WCG Talks Trials

Bernadette Siddiqi, associate director of research partnerships at The Michael J. Fox Foundation for Parkinson’s Research talks about how they give members of the public access to the Fox Trial Finder. This clinical trial search tool that allows anyone to search for Parkinson’s disease clinical trials. More than 300 are listed on the site.
It’s a bottleneck in clinical research. Patients are eager for a cure, but it can be difficult for them to connect to trials and for researchers to connect to volunteers.
Bernadette speaks of why it is critical to the foundation’s mission to provide an easy way to make this connection. Just as important, she says, is educating people about research. Fox Trial Finder provides both. Roughly 700 people visit the site each month.
The Michael J. Fox Foundation for Parkinson’s Research is dedicated to finding a cure for Parkinson’s disease through an aggressively funded research agenda.

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.

Join Desiree Underwood-Williams, director of project management organization at WCG and guest Steve Smith, CEO of SteveSmithPlans LLC and facilitator of the WCG Patient Forum, as they recap the latest Patient Forum Focus Session on breakthrough science and community engagement. Discussion highlights include:

• The impact of medical diagnoses on families with Sickle cell disease and melanoma.
• New research in cell and gene therapy that’s directly impacting Sickle cell disease and melanoma patients.
• New diversity laws shaping the future of drug development.
• Community engagement and how patients can get involved in their care.
• And more insights into the WCG Patient Forum, now in its fifth year.

Tune in to learn more about clinical research, community engagement, and the latest developments in patient care.