Clinical Trial Podcast | Conversations with Clinical Research Experts

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 founding Medrio, Mike was president of Ninaza, an EDC software company, and had previously held roles as a research associate at the U.N. and a manager of the fraud database at VISA.  He holds a BA from Stanford University and an MBA from Columbia University. Mike founded Medrio in 2005 in San Francisco. I hope you enjoy my conversation with Mike. What is a decentralized or virtual clinical trial?  Benefits of a virtual clinical trial in patient recruitment The current model of clinical trials where recruitment is done through the doctor What does it mean to conduct a decentralized or virtual clinical trial? Case Study - CNS trials and how they can benefit from going virtual A limited number of patients (smaller patient pool)  Use of social media to find eligible patients The patient does not need to travel to the doctor's office, the caregiver goes to the patients home Medrio as a technology provider for virtual studies  eConsent Electronic data capture (EDC) Direct Data Capture (DDC) Randomization with EDC  Case Study - Cholera vaccine study in Yemen Collecting clinical data without an internet connection The downside of paper data collection DDC is a subset of eSource eSource can be EHR, DDC, ePRO, eCOA Future of EDC as we get more integrated with EHR Patient recruitment New efforts through AI Efforts through social media Genetic profiling Enabling participants to be anywhere in the world to participate in the trial Barriers to adoption Importance of monitoring in a virtual clinical trial to prevent fraud  The downside of a virtual clinical trial is the implementation Patients want their doctor to be involved New tools lead to new complications The trial does not match the decentralized model Common concerns from Sponsors Storing data on the cloud is risky Offline data management - what if the wifi goes down or there is no cellular signal Data loss - what if the tablet break Thinking in terms of relative risk Clinical trials fail 90% of the time Trial data is never looked at again Need to standardize audits to bring the cost down and improving the quality of the audit Medrio is focused on:  Speed Great tool for early phase diagnostic and device studies Customer service measured using net promoter scores eSource - Direct Data Capture (DDC) Optimism, focusing on the positive, not watching/ reading the news

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 selection meetings trying to determine whether you want to conduct trials in Egypt but have more questions than answers, this interview is for you.  You'll hear Ahmed breakdown the exact clinical trial conduct process in Egypt step-by-step. Ahmed has worked in a wide variety of professional capacities over different regions and markets in the Middle East, Gulf, Europe, and Asia. He is a pharmacist by education and received his MBA in 2013. Aside from being a clinical research professional, Ahmed likes to dive and explore new cultures. Show Notes: Ahmed Hamouda on LinkedIn Ahmed's background and experience working in the Middle East  Value of conducting trials in the Middle East A large population of over 300 million people 21 countries in the region Prevalence of diseases such as cardiovascular and hypertension Reasons why some Sponsors and CROs are not doing research in Egypt Lack of awareness of Egypt's capabilities  Long approval times for exporting blood samples  Importation process for medical products in Egypt Certificate of Analysis and quality documents Site Start-up Process Select sites Secure IRB approval (~1 month) Ministry of Health Approval i.e. MoH (~2 months) Observational trials can start right away Interventional trials require additional review (see below) Interventional trials (~2 months) Biological are submitted to The National Organization for Research and Control of Biologicals (NORCB) Non-biological are submitted to The National Organization for Drug Control and Research (NODCAR) Importing investigational medical product (IMP) Central Administration of Pharmaceutical Affairs (CAPA) Role of MoH vs. NORCB/ NORDCAR MoH will review study-specific documents such as protocol, eCRFs, CVS, patient-facing materials, insurance, patient diaries, signed contracts, etc. NORCD/ NODCAR will review information specific to the investigational product Process for adding more sites midway through the study Trial classification in Egypt - Phase I, II, III IRB rejections (decline) and how they are managed Product approval and commercialization  The concept around open-box vs. close box Pricing file is the limiting factor Naming list Pharmacovigilance (PV) files Contracts and Budgets Required at the time of IRB and/or MoH submission  Exceptions are handled via Sponsor/ CRO generated commitment letters Clinical Trial Research Units in Egypt  Allocation of budget and distribution between the site and the investigator Use of clinical trial contract templates  Contracts are in English and Arabic High-quality translations are achieved with the help of medically trained and certified translation company Site selection process  Lack of computerized system at the site can cause issues Career advancement for clinical research professionals in Egypt Social responsibility on part of CRO Other Resources: RAY CRO Pharma Med, a medical translation company ICH GCP Guidelines

