FDA is looking for solutions to improve patient involvement in medical devices clinical trials

The US Food and Drugs Administration (FDA) held last week, the first meeting of its Patient Engagement Advisory Committee. During this meeting, the FDA and public speakers representing patients, research organisations or industry discussed on the topic of patient involvement in medical devices clinical trials.  The meeting purpose was to find solutions to improve patients participation in medical devices clinical trials, by incorporating their perspective when designing the studies.  Topics included patient recruitment, enrolment, retention, and communication of results.

One of the biggest barriers to patient participation in trials described is the lack of information.  According to the committee efforts should be made to de-mystify the process and simplify the access to information on clinical trials.  In order to improve patient recruitment and retention, the committee agreed that patients’ education is a key.  Patient materials should use simple language, pictures and videos.  The outcomes for the patients and the duration of the trial must also be clear.

To improve enrolment and increase the diversity of participants, partnership with patients groups, physicians and organisations should be envisaged, as well as the use of more flexible inclusion/exclusion criteria.

On the improvement of retention, the committee suggests that the frequency and length of follow-up visits should be minimised and that means that would make it easier for the patient to stay in the trial  should be offered (e.g. providing accommodation, travel compensation, child-care…).

Communication of clinical trial results to patients is also important to keep them involved in clinical research.  The communication must be easily accessible and easy to read.

Click here to access the meeting summary.

Meeting materials from FDA and other parties are accessible on the FDA website here.