Technical Papers

Interventions to Reduce Placebo Responses in Clinical Trials

Placebo responses can significantly reduce assay sensitivity in clinical trials, causing randomized controlled trials (RCTs) of drugs that should be efficacious to fail. Patients’ expectations of benefit are considered one of the primary reasons placebo responses occur, and this phenomenon is especially important in RCTs which rely on patient-reported outcome measures as primary endpoints.

Interventions aimed at neutralizing patient expectations may help reduce placebo responses and increase assay sensitivity in RCTs, however few studies of such interventions exist. Analgesic Solutions has been a pioneer in developing and implementing effective interventions to reduce placebo responses based on years of research, all in an effort to help pharmaceutical and medical device sponsors conduct successful trials. As part of this ongoing research and development effort, we conducted a systematic, qualitative review of the literature to identify RCTs that evaluated the effectiveness of non-pharmacologic interventions on patient-reported outcomes.

The purpose of this report is to: 1) summarize the literature on the effectiveness of interventions designed to decrease placebo response rates in clinical trials; and, 2) provide recommendations for reducing placebo response rates in clinical trials. This report provides an evidence base that interventions or tools to neutralize patient expectations and reduce placebo responses in RCTs could potentially help bring new, efficacious drugs to market more efficiently by reducing the number of failed RCTs.

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