The first ever meeting of the FDA’s new Patient Engagement Advisory Council (PEAC) will be this fall, as they host their first open forum focusing on the topic of clinical trials. This council came about due to legislation passed in 2012 that required the FDA to consider patient input when working on the development of new medical products- both drug therapies as well as medical devices. Patient advocacy groups have voiced the need for patient input in these processes for years leading up to the formation of this council. We remain hopeful that this is a step towards ensuring that medical product development and clinical trials place a high priority on patient-centered outcomes.
The meeting, which is open to the public, will be held on October 11-12, 2017 in Gaithersburg, MD. The dialogue will focus on challenges of clinical trial design, conduct, and reporting.
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 official meeting announcement includes further details on the meeting location, schedule, opportunities for patients to present, and disability accommodations.