As documented in a recent JAMA viewpoint article, the US FDA is making moves to integrate patient perspectives throughout the continuum of medical product development. While the FDA and other key stakeholders have declared a commitment to create a more effective model for engagement between research sponsors, investigators, and patient groups, no evidence-based guidelines for best practices have existed, until now.

On October 7, CTTI released recommendations that identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools. These recommendations are the result of CTTI’s Patient Groups & Clinical Trials Project.

How and when should patient groups be engaged in the research and development continuum? How do patient groups and sponsors of research best assess each other’s interests, expertise and assets to increase the chances of successful clinical trials and therapy development? We are proud to offer actionable solutions to these questions around patient engagement and encourage you to share them with colleagues involved in the clinical trials enterprise.

“The FDA is committed to integrating patient perspectives into its regulatory evaluations and decision making and also encourages medical product innovators and clinical researchers to collect information on patient perspectives to inform development programs.” (Source: JAMA)