The U.S. Food and Drug Administration (FDA), working with the Clinical Trials Transformation Initiative (CTTI), is asking for nominations of patient advocates interested in participating on the Patient Engagement Collaborative (PEC). The PEC will be an ongoing collaborative forum coordinated through Patient Affairs Staff, Office of Medical Products and Tobacco, Office of the Commissioner, and will be hosted by CTTI.
The PEC will offer patient communities and regulators an opportunity to discuss a wide range of topics designed, in part, to promote patient engagement in medical product development and regulatory discussions with the FDA.
The PEC is designed to provide diverse perspectives on topics including systematic patient engagement, transparency, and communication; providing considerations for implementing new strategies to enhance patient engagement at FDA; and proposing new models of collaboration in which patients and patient advocates are partners in “certain aspects” of the medical product development and FDA’s review process.
Nominations are due by January 29. Nominations received after that date will be retained for future consideration, FDA says. FDA asks, but does not mandate, that all nomination materials are compiled into a single PDF file and attached to the submissions e-mail.
For more information, contact Andrea Furia-Helms, Office of Medical Products and Tobacco, Office of the Commissioner, FDA, 10903 New Hampshire Ave., Bldg 1, Rm. 1316, Silver Spring, MD 20993, or PatientEngagementCollaborative@fda.hhs.gov. She can also be reached at 301-796-8455.
Author: Michael Causey
Learn More About CTTI
CTTI is a public-private partnership to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials.
Learn more about CTTI – and its initiatives – during ACRP 2018 this coming April! Senior executives from CTTI are presenting several sessions at the premier education and networking event for clinical research professionals, including:
- Meet the Changemakers: Driving Clinical Research Quality Through Collaborative Leadership
- Investigator Perspectives and Insights on the Use of Mobile Tech in Clinical Trials: Findings from CTTI’s Mobile Clinical Trials Project
- Defining Quality in Clinical Trial Conduct and Preparing Investigators for Success: Findings from CTTI’s Investigator Qualification Project