How Can We Manage the Increasing Complexity of Clinical Trial Protocols? Interview with Ken Getz of Tufts Center for the Study of Drug Development

Atul MahableshwarkarDr. Atul Mahableshwarkar is the Senior Vice President of Drug Development at Emalex Biosciences. He is a trained psychiatrist who began his career in clinical practice and academia. Since joining the pharmaceutical industry, he has had the opportunity to learn from both successes and failures in his clinical trial work at companies of all sizes.Atul shares that early in his career, he was more interested in research than methodology. He credits his colleagues at the time with opening his eyes to the fact that incorrect operations can sink an otherwise viable product. The interest in methodology that that understanding sparked has shaped his career over the last 15-20 years.Episode HighlightsThe pivotal role of strong methodology in allowing good products to succeedAtul’s advice for others beginning to design clinical trialsWhat he sees as the greatest challenges clinical trials have in commonHow teams can help motivate clinical trial participationWhere standard concepts of patient-centricity may be lackingHow collaboration can help minimize mistakesThe Orphan Drug and Fast Track designations Emalex has earned from the FDA, and how other organizations can pursue Orphan Drug statusHow the pandemic nearly tripled Emalex’s enrollmentThe importance of supporting sites that may feel threatened by decentralized clinical trialsThe pandemic-enforced recruitment practices he plans to continueKey considerations in choosing a preferred ratings scale, and what his isRater training as a misnomer that needs revisingHow to assess and manage raters appropriatelyThe value of monitoring data and communicating insights to stakeholders in real timeLinkshttps://www.linkedin.com/in/atul-mahableshwarkar-07772338/https://emalexbiosciences.com/https://isctm.orghttps://cnssummit.org

Jennifer Brandl is the Associate Director of Clinical Operations at Kezar Life Sciences. She has 15 years of experience as a researcher and clinical operations specialist, and she is currently pursuing a Master’s degree in Data Science from the University of Wisconsin.Jennifer credits her prior experience at a smaller biotech company with giving her a critical foundation in clinical conduct and study execution. At Kezar, she leverages this expertise and her passion for research to support the company’s development of pioneering therapies and to change the lives of patients.Episode HighlightsThe elements of Jennifer’s expertise that have especially helped her drive success in the trials she managesThe benefits of functional service provider outsourcing modelsHow Kezar’s patient-centric nature had the company well prepared to navigate the COVID-19 pandemicThe greatest challenges Jennifer and Kezar experienced due to the pandemic, and some positive outcomesImportant considerations for organizations exploring home health optionsHow communication and relationship-building form the foundation of clinical trial workThe challenges and benefits she’s experienced conducting site initiation visits virtuallyHow best to prepare before updating or transforming site initiation processesWhat she believes is next for decentralized clinical trialsHow automation and tech adoption can help extract more insight from dataResources:Kezar Life SciencesJennifer Brandl on LinkedInConversations in Clinical Trial Readiness Interview Series

Ahmed HamoudaAhmed Hamouda is the Head of Clinical Operations in the Middle East and Africa at RAY. In more than 10 years in the clinical research field, Ahmed has worked on both the CRO side and the pharmaceutical side in Europe, the Middle East, the Far East, and Africa. Ahmed brings the full range of his experience to bear at RAY, which provides outsourcing and consulting services to support pharmaceutical and biotech companies through the clinical trial development process. With RAY, Ahmed leverages his expertise to bring hope and opportunity to patient populations who would not otherwise be reached.Episode Highlights Why Africa and Middle Eastern markets represent a major opportunity for sponsorsWhat regulations and unique requirements sponsors need to understand before moving into these marketsHow the site selection and preparation process is different in these markets as opposed to in the U.S.The importance of partnering with qualified regional experts The challenges involved in driving patient participation in these regionsHow one rare disease clinical trial was saved by a move from the U.S. to the Middle East, and how that move paid off in terms of recruitmentPotential logistical issues with global trials and how RAY manages themWhy continuous education is so important for sitesHow Ahmed and RAY estimate the timeframe for study startup in a new regionThe unexpected positive regional outcomes of the pandemic  Resources:Ray-CRO Ahmed Hamouda on LinkedInConversations in Clinical Trial Readiness Interview Series

