Advancing Meaningful Patient Engagement in Research, Development, and Review of Drugs

Meaningful patient engagement is a buzz phrase across the research-to-care continuum, but what it means from the patient perspective has been lacking in the dialogue.  

The National Health Council and Genetic Alliance convened a multi-stakeholder group of key health care thought leaders to help develop action steps for the integration of the patient perspective into drug research, development, and approval. The Dialogue event was attended by representatives from patient organizations, the federal government, academia, and industry.

The discussion at the Dialogue focused on arriving at a common understanding of what it entails to meaningfully engage patients, identifying key gaps in current patient engagement methods, determining the barriers to advancement, and providing next steps.

All stakeholders – the patient community, researchers, regulatory agencies, and industry – are identified as having important roles at different stages in moving patient engagement forward. For example, the white paper addresses

  • The need to create regulatory guardrails and enhance FDA division alignment on the use of tools for evaluating patient information;
  • The importance of promoting a culture shift to generate buy-in for patient engagement, creating accountability for collecting and integrating patient perspectives, and educating researchers; and
  • The tactics for facilitating opening communication, including creating a feedback system to inform patients about how their contributions impact decisions and making patient engagement successes and best practices both comprehensible and publicly available.

The resulting report discusses key themes from the Dialogue, which are intended to represent an initial conversation among stakeholders and a vision for advancing patient engagement. 

A follow-up meeting of the advisory group was held in December 2015 to deliberate on the general areas that need to be covered by a guidance document, and additional discussions are planned in 2016.

To read the full report, click on Advancing Meaningful Patient Engagement in Research, Development, and Review of Drugs.

Click the following links to access a recording of the webinar and the slides from the presentation


The National Health Council and Genetic Alliance greatly appreciate the educational grants from the following supporters that made this project possible: Biotechnology Industry Organization, Merck & Co., Novartis, Pfizer Inc., Pharmaceutical Research and Manufacturers of America, and Sanofi U.S.