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.