuable information on career choices, his #1 advice for all managers, and the relationship between money and happiness. In his free time, Gary loves to sail and is a proud owner of two sailboats. We discuss how sailing and clinical research are related in more ways than you can imagine. Enjoy my interview with Gary! Selected Links from the Episode Dr. Melvin P. Judkins Japan Ministry of Health Hobart “Hobie” Alter Show Notes: Advice on how to get into clinical research [1:20] Working in Japan [7:33] In-direct career paths [11:10] How to decide when considering a new clinical role [13:12] What it takes to work in a new geography [19:22] Most valuable lesson for all managers [23:26] Succeeding in the absence of a typical American childhood [25:56] Importance of work life balance [28:38] On sailing and how it applies to clinical research [32:46] Why you should take time off [41:44] Being present and meditation [43:30] Calling friends and family during the daily commute [47:20] Taking advantage of the right opportunities [57:30] QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

Download Episode “It’s important to make things clear and also look at it from the lens of public health not just from the lens of business.” - David Rutledge “Don’t let the place you begin dictate the place you end up” - David Rutledge My guest on today’s podcast is David Rutledge. David is a Regulatory Affairs Director at Abbott Vascular. David is an expert in Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) which form the foundation of medical product approvals and license renewals worldwide. In his previous role as a Clinical Research Director, David has led publications strategy for Abbott’s medical products including the blockbuster XIENCE V drug eluting stent. David has also served on the FDA advisory committee for four years prior his industry experience. David is my go-to person for advice on interpretation of Meddev regulations and the Medical Device Regulation (MDR). He is also a regulatory and quality expert presenting at many conferences and providing input on draft regulatory guidance documents. Enjoy my interview with David! Selected Links from the Episode: Connect with David Rutledge LinkedIn Six Sigma CFDA demonstrates the wisdom of Confucius. He said, “By three methods we may learn wisdom: First, by reflection, which is noblest; Second, by imitation, which is easiest; and third by experience, which is the hardest.” Food and Drug Administration Harvard Business Review Books Mentioned: Simple: Conquering the Crisis of Complexity by Alan Siegel and Irene Etzkorn Steve Jobs by Walter Isaacson Chess Not Checkers: Elevate Your Leadership Game by Mark Miller The Art of Asking: How I Learned to Stop Worrying and Let People Help by Amanda Palmer Kiss, Bow, Or Shake Hands: The Bestselling Guide to Doing Business in More Than 60 Countries by Terri Morrison and Wayne A. Conaway Show Notes: How to pierce through clinical study reports and making insightful comments [09:45] About Six Sigma certification [17:05] Three basic skills that will make you a better CRO or medical writer [21:59] Developing competency in quality systems [31:05] Paying for certifications and training [34:40] Guidance for productive one-on-one meetings with managers [37:00] Learning from the mistakes of others [40:18] Keeping current with latest developments in clinical research industry [42:41] Working in China and the CFDA [52:20] Taking ownership of your career [1:02:45] QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.