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Patient Engagement in Device Trials: FDA Meeting Discusses Challenges and Opportunities

Posted 16 October 2017 | By Michael Mezher 

Patient Engagement in Device Trials: FDA Meeting Discusses Challenges and Opportunities

Last week, the US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time to look at ways to increase patient engagement in clinical trials for medical devices.

Owen Faris, clinical trials director at the Center for Devices and Radiological Health (CDRH), said the opportunity to engage with patients goes beyond using patient reported outcomes (PROs) and patient preference information (PPI) in regulatory decision-making.

According to Faris, patients should be engaged "at the very beginning when we're thinking about what technologies need to be developed in the first place" and when designing preclinical and clinical studies.

Challenges and Opportunities

Throughout the meeting, participants and members of the PEAC brought up a number of challenges and barriers that patients face with clinical trials.

One of the biggest challenges raised is that many patients are not all well-informed about how clinical trials work or how to get involved with them.

As a potential solution, PEAC members said that a framework or roadmap should be developed to demystify the clinical trial process for patients. The committee also said that information about clinical trials and informed consent documents should be written in plain language to make it easier for patients to understand.

As for enrolling patients, Annie Saha, director of external expertise and partnerships at CDRH, said that clinical trial sponsors should engage with the institutions that people trust to recruit patients. "Go to the churches, go to the nonprofits, use the local affiliates of the nonprofits, go to social clubs, go to local clinics, don't just try to use a primary care or academic medical center," she said.

Inclusion and exclusion criteria were also discussed as a challenge to patients. One PEAC member, Cynthia Chauhan, said that clinical trials "should reflect the affected population," noting that many minority groups are underrepresented in clinical trials and that restrictive inclusion and exclusion criteria can result in patients with comorbidities being left out.

When it comes to improving patient retention, PEAC members suggested reducing the frequency and length of visits, offering night and weekend hours to accommodate patients and their caregivers' schedules, offering child-care and providing transportation to and from the trial center would make it easier for patients to continue with clinical trials.

PEAC members also suggested ways to improve how information from clinical trials is communicated to patients, such as sending a patient newsletter and providing final trial results in an easy-to-read format.

2017 Meeting Materials of the Patient Engagement Advisory Committee

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