About this episode:
In major depressive disorder, researchers have used remote assessments for decades. As a result, many of these studies have had an easier time adapting to the new clinical trial landscape. But that doesn’t mean they are pandemic-proof.
So what are the critical success factors for clinical depression programs—especially now?
In his conversation with WCG President of Patient Advocacy Steve Smith, Mark Opler, PhD, MPH, Chief Research Officer at WCG MedAvante-ProPhase offers his insights on the future of clinical depression trials. This is the third episode in our podcast series, “Transforming CNS Trials During COVID-19—and Beyond.”
We’re headed in the right direction by enabling more patient-friendly evaluation, and — especially in light of the pandemic — we must continue to refine these systems with the input of patients, caregivers, and of course, the investigators who ultimately use these evaluations.
Among his recommendations: Ensure clinicians have the right assessment tools and that they are using them correctly so that the subjective evaluation of depression is being done in a reliable and compliant way. In other words, sponsors should not only leverage secure, remote assessments and electronic diaries, but they should also take care to monitor the health of the data captured throughout the course of the study. WCG’s Study Insight Analytics Platform provides such recourse by allowing sponsors to identify and mitigate data-quality risks before the results of the trial are threatened. In this way, clinicians and patients can keep research going—without compromising data validity and integrity.
Mark Opler, PhD, MPH, is Chief Research Officer at WCG MedAvante-ProPhase. Dr. Opler was the founder of ProPhase and served as its CEO and Chief Scientific Officer, among other roles. He serves as adjunct assistant professor of psychiatry at New York University and assistant professor of clinical neuroscience at Columbia University’s College of Physicians and Surgeons. He is also leading the development of the forthcoming edition of the PANSS Manual.