from tHEORetically Speaking: The HealthEconomics.Com Blog at http://bit.ly/2tOU8xo on July 30, 2017 at 07:18PM
The Food and Drug Administration has scheduled the first meeting of the new Patient Engagement Advisory Committee (PEAC) for Oct. 11-12.
According to the FDA, the meeting will focus on clinical trial design, conduct and reporting identified by patients.
The FDA looks to address some of the challenges for clinical trial results which arise when patients decline to participate or drop out post-enrollment. Stunted participation in trials, per the FDA, “can make it difficult to reach reliable conclusions or to determine the level of benefit for patients.”
“(The PEAC) will be asked to advise on complex issues related to medical devices and their impact on patients,” the FDA says. “The goal of PEAC is to better understand and integrate patient perspectives into our oversight, to improve communications with patients about benefits, risks, and clinical outcomes related to medical devices, and to identify new approaches, unforeseen risks or barriers, and unintended consequences from the use of medical devices.”