The FDA and the Clinical Trials Transformation Initiative (CTTI) will be collaborating to establish a new external work group related to patient engagement at the FDA. The FDA has long involved patients and considered patient perspectives in its work. This new initiative is part of the FDA’s continued commitment to fostering greater patient participation and input in regulatory medical product matters. Stakeholders suggested an external work group as a way for FDA to enhance patient engagement (View Report).

The FDA will leverage CTTI’s strengths in multi-stakeholder engagement to coordinate the new work group. CTTI, a public-private partnership, has a strong community of patient advocates and caregivers within its membership. The new work group will create a forum to exchange information, ideas, and experiences on matters of interest to patients and patient advocates related to patient engagement at the FDA. The work group will be similar to the European Medicines Agency’s Patients’ and Consumers’ Working Party, which marks its 10th anniversary in June 2016.

Additional details will be released as the work group develops.