Clinical Trial Podcast | Conversations with Clinical Research Experts

Discover reasons for patient recruitment failure in clinical trials from an investigator perspective, such as funding deficiencies, logistical obstacles, and competing trials. Learn about challenges like burdening procedures, narrow eligibility criteria, and administrative constraints. Explore strategies to break into the clinical research field without prior experience and incentivizing site personnel for patient enrollment.

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 Vice President (DVP) of Regulatory Affairs at Abbott Vascular on the show. In this episode, Priya shares with us her experience and knowledge on regulatory affairs, specifically focused around medical device regulations in the United States. She does a great job of tailoring our conversation to make it applicable for clinical trial professionals. We cover topics such as working with the FDA, partnership between regulatory affairs and clinical research, career and professional development, and much more. The art and science of regulatory affairs is fascinating and there is no better person on the planet who can educate us on this topic. Please join me in welcoming Priya Jagasia on the Clinical Trial Podcast. Podcast Sponsor: This episode is brought to you by Florence Healthcare. To learn more, visit florencehc.com

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, research and technology. His company, Castor, provides useful technology for sponsors and sites to conduct decentralized clinical trials. What is great about Derk is that he is a physician by training and now runs a clinical trial software company. At a micro level, Derk understands the tools a doctor needs to provide optimal patient care in a clinical trial setting. At a macro level, Derk can see what it takes to conduct a clinical trial with multiple sites/ patients and how technology can solve such complex problems. This was a fun interview for many reasons. Derk talks about the future of Electronic Data Capture (EDC), his thoughts on what it means to run a decentralized clinical trial, most misunderstood aspects of DCTs, Castor's company culture, his favorite books, honey bees, and much more. I hope you enjoy this conversation with the all amazing Derk Arts on the Clinical Trial Podcast. This podcast is brought to you by Florence Healthcare. To learn more, visit https://florencehc.com/.

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 (PTSD). PTSD can occur after a person experiences a significant trauma, like a sexual assault, severe physical assault, significant threat to life arising from a hate crime, natural disaster, war, or accident. It affects people of all races, ages, and backgrounds. As you'll hear from Rebecca shortly, the clinical data from the recent clinical trial looks extremely promising. This interview will leave you with excellent insights on differences and challenges of conducting research with psychedelic drugs including site selection, patient recruitment, clinical trial design considerations and more. I am beyond excited to discuss this important topic of psychedelic research on the podcast. Please join me in welcoming Rebecca Matthews on the Clinical Trial Podcast. Enjoy! Podcast Sponsor This interview you brought you Florence Healthcare. Transform your Clinical Trials with the #1 Platform for Electronic Document Workflows and Remote Site Access. Learn how Florence Healthcare helps over 7,200 research sites, sponsors, and CROs across 27 countries take their day back from paper.

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 cardiovascular studies at Abbott Medical Devices. She has played a key scientific role in some of the largest drug eluting stent clinical trials from trial design to publications and presentations. It's because of Jenn's direct contributions as a scientist and scientific program director, many cardiology medical devices received FDA PMA approval or 510(K) clearance. Most recently, Jenn has been involved in Abbott's efforts in designing studies that include a diverse group of underserved clinical trial participants. As an African American woman, mother, and wife, she is an inspiration and role model for women interested in developing their career in clinical research. My interview with Jenn touches on a variety of topics including diversity and inclusion in clinical trials, developing a clinical trial strategy, working with key opinion leaders, skills you need to grow your career as a clinical scientist, and much more. I hope you enjoy my interview with Jennifer Jones-McMeans on the Clinical Trial Podcast.

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 research staff on the protocol and trial operations is useful and necessary. In this podcast interview, I speak with Joel Selzer, CEO & co-founder of ArcheMedx. Joel shares with us how the ArcheMedx team is using technology and behavioral science to improve clinical trial operations with a focus on study training. We also discuss the importance of adequately preparing sites and site personnel to conduct a clinical study, how sponsors and CROs can effectively deliver study content and much more. I hope you enjoy my conversation with Joel Selzer on Clinical Trial Readiness.

