Patient Engagement in Device Trials: FDA Drafts Guidance

Regulatory NewsRegulatory News | 23 September 2019 |  By 

The US Food and Drug Administration (FDA) on Monday released new draft guidance explaining how sponsors can improve the design and conduct of medical device clinical investigations by using patient experience, perspectives and other relevant information.

The 10-page draft mainly addresses four questions:
  1. What approaches might sponsors use to engage patient advisors (defined by FDA as those who have dealt with or are dealing with a particular condition but are not involved in clinical trials) to inform the design and conduct of device clinical investigations?
  2. When can input be gathered from patient advisors and incorporated into the clinical investigation?
  3. What are the roles of IRBs and other institutional groups in patient engagement?
  4. How can a sponsor receive feedback on its patient engagement plan or patient­-centered study design from FDA?
Among the approaches that could be useful, the agency points to discussing with patient advisors their views on which potential endpoints are clinically meaningful and how sponsors can work with patient advisors to inform the design of a patient preference study to better understand the benefit-risk tradeoffs.

“In more established areas, patient advisor input on draft protocols may translate into time and cost-saving improvements that also make the design more patient-centric. Such input should generally be incorporated before the final protocol and informed consent documents are submitted to the IRB for review,” the draft says.

FDA also notes that most engagement activities with patient advisors primarily involve interaction in a consultative or advisory capacity, so the agency does not generally consider these activities to fall under FDA’s regulations.

On the last question, FDA also says that it’s open to discussing patient engagement approaches through an informational meeting via its Q-Submission program.

“FDA believes effective patient engagement can help mitigate some of the practical challenges to robust clinical investigations, including challenges concerning study/research participant enrollment and retention in the study,” the draft adds.

Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations: Draft Guidance


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