The US Food and Drug Administration (FDA) has released draft guidance on patient engagement in the design and conduct of medical device clinical investigations.
The document details the agency’s proposed recommendations for manufacturers when working with patients in multiple aspects of an investigation, such as patient preference study design, benefit-risk determination and device labelling.
The draft is a direct result of the first Patient Engagement Advisory Committee (PEAC) meeting, which recommended the FDA work with industry to develop a framework to clarify how patient advisors can engage in the clinical investigation process.
PEAC is an advisory committee made up of patients, caregivers and their representatives, which works with the FDA Center for Devices and Radiological Health to encourage the inclusion of the patient perspective across the medical device life cycle.
FDA acting commissioner Norman Sharpless said: “We are committed to keeping patients, their families and caregivers at the centre of our work and to deepening their involvement in how we review medical device applications.
“Patient experiences and insight can help us understand the benefits most important to patients and what risks patients may or may not be willing to tolerate.”
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The draft proposal suggests that patient advisers should draw from personal experience living with a disease or condition to give advice on clinical investigation design or conduct, but will not be classed as participating in the investigation themselves. For example, they may advise device developers on how to improve informed consent documents so patients are able to understand the information presented to them more easily, or explain which endpoints of treatment are clinically meaningful to them.
The draft guidance is intended to build on the Patient and Caregiver Connection program established by the FDA in 2018. The program provides a formal process for FDA reviewers to engage with patients and patient organisations when evaluating a medical device.
Sharpless said: “Patient-centric clinical investigations may improve efficiency and quality in the design and conduct of clinical investigations, ensuring that sponsors can enrol and retain patients and collect information that is more meaningful to patients. This may lead to greater uptake of results by patients and providers when making treatment decisions and, ultimately, to earlier US patient access to innovative, safe and effective medical devices.”