WCG Talks Trials

Movement disorder trials have always been demanding. Now, sponsors face an additional challenge: How do you ensure data integrity in the era of remote clinical trials? In this podcast, Bob Dagher, MD, WCG MedAvante-ProPhase’s Chief Medical Officer, addresses this in conversation with Steve Smith, WCG President of Patient Advocacy. This is the fourth episode in our series, “Transforming CNS Trials During COVID-19—and Beyond.”
Sponsors planning to restart movement disorder programs need to be clear-eyed and realistic, Dagher counsels. “When it comes to remote assessments, we have to be vigilant and aware of what we can do and also about what we really cannot do.” Some assessments simply cannot be performed remotely. This means sponsors will need to figure out how to account for variability and missing data in their statistical plan before locking the database.
FDA guidance on the conduct of trials during COVID-19 helps provide a roadmap. For example, in the case of anticipated missing data the guidance clearly states to capture specific information in the case report form that explains the relationship to COVID-19.
But it also requires in-depth scientific and clinically-informed knowledge so that the quality of the data captured isn’t sacrificed as direct result. Accordingly, WCG has been working with clients to tailor remote assessments for sponsors’ trials, yielding assessments that are as close as possible to the in-person versions (minus those particular items that cannot be done remotely).
Dagher’s message? “Ensuring data integrity at every step of the process should be the primary guide for any decision-making process when deciding to restart your study.”
Prior to joining WCG MA-PP, Dr. Dagher, was the Chief Medical Officer of Cadent Therapeutics in Cambridge, Mass. Before that, he served in many leadership roles at small and large biopharmaceutical and clinical research organizations, including GlaxoSmithKline, Genzyme, Sanofi and Covance, among others. Dr. Dagher has fostered the development of multiple products in different indications and development platforms and advanced several small molecules and biologics across all stages of clinical development. His background includes therapeutic experience in psychiatry, neurology and rare diseases.

In this episode, former Assistant FDA Commissioner Jonca Bull, MD, discusses racial disparities in healthcare, how COVID-19 has made them impossible to ignore, and how this highlights the need for diversity in clinical trials.

Low-income minority communities are being hit disproportionately hard by COVID-19. Dr. Bull isn’t surprised: The current crisis has simply magnified existing disparities. A multitude of factors are at play, including lack of access to healthcare and healthful food. As a result of these and other issues, certain underlying health conditions are more prevalent in low-income minority communities.

Clinical trials must include these populations so we can truly understand COVID-19 and how to treat it in real-world conditions.

In fact, the FDA has long had guidance on how to make trials more diverse:

• Collection of Race and Ethnicity Data in Clinical Trials—Guidance for Industry and Food and Drug Administration Staff
• Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry

She emphasizes that African Americans are willing--sometimes more willing than others--to participate in clinical trials. But they must be invited, and trials must be designed with consideration of the obstacles they face because of where they live and how they work.

Dr. Bull serves as a consultant focused on drug development and regulatory considerations; she helps guide the strategic development and implementation of clinical trial protocols. She has served in various roles, including as assistant commissioner at FDA with a focus on diverse populations and clinical trials.

In this episode, WCG’s President of Patient Advocacy, Steve Smith, sits down for an interview with Dr. David Fajgenbaum, Assistant Professor of Medicine at the University of Pennsylvania and Author of Chasing My Cure: A Doctor’s Race to Turn Hope Into Action. In this podcast, you’ll hear Steve and Dr. Fajgenbaum discuss what it’s like to be a patient of a rare disease – in this case Castleman’s disease – and Dr. Fajgenbaum’s fight to find a cure for his own disease. This is a story of incredible courage and uniquely acquired wisdom. It is a story of triumph over adversity. And it’s a story of life changing, groundbreaking hope.

In this episode, Mark Dant, Founder of the Ryan Foundation speaks with Steve Smith, WCG’s President of Patient Advocacy. Their conversation highlights the importance of Patient Advocacy Groups – and the resources they bring to individuals diagnosed with a disease – as well as the great promise clinical trials bring to patients. Mark shares a personal story of his son, Ryan, who was diagnosed with MPS I, and how Patient Advocacy Groups and clinical trials have positively impacted their lives.