Masking of Trial Investigators
The substantial investment of both time and money to mount a clinical trial would not be made without an underlying belief that the new treatment is likely beneficial. While a lack of definitive evidence can underpin the equipoise of investigators that is necessary to mount a new trial, the success in previous early phase trials (or even animal models) provides a natural foundation for an expected benefit in subsequent phase trials. Both investigators and patients can share this belief, and these expectations of treatment efficacy for new therapies introduce the potential for bias in clinical trials. The benefits, completeness, and reporting of masking in clinical trials are described, as they are approaches for implementing and maintaining the mask.
KeywordsMasking Blinding Assessment of outcomes
- Ndounga Diakou LA, Trinquart L, Hrobjartsson A et al (2016) Comparison of central adjudication of outcomes and onsite outcome assessment on treatment effect estimates. Cochrane Database Syst Rev 3:MR000043Google Scholar