Peju OshisanyaPeju Oshisanya is a Director and Clinical Program Leader at BenevolentAI. With more than 20 years in the drug research industry, Peju is an expert in pharmaceutical organization. Her career has run the gamut from early roles as a clinical trial associate to extensive experience running a wide range of global clinical research programs. In her role at BenevolentAI, she pairs her biomedical science background with further perspective from the tech side.Peju is a passionate proponent of diversity in data and inclusion in clinical trial research. She believes that problems of diversity and inclusion are fixable, and she has determined to become a champion of that change, working to raise awareness and dedicating her own career to upend the status quo.Episode HighlightsPeju’s “aha” moment that drove home the magnitude of inequity in biopharma, health, and clinical trialsWhy it’s crucial to really understand the communities that we want to include in researchHow decision-makers’ personal perspectives influence which diseases are prioritized and which treatments are fundedWhy representation needs to extend to the experts rather than stopping with the patient populationWhy it’s misleading and counter-productive to frame populations using the term “minority”How helping patients understand the importance of research in informing treatments can help motivate participationThe huge potential opportunity Africa represents for clinical trialsThe problem of perception when it comes to African institutions’ preparednessHow mining past data can create a self-perpetuating cycle that prevents capable sites from becoming experienced sitesWhat we can do to help ameliorate diverse patient populations’ trust in the healthcare industryHow anyone, regardless of their role within a company, can take steps to influence diversity in researchHow the pandemic has signaled hope for diversity and inclusion going forwardResources:Peju Oshisanya on LinkedInBenevolentAIConversations in Clinical Trial Readiness Interview Series

Ken Getz is the Director of the Tufts Center for the Study of Drug Development and a Research Professor at the Tufts University School of Medicine. Ken is an expert in drug development management and practices who has dedicated much of his career to raising awareness of clinical research enterprise.In addition to frequently speaking at industry events and publishing in peer-reviewed journals, Ken is the founder of several organizations, including the non-profit CISCRP and the publisher CenterWatch. His career is a true testament to his belief in the importance of transparency and keeping all clinical research stakeholders well-informed.Episode HighlightsThe takeaways, both expected and surprising, from 2020 protocol performance dataThe factors that are contributing to increased complexity in clinical trial protocolsWhy simplifying the design of a study is not the right goalThe inherent benefits in complexity, and how we can reap them through proper managementWhat drives regulatory agencies to seek to quell rising complexity in clinical trial protocolsWhy more data isn’t necessarily betterThe importance of investigating underlying causes of problems rather than defaulting to solving them with volumeWhat happened to feasibility committees and what should replace themWhy it’s critical to incorporate patient input into study designThe consistent positive impact of patient advisory boardsHow taking the time for thoughtful advanced planning can help preclude costly unplanned amendments later onResources:Tufts Center for the Study of Drug DevelopmentKen Getz on LinkedInCISCRPCenterWatchConversations in Clinical Trial Readiness Interview Series

Rebecca Setta is an Associate Director at OncoSec whose 13 years of experience in clinical trials have given her the benefit of several different perspectives. Rebecca began her career on the vendor side, and her continuous pursuit of development and higher-level understanding led her to transition to the CRO space in 2015. Her role at OncoSec represents the natural evolution of a career shaped around an inherent desire for growth through further immersion in clinical trials.In Rebecca’s years of experience at the project level, she consistently found building effective teams to be among the most rewarding elements of her work. She now brings that expertise to bear at the department level, where she can act as a mentor, shaping a team to build on her knowledge and experience. Episode HighlightsHow Rebecca helps her team avoid burnout in a grueling fieldThe common characteristics she saw across the sites that adapted best at the start of the pandemicThe crucial change in mindset that she’s encouraged in her CRAsThe COVID-inflicted adaptations she expects to persist post-pandemicWhy it’s important to partner with sitesThe unexpected upside to the pandemic adjustments her sites have madeWhat really impresses her about the industryHow remote work and limited face time can impact morale, and one way she compensates for thatHow the weighty context of oncology research can also translate to motivationWhy she is so excited about the future of the industryResourceshttps://oncosec.comhttps://www.linkedin.com/company/oncosec-medical-inc/https://twitter.com/oncosec

