FDA sets inaugural meeting of first-ever Patient Engagement Advisory Committee

Kathryn O’Callaghan, Assistant Director for Strategic Programs, FDA’s Center for Devices and Radiological Health By: Kathryn O’Callaghan and Jeffrey Shuren, M.D., J.D. Imagine checking your blood sugar levels several times a day with a glucose meter to keep your diabetes under control. Or maybe you’ve had a hip joint replaced or a stent inserted in your coronary artery to treat a heart blockage. Maybe you participated in a clinical trial to help researchers or a manufacturer better understand a new device to treat a condition. It’s possible that you had some unexpected experiences with the device or clinical trial and you’d like to share what happened with your physician, the manufacturer, other patients or even FDA. Now, there’s a way. For the first time, an FDA advisory committee will focus on patient-related issues. On Oct. 11-12, 2017, FDA will hold the inaugural meeting of the new Patient Engagement Advisory Committee (PEAC). The topic will be the challenges of clinical trial design, conduct, and reporting identified by patients. FDA chose this subject because patients often have concerns about participating in clinical trials or drop out once they have enrolled in a trial. Inconsistent or minimal participation in clinical trials can make it difficult to reach reliable conclusions or to determine the level of benefit for patients. It also can take longer to bring technological advances to the patients who need them. We also are excited to announce that the ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog FDA Voice Source Type: news