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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.