Protecting Sponsors Against Bias and Variability

Clinical trials succeed or fail based on the ability of the primary endpoint to differentiate
study drug from control conditions. In the case of placebo-controlled studies, the
levels of random error, sources of noise, variability introduced by patient or investigator
factors, and placebo response rates can have a profound influence on the outcome. Design and execution teams can take several steps to reduce these risks, improve signal-to-noise ratios, and mitigate the impact of placebo response.

Applied Clinical Trials recently spoke with Mark Opler, PhD, MPH, chief research officer of WCG, MedAvante-ProPhase, to learn how these approaches need to be incorporated into standard practice to reverse prevailing trends going forward for certain therapeutic areas and conditions.

About the Author

Dr. Mark Opler serves as Chief Research Officer, directing scientific research and development at MedAvante-ProPhase. Dr. Opler was the founder of ProPhase and served as its CEO and Chief Scientific Officer among other positions. He holds the titles of Adjunct Assistant Professor of Psychiatry at New York University and Assistant Professor of Clinical Neuroscience at Columbia University’s College of Physicians and Surgeons. His academic research focuses on the etiology, phenomenology, and treatment of serious and persistent mental disorders. He is also leading the development of the new upcoming edition of the PANSS Manual©.

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