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. In many ways, an FCE is a right hand to the physician.  In this interview, Ravi does a fantastic job of sharing with us the roles and responsibilities of the FCE, what to expect from an FCE, how to get hired as an FCE and the skills needed to become a great FCE, common mistakes and challenges faced by FCEs, and much more. Please join me in welcoming Ravi to the Clinical Trial Podcast. Show Notes: FCE provides in-person product expertise in a medical device trial setting (medical device boots on the ground for a clinical trial) Difference between Field Clinical Engineer (FCE) and Clinical Research Associate (CRA) Can/ should sales representatives serve as FCE on a clinical study? History of FCE role and how it all got started in Cardiac Rythm Management (CRM) and pacemaker space  Education qualifications such as biomedical engineering needed to become an FCE FCE training involves observing in the operating room. You may react a certain way when watching a surgical procedure You need to work and learn independently as an FCE Studies are not designed keeping in mind the execution. You need to incorporate scientific, marketing, statistical and research coordinator perspective when designing trials FCE should not sell. They need to focus on research. Visual tools in the operating room (OR), study guide summarizing the protocol, and inclusion/ exclusion cards are helpful  How do you find out about job opening for FCE role Sponsors need to think of any additional ask as a trade-off with enrollment. Qualify your asks as minor, moderate, or significant FCE training would include observing cases, speaking up during cases, developing soft skills, experience with active implantable devices, direct patient interaction, and working in an operating room environment Not all FCEs are engineers FCE is not practicing medicine. FCE is a coach to physicians and other medical professionals FCE needs to be balance action versus learning  Salary for FCE is similar to entry-level engineering roles  

Using Medical Records to Pre-Qualify for Clinical Trials with Komathi Stem The traditional model involves sponsors and CROs contracting with trial sites and hoping the sites will find and enroll eligible patients.  Through her work at monARC Bio, Komathi Stem is flipping the traditional model upside down.  In this interview, Komathi shares how patients can now share medical records for clinical research purposes.  Pharmaceutical and medical device companies can then leverage this data to easily identify potential clinical research patients. With the rapid growth of software technology and high pressure to keep medical costs down, there is a growing need and application of real-world data in clinical research.  For this reason, we are likely to see a rapid use of technology and the use of real-world data in clinical research and trial management.  In this interview, we'll cover the following topics: Why does monARC exists and what it does?  Data generated through routine clinical care and how to aggregate it Patient powered registries  Role of support groups, social media, clinician, and advocacy groups Mobile application to collect data between the clinical Understanding patient journey Geotargeting patients using Facebook Traditional versus "real-world" clinical trial Looking at the natural progression of the disease via a natural history study getting data on patients with no intervention Measuring treatment impact with a digital endpoint Impact of the intervention of Quality of Life (QoL) Challenges with real-world data  Access to the data Different formats and need for standardization Speed of decision making in big pharma Creating a sense of urgency using storytelling Importance of developing trusted relationships Future of electronic data capture (EDC) with the rise of real-world projects The current state of EDC and EHR integration Accelerating Research through Collaboration

