Clinical research and clinical trial management form the backbone of drug and device approvals worldwide. Learn from the leading industry experts to build and advance your clinical research career.
You'll hear from sponsors, clinical research organizations, and clinical trial sites around the globe. This show is for all current and aspiring clinical research professionals including clinical research associates (CRA), clinical operations managers, study managers, biostatisticians, medical doctors, safety monitors, clinical scientists and other healthcare professionals.
Solving Patient Recruitment Challenges with Maya Zlatanova
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
Society of Clinical Research Sites (SCRS)
Association of Clinical Rese
Patient Centricity in Clinical Trials with Craig Lipset
Managing and Communicating Clinical Trial Finances with Blake Peters
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
Virtual Clinical Trials with Mike Novotny
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
CTP 026: Conducting Clinical Research in Egypt with Ahmed Hamouda
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.
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
CTP 025: Role of Field Clinical Engineer (FCE) in Medical Devices with Ravi Shankar
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.
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