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, you must master soft skills. Soft skills, also known as "real skills", help you learn, adapt and grow. In this interview, I invited Ed Hogan, Executive Vice President (EVP) at Invicro, to talk about soft skills in clinical research. Ed and I first met in 2005. He was the Director for Medical Imaging at PAREXEL/ Perceptive Informatics, my first job out of college. Ed is now responsible for overseeing the clinical services team which includes project management, imaging services, data management and reader management for early and late phase clinical trials. Ed has close to three decades of experience in clinical research, managing, and executing Phase I through Phase IV imaging trials in both the Pharmaceutical and CRO space. He is THE expert when it comes to medical imaging operations. Ed has progressive business experience in building and managing global cross-functional teams supporting clinical trials focusing teams on delivery, accountability, and customer satisfaction while driving quality and process improvements. For these reasons, I invited Ed to talk to us about soft skills including negotiating contracts, how to develop a successful manager-employee relationship, what Ed looks for when he is wanting to promote someone on his team, leading effective meetings and much more. I hope you enjoy my conversation with Ed to the Clinical Trial Podcast [3:50] Soft skills and project management [4:54] Negotiating contracts with Sponsor including cost, study design, and operations [7:25] Offer Sponsors what they need and not nice-to-have elements [8:24] Clinical project managers are involved in finances [10:22] Ideally Sponsor should ideally have a direct communication with imaging CRO [11:59] Example of risk mitigation in clinical trials [13:39] Developing soft skills through PMP certification and courses and on the job training [14:45] Managing and working with project team members [17:21] Developing a strong team with diverse and complementary skills [19:01] Putting in time and practice to develop your skills [21:01] Soft skills are not easy to do [22:28] Key ingredients that make a successful manager-employee relationship [23:52] Giving direct and timely feedback [25:37] Feedback "sandwich" [26:32] Managers can plan and prepare before giving feedback. (a) State the outcome, (b) state the issue, (c) listen, (d) reinforce your intent to help, (e) repeat the end goal and expected outcome, (f) followup with an email [28:51] Practical advice on managing up [31:54] Giving and getting feedback from your colleagues [34:06] Developing writing skills [36:01] Understand pain points to create winning proposals [37:23] Finance skills such as dealing with budgets, ability to write and communicate effectively, multitasking, time management, learning styles are some of the skills Ed focuses on when promoting or hiring someone new [40:41] Getting your foot in the door with entry level clinical research roles [45:54] Dealing with emotional employees when giving feedback Resources Mentioned: Never Split the Difference with Chris Voss Project Management Professional (PMP) curriculum Radical Candor by Kim Scott StrengthsFinder 2.0 by Gallup (Author) The Five Dysfunctions of a Team: A Leadership Fable by Patrick Lencioni Myers Briggs Personality Test Official Microsoft Excel Video Training The 7 Habits of Highly Effective People by Stephen R. Covey Harvard Business Review for managers Atomic Habits: An Easy & Proven Way to Build Good Habits & Break Bad Ones by James Clear James Clear's newsletter

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 and PSPs in the MENA region and much more. This interview was recorded shortly after the explosion in Beirut in August 2020. I'd like to thank Maha for taking the time to chat even though her city was experiencing such pain. Maha has a bachelor's degree from the Arab University of Beirut. She has worked as Clinical Research Coordinator, Clinical Research Associate, Regulatory Affairs Manager, Clinical Project Manager and is currently the Clinical Operations Manager at Phoenix Clinical Research . Please join me in welcoming Maha on the Clinical Trial Podcast. Maha Dakhloul on LinkedIn