In this interview, I had the honor of speaking with Richard Stubbs, who is the President of the New Zealand Association of Clinical Research.  Throughout my career, I've always been fascinated by clinical trials conducted in the Asia-Pacific region. Richard pulls the curtains for us today and shares with us how easy and valuable it is to conduct clinical trials in New Zealand.  Richard is a surgeon by training and also the managing director of P3 Research that is composed of three clinical trial sites in the region. We tackle a variety of topics including the regulatory framework, start-up process, and even the possibility of moving to beautiful New Zealand to learn and practice clinical trial management. I hope you enjoy this energetic interview with Richard Stubbs.  [Show Notes] A surgeon by training, president of P3 Research, president of New Zealand Association of Clinical Research (NZ-ACR), a national organization New Zealand has the first world health system Investigator and industry-sponsored research in New Zealand  Ethics committee approval process  Organization's mission is the education of clinical research site personnel (research coordinators, nurses, administrators) Conference every other year and then more frequent regional meetings Access to templates for contracts and indemnity documents, standardized for all sites across New Zealand, similar to MAGI template Schedule 6 in the contract allows sponsors to add additional verbiage in the contract Political activity encouraging the government to streamline the process for research (ex: New Zealand pavilion at BIO 2019) Provisional approved and what it means Medical device approval in New Zealand and how it's different from drug approval Regulations in New Zealand for Clinical Research Reasons why New Zealand is a great location to conduct clinical research, especially for early phase studies  Intellectual property protection No IND needed Fair budget Quick data Quality data Other regulatory bodies trust the data New Zealand is part of the Asia Pacific and Japan (APJ) region Site Selection in New Zealand  How to find sites What to consider Regulatory approval and site start-up processes in New Zealand Site start-up (gathering essential documents as governed by GCP) A centralized and electronic ethics approval process  Approval of the Ministry of health to allow the importation of the unregistered drug (SCOTT committee that replaces the IND)  Role of the ethics committee in participant reimbursement  Payment to patients generally diminishes with the increase in the phase of the study Importance of embedding clinical research in clinical care Overhead costs at public and private hospitals in New Zealand Only make surplus money out of clinical research is the volume Thinking of clinical research in terms of value to patients and their staff Moving to New Zealand to start a career in clinical research. There is a need for professionals such as doctors and nurses. Value systems in New Zeland such as men and women equality 

In this episode, I had the opportunity to speak with Antoinette Frankum, who currently serves as the Vice President/Executive Director of Clinical Research at CROMSOURCE, a global Clinical Research Organization (CRO). Antoinette has over 20 years' experience leading teams and managing complex clinical trials in the biopharma and medical device industry.  At CROMSOURCE, she is part of the executive team responsible for the US and international clinical operations.  Antoinette graduated from University of California, Los Angeles (UCLA), where she received her Bachelor's degree and executive management certificate. In this interview, Antoinette and I talk about what it takes to be a successful clinical project management professional. You will learn about effective ways to communicate with senior leadership, how to conduct a brainstorming session, the importance of a "Lessons Learned" document and much more. We wrap up on a very topic of growth versus fixed mindset.  My advance apologies for the poor sound quality in the first half the interview but the content is still audible (and valuable). Hope you enjoy this interview with the all amazing Antoinette (Torres) Frankum. Show Notes: Antoinette (Torres) Frankum on LinkedIn Project Manager versus Program Manager: what is the difference?  Technical skill sets needed to become an effective clinical project management professional Creating and managing study timelines including tools such as Microsoft Gantt Understanding your stakeholders in clinical research Investigators Patients Regulatory authority Understanding your stakeholders in clinical research Managing patient expectations Managing resources and budget How to assess clinical trial risks as a CRO? Feasibility  Identify what is going to impact timeline, budget, resources Quality issues The right way to conduct a brainstorming session with your team Why you should conduct lessons learned during the close-out phase? Abundance thinking (growth mindset) versus scarcity thinking (fixed mindset) Helping your executive team by problem-solving Effective communication strategies with senior leadership Sites and CROs are on the same team It is okay to make mistakes Communication and people skills will help you grow faster Asking for feedback and ways to improve as a clinical research professional Books Mentioned: Mindset: The New Psychology of Success by Carol S. Dweck The Gifts of Imperfection: Let Go of Who You Think You're Supposed to Be and Embrace Who You Are by Brené Brown Rising Strong: How the Ability to Reset Transforms the Way We Live, Love, Parent, and Lead by Brené Brown

