About this episode:
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, M.D., 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. That means sponsors will need to figure out how to account for variability and missing data in their statistical plan before locking their 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 that sponsors should 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 a 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. 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.