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 and what skills are needed to succeed in today's marketplace. Chris has over 20 years' experience leading teams and managing clinical trials in the medical device, biotech, and pharma industry. At IntersectENT, he serves as Vice President, Clinical and is responsible for developing and managing clinical programs. Chris graduated from the University of Louisiana, where he received his Bachelor's degree in Biology and an M.S. degree from George Washington University. During his spare time, Chris enjoys vacationing in our national parks with his family, trail running, camping, and pretty much every other outdoor activity under the sun. Please join me in welcoming Chris Lewis on the Clinical Trial Podcast. Chris Lewis on LinkedIn Trainual software for onboarding and SOP training How to Win Friends and Influence People by Dale Carnegie Good to Great: Why Some Companies Make the Leap and Others Don't by Jim Collins Show notes: 1:52 Chris unconventional path to clinical research career 2:38 Journey from research coordinator to vice president 3:18 Impact of rise in technology, remote monitoring and risk based monitoring on the CRA's role 5:49 Who is responsible for proctoring clinical trial cases? CRA or Field Clinical Engineer (FCE) 6:49 Importance of relationship management, technical expertise, problem solving skills and staying calm in the operating room 8:05 Building interpersonal skills through partnership and collaboration 9:34 Consolidation of electronic systems and access to sites 12:25 Process of hiring, interviewing and finding right talent 14:31 Leveraging social media (LinkedIn) and internal human resources systems for hiring 16:12 Getting to know someone through their hobbies, mannerisms, eager to learn, work hard, and ability to getting along with the rest of the team 18:03 The importance and process for having difficult conversations 22:53 Getting the new job posted Creating clear job description Making a request for requisition Getting it approved through HR and executive 23:29 Making an offer Confirm with HR is the requisition is still valid Obtain executive approval stage Clean communication between the candidate and hiring manager throughout the process 25:58 Onboarding new employees needs to be planned Create an onboarding plan Clearly articulate and set expectations Training Plan Assign a mentor/ buddy (not their manager) Weekly meetings Access to systems 28:34 Providing ongoing leadership and management 32:33 Core skills i.e. soft skills needed for a clinical research professionals How to get along with people and see their viewpoints How to manage a challenging situation 36:30 You don't need two years of experience to get a job in clinical research 38:03 Getting into clinical research career with no experience Getting a masters degree in clinical research Making contacts and exploring LinkedIn 39:19 How does living on the farm impact Chris's life at work ? 41:00 Take control of your career, have patience, get your manager to understand your career aspirations Resources Mentioned Abbott Trianual - software solution for onboarding and SOPs [Book] The 7 Habits of Highly Effective People by Stephen Covey [Book] Good to Great by Jim Collins The Clinical Research Administration Program at George Washington University

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 to connect with each other She believes in the power of stories, not just facts, something unheard of (but much needed) in clinical research. FindMeCure is dedicated to simplifying the patients' journey while volunteering for a clinical trial while helping the industry plan their trials with the full picture of country capacity, sites' experience and patients needs and journey. Maya is a healthtech entrepreneur, clinical research expert, and pharma industry speaker with over 15 years of global experience in clinical research regulations, patient recruitment, and engagement, clinical trial feasibility, and operations. Maya's strongest skill is empathy. Her principles in life are to be trustworthy, care for other people and give first. She also cherishes her never-ending curiosity about how life and the universe work, how to improve ourselves and our environment. Please join me in welcoming Maya Zlatanova on the Clinical Trial Podcast. [2:25] About Maya's company FindMeCure, Maya's experience working on clinical research software for the British government and first online GCP training [4:14] Maya's sister was diagnosed with an eating disorder and struggled to find treatment. This let to Maya looking at clinical trials from a patient perspective [6:06] Creating a global platform for patients to find out about alternative treatments in clinical trial setting [8:29] Connecting patients in one country with clinical trials in another country [9:55] Challenges for patients include: Human factors such as need to be close to family Traveling long distances to participate in clinical trials Being treated by different doctor (trial investigator) than their primary physician [13:01] Patient recruitment process can benefit from change. Currently we first select sites and then bring patients into these sites [14:26] We need to break things to innovate [15:25] In an ideal world, we would have a centralized electronic health record, we know where patients are, patients are monitored with telehealth solutions, central site that is leading other sites [16:55] Everyone wants to go to the experienced sites [19:43] Hybrid clinical trials [20:28] Need to support sites and investigators by questioning what sites should and shouldn't do [24:05] convincing decision makers to select sites in other geographies using financial metrics [28:03] Language is not an obstacle at most sites. Ethical considerations can pose an issue. CRO with local office Site Management Organization (SMO) Own CRA networks [32:00] Adoption of technology in clinical research such as sites being open to new remote solutions [33:35] Whatever works for clinical research will work for the healthcare sector [34:03] ACRES helping sites getting accredited and certified if they follow certain standards for clinical trials [36:32] GCP is the only standard in clinical research. For example, it is not sufficient for patient centric trials [38:02] Need to align on initiatives such as patient engagement guidelines in EU and USA [39:45] Empathy is a feeling for people and imagining yourself in their shoes. Being open to the fact that you could be wrong. Listening to people, hearing you are wrong, and converting to the right thing [42:42] Maya's secret weapon is speaking with different people with different backgrounds to learn and grow Resources mentioned: Society of Clinical Research Sites (SCRS) Association of Clinical Research Professionals (ACRP) Food and Drug Administration (FDA) Alliance for Clinical Research Excellence and Safety (ACRES) TransCelerate - Pharmaceutical Research and Development Pharmaceuticals and Medical Devices Agency (PMDA) EUPATI: Patient Engagement Through Education - EUPATI