Topics covered and questions you’ll uncover during this episode:The three tenets of OncoBay’s approach to cutting-edge cancer researchHow to prepare staff for the complexities of a 21st-century oncology trialWhy we need to evolve from serial to real-time data assessment OncoBay’s “just-in-time” enrollment model (and a touching success story)Why investing up-front in site preparedness is critical to maximizing impact in researchHow the just-in-time model can help address diversity challenges in enrollmentWhy new technologies and methodologies often create discomfort, and what leaders can do about itHow you can make 1 + 1 equal 3 when you combine tools effectivelyWhy putting together the right team is both more challenging and more critical than putting together the technologyWhat Krystyna looks for when assessing potential team members Why she’s excited for the next generation of industry employeesResources mentioned within the episode:https://www.oncobay.comhttps://www.linkedin.com/company/oncobay-clinical/https://www.facebook.com/oncobayclinicalhttps://twitter.com/OncoBayConversations in Clinical Trial Readiness Interview SeriesArcheMedX

Topics covered and questions you’ll uncover during this episode:Why brick-and-mortar and virtual constitute a continuum, not a dichotomy. What teams need to do to be successful transitioning to virtual.Why remote monitoring still poses a challenge.Why tech isn’t always optimized for the site side.How remote improves patient engagement and retention.Why the clinical research coordinator role is changing, right down to the essential skillsets.What we need to do to make sure site coordinators are comfortable enough to be effective with the tech they need to adopt.Why we’re probably a long way from seeing virtual as a money-saver, and what will need to change to make it cost-effective.How lessons learned in the late 90’s can be an instructive cautionary tale today.Resources mentioned within episode:www.velocityclinical.comwww.archemedx.comwww.linkedin.com/in/klritchwww.linkedin.com/in/paul-evans-02118957

Topics covered and questions you’ll uncover during this episode:How excellence in site management has changed since the pandemic.Why the sites are still the lynchpin.Why anxiety around decentralized clinical trials is misplaced.How a marketing perspective can serve clinical operations and site management.What sets sites apart that will succeed and sites that will struggle in this new landscape.Why it’s important to assess a site’s tech-readiness and physical situation before handing down directions on how a study will be run.Simply providing a site with technology isn’t enough, so what else needs to be done?Why prevention and preparation beat correction and remediation.How to maximize collected data through follow-up and implementation.Resources mentioned within episode:MedableArcheMedXKelly Ritch on LinkedInMary Costello on LinkedInConversations in Clinical Trial Readiness Interview Series

Episode Highlights:The industry and operational challenges facing DCT adoption.How inconsistent nomenclature has contributed to widespread misunderstanding of DCT, and how misnomers have slowed adoption.The challenge of change management and how clarity and infrastructure can be an antidote.How DCT can help boost minority representation in clinical trial research, and why shifting those numbers requires time. How sponsors can get started with DCT and what they need to consider.Why organizational fit is critical and how to assess it.Why it’s so important to talk with the patients and understand the challenges they face.Why DCT and patient-centric approaches so often go hand-in-hand.How patient engagement is changing, and why clinical trials need to adapt to that.How sites have been forgotten as stakeholders and why they’re still central to clinical development.Resources:www.archemedx.comConversations in Clinical Trial Readiness serieswww.revelesclinical.comwww.linkedin.com/in/klritchwww.linkedin.com/in/r-kes-starling-rph-mba-9996214/www.clinicaltrialpodcast.comReveles’ Decentralized Clinical Trial Grader: https://form.typeform.com/to/RhOpipVQhttps://www.linkedin.com/company/reveles-clinical-services