Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 12 October 2017 | By Michael Mezher
The US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time on Wednesday and Thursday to give the agency input from patients on clinical trials for medical devices.
The meeting focused on a number of key issues related to clinical trials, with the goal of increasing patient input on trial design; patient recruitment, enrollment and retention; and communicating results back to patients.
FDA announced the creation of the PEAC in September 2015 as part of a broader effort under the 2012 Food and Drug Administration Safety and Innovation Act to bring patient perspectives to regulatory discussions.
The agency also agreed to further advance the use of patient preference information (PPI) and patient reported outcomes (PROs) in its commitments under the recently reauthorized Medical Device User Fee Amendments (MDUFA IV).
At the meeting, Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren said the agency will be better equipped going forward in its patient engagement efforts as a result of MDUFA IV.
"We're now—for the first time—getting resources to build out a patient engagement group at CDRH. Prior to that, believe it or not, there were never dollars that had been allocated to us specifically for this kind of work," Shuren said.
FDA recently indicated that it is interested in creating a new Office of Patient Affairs to better support and coordinate patient engagement activities across the agency.
With these efforts, and the development of guidance documents on PROs and PPI, Shuren said the agency has witnessed a major increase in the number of submissions that include patient-focused data.
"Over a five year period we saw an over 500% increase in the number of pivotal clinical trials for [premarket approval applications] PMAs that used patient reported outcomes, and now over 50% of our PMAs include patient reported outcome data," Shuren said.
As an example, Shuren pointed to FDA's recent decision to expand the use of the NxStage's System One hemodialysis device to allow for home use without a caregiver being present based on data from a patient preference survey.
Unlike FDA's other advisory committees, which are made up mostly of doctors and other experts usually with a single patient representative, the PEAC's members are primarily patients and patient advocates.
According to Shuren, the PEAC provides FDA and patients with a unique opportunity to engage on a deeper level than through other activities, such as the limited availability of public speaker slots at other public meetings and through comments to public dockets in the Federal Register.
"We have tried to include patients in our decision-making, but quite frankly the opportunities for patients to engage are very, very limited," Shuren said.
At other public meetings, he added, "people get two or three minutes to say something … We open up a public docket and you can provide comments, but how many people actually read the Federal Register?"
According to Owen Faris, clinical trials director at CDRH, FDA's goal is to find ways to make clinical trials and their outcomes more relevant to patients and reduce some of the burdens and barriers patients encounter when participating in clinical trials.
"We want the trial to be gathering information that's relevant to the patients that are going to be impacted by the use of the device … If patients have to come back too frequently, or have to drive too far, or spend too much time in the hospital, or do something that's really burdensome, we may get a lot of missing data," he said.
Tags: Patient Engagement, PEAC, Patient Engagement Advisory Committee, Patient Reported Outcomes, Patient Preference Information
Regulatory Focus newsletters
All the biggest regulatory news and happenings.