Practices of patient engagement in drug development: a systematic scoping review

Abstract

Plain English summary This article summarizes what is publicly found in scientific papers about patient engagement in drug development initiatives between 2011 and 2021. It also introduces a new Framework to use to look at these patient engagement efforts. The Framework breaks these efforts down based on the depth of patient engagement in the drug development process and different degrees of influence or power patients have or intensity of engagement. In terms of depth of patient engagement in the process of drug development, most patient engagement initiatives described efforts involved in designing studies where goals were already set. Next were patient engagement efforts related to finetuning details where patients could make minor contributions. The fewest efforts were found related to setting up a research and development program where patients potentially could make significant impact. In terms of intensity of patient engagement, most initiatives aligned with consultation and involvement intensities, and few examples aligned with the highest intensity of patient engagement that was considered partnership. While patient engagement in drug development is becoming more common, the approaches to doing so vary widely. We have developed a new Framework to help characterize these efforts related to patient influence in the process as well as depth of their engagement.

Keywords

• Patient engagement
• Patient participation
• Drug development
• Systematic scoping review