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 nine core voting members of our patient advisory committee, including the chair and the consumer representative, all have direct experience as a patient or as a care-partner for a patient.
They are experts in the field of patient engagement, and their experience extends beyond their personal disease or condition to the broader patient perspective, which is a critical piece of FDA’s work. While patient representatives currently participate in many FDA advisory committee meetings, we’ve never had a committee that was wholly focused on patients.
The PEAC is a forum for the voice of patients. It will be asked to advise on complex issues related to medical devices and their impact on patients. 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.
Federal legislation enacted in 2012 instructed FDA to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussion. This gave us a welcome opportunity to establish the PEAC.
Our intent is to engage with and better understand the needs, views, and concerns of patients and other users of medical devices. After all, they are, along with their caregivers, the experts in terms of what they’re living with and what they have to deal with day-to-day.
We will also need better tools to accurately capture and characterize patient views on acceptable balances of benefits and risks. And, as the nascent science of patient preferences continues to evolve, we must adapt our policies, too.
Patients are at the heart of what we do. It makes sense to establish an advisory committee built just for them.
The nine core members of the PEAC are:
Paul Conway (Chair) – President of the American Association of Kidney Patients.
Katherine Seelman, Ph.D. – (Consumer Representative) – Retired from the University of Pittsburgh as Professor Emerita in 2016.
Cynthia Chauhan, M.S.W. – Served as a Patient Advocate for over 17 years. Served as an FDA patient representative for the National Mammography Quality Assurance Advisory Committee.
Amye Leong, M.B.A. – President and CEO of Health Motivations. Extensive patient advocacy history, communications specialist, health policy advisor, author.
Monica Willis-Parker, M.D. – Director, Minority Engagement Core, Emory Alzheimer’s Disease Research Center.
Frederick Downs, Jr., M.B.A. – Decorated Vietnam veteran, who retired from the Veterans Administration as the Senior Executive Service Chief Procurement and Logistics Officer.
Bennet Dunlap, M.S. – Health communicator and advocate for people with diabetes, with experience in social media and marketing programs.
Deborah Cornwall, M.B.A. – Patient advocacy expert. She is a longtime leadership volunteer for the American Cancer Society and the Cancer Action Network.
Suzanne Schrandt, J.D. – Director of Patient Engagement at the Arthritis Foundation.
Kathryn O’Callaghan is Assistant Director for Strategic Programs, FDA’s Center for Devices and Radiological Health
Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com.com or its employees.
