Clinical Trial Podcast | Conversations with Clinical Research Experts

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

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 whether they have direct responsibility for clinical trial finances. In this episode, I had the opportunity to speak with my friend Blake Peters who is exceptional at what he does with clinical trial finances. Blake is currently an Associate Director, Clinical Research at Abbot Labs. I'm excited to bring Blake on the show given his extensive experience managing multi-million dollar clinical trial budgets. We had an excellent conversation on a variety of topics such as careers, being resourceful, clinical trial finance, storytelling and presentation skills, and much more. I hope you enjoy this interview with Blake. Blake Peters on LinkedIn. How does one make a transition into clinical research? Core skills Bringing value to your team Helping clinical project managers forecast and estimate clinical trial costs Excel skills Data analytics Financial mindset Continued curiosity to learn and grow Transitioning from finance to clinical research Learning about the conduct of clinical trials Therapeutic knowledge On the job training A clinical research training conference Working with clinical project manager on finances Challenging clinical trial assumptions to optimize financing Historic data on benchmarking Hospitals are required to publish procedure costs Collaboration with finance on clinical trials and research Alignment on vocabulary, a common understanding of what each if try to talk about Maslow's Law of Hierarchy for Clinical Trial Costs Cost of the clinical trial - a list of expense type Cost driver - how to multiply the expense, scales with sites and/or patients or fixed expenses Timing of these expenses Factors that change the cost Total trial cost Clinical Research Organization (CRO) budget - ensuring you are not overspending when you decide to outsource Review project management fees Review monitoring costs Categorize costs into buckets or functional costs (safety, data management, operations, etc.) Becoming proficient in Microsoft Excel What do you find yourself doing manually and/or repeatedly? Be resourceful Spending 5-10 minutes can save you tens or hundreds of hours Research solutions (Youtube, Google) and implement Powerpoint skills in clinical research Understanding the message Meeting with the stakeholders Think about table vs. graphs vs. graphics Don't overdo animations First, get the content on the slide and then focus on the aesthetics of your slides Iterate, hit save and look at it again the next morning Types of PowerPoint slides Speak for itself with clean design Reference manual Different audience/ use cases Slides are an outward representation of the person who built them. They serve as an opportunity to show your creativity and can open doors for you Valuable skills for clinical research professionals Listening Public speaking/ storytelling Passion and inspiration Managing stress with diet, meditation, drinking a lot of water Resources mentioned: Abbott What Got You Here Won't Get You There: How Successful People Become Even More Successful by Marshall Goldsmith

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