In this episode, I had an epic conversation with an amazing human being who has been a force behind my clinical research knowledge and training. Jessie is a Project Director at Abbott. She has led several important clinical programs including the approval of Abbott's flagship medical device, the XIENCE V drug-eluting stent in the United States and Japan. Jessie is a wizard in clinical research processes and can systemize any broken process. She is also a world-class expert in the selection and management of clinical research organizations (CROs). In this episode, I had an opportunity to speak with Jessie about how to get into clinical research, outsourcing and supplier management, the evolution of the CRA role and much more. Please join me in welcome Jessie to the Clinical Trial Podcast. Show Notes: Getting into clinical research via technical roles such as data management and biometrics What makes a great statistician? Experience gained working for a big and small company Writing a statistical analysis plan Making CRO-Sponsor relationship work and how to succeed with outsourcing Getting unstuck - understanding how CROs and sponsors work Identifying clinical safety gaps and plugging in a CRO Protecting yourself as a sponsor when you outsource safety Working with CRO through iterations and why RACI may not work for you Outsourcing clinical events committee (CEC) and data safety committee (DMC) MEDRA coding: how it works, automation, generic versus specific coding Reducing CRO/ outsourcing budget and how to do it? Evolution of CRA role - drafting a protocol to writing reports Key Performance Indicators (KPIs) for a clinical research organization Turnover at a CRO and why it matters Financial KPI - money spent relative to the actions that were supposed to happen with that money Developing a process mindset - 5 major things that need to happen from beginning to end Evaluating employee performance relative to others Standing out by managing a chaotic situation, managing senior management discussions, ability to move the conversation along to get to a conclusion, working on "hot" projects that delivered results   Volunteer yourself to get involved Moving beyond conference calls and emails - pick up the phone and talk to someone Clinical research is about working in a field where your work really matters  

Karmen Trzupek, MS, CGC, is part of the leadership team at Informed DNA where she is responsible for ocular and rare disease genetics services. In this phenomenal interview, Karmen shares with us the world of genetic testing and the role it plays in clinical trials. Karmen is a certified genetic counselor since 2005. She earned her masters in Genetic Counseling from Northwestern University and a bachelor's in Microbiology from University of Illinois Prior to joining Informed DNA, Karmen was a genetic counselor and research assistant at Oregon Health & Sciences University. She has been a board member at the Hear See Hope Foundation and Usher Syndrome Coalition. Karmen is also a member of the National Society of Genetic Counselors, member and author of "NSGC Telegenetics Practice Guidelines" Working Group, member of the Association for Research in Vision and Ophthalmology, member and author of American Academy of Ophthalmology Clinical Working group to develop "Recommendations for the Clinical Assessment of Patients with Inherited Retinal Diseases" Her work has been published in GeneReviews; Current Opinion in Ophthalmology; Investigative Ophthalmology and Visual Science; Ophthalmic Genetics; Archives of Ophthalmology; and Ophthalmology Clinics of North America.Please join me in welcoming Karmen on the Clinical Trial Podcast. Topics discussed with Karmen: Evolution of genetic testing from one gene at a time to multiple genes at the same time Genetic testing in rare diseases such as inherited retinol diseases Cost of genetic testing Panel testing where multiple genes are tested at the same time How genetic tests are regulated Clinical trials in genetic testing and the benefits of genetic testing Role of a genetic counselor and how they work with patients, sponsors, patient foundations, and medical providers Recruitment challenges for sponsors for finding patients with rare diseases Use of telemedicine to expand access for patients Difference between genome and exome (whole) sequencing When is whole genome/ whole exome sequencing clinically relevant/necessary Our biggest challenge is trying to manage the volume of data Benign versus pathogenic variation in our genes What is Variant Interpretation crisis and Variant of uncertain significance (VUS)? Why insurance companies are willing to pay for genetic testing to determine the cause of the disease? Test the function of a particular genetic variance to: Identify patients Understand which patients qualify for gene therapy Very few drugs are approved for gene therapy for genetic diseases Antisense Oligonucleotide (ASO) Therapy How gene therapy is augmenting abnormal misfolded version of an amyloid RNA interference Therapy Precision medicine Difference between gene editing and gene therapy How does one become a genetic counselor? Why did we decide to start with gene therapy for retinal disease? Challenges with gene therapy Informed DNA team consist of genetic counselors primarily responsible for clinical, policy and consulting work Standards for panel testing