Device Group Report on Patient Input

The Medical Device Innovation Consortium, of which FDA is a member, has released a new report entitled Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials. The report examines opportunities that exist for patient input to help define unmet need, clarify patient preferences, develop endpoints that measure what matters to patients, assist in reducing burdensome study protocol requirements to enhance recruitment and retention, and establish information that can be used in the regulatory process and for postmarketing activities. It also provides information and resources that can be used to assist device makers in “evaluating and building needed organizational capacity to successfully pursue patient engagement in clinical development,” the group says.

Patient engagement should be viewed as a continuum that occurs in different ways, for different purposes, across the lifecycle of the product development path. “Successful engagement with patients within clinical development requires a clear definition of what the patient’s role will be, from providing them a proactive, governance-type of ‘seat at the table’ with the study team, to engaging them as advisors, to offering a more reactive role,” the consortium says. The report also encourages device sponsors to take the time and make the effort to build relationships with patient groups and individual patients that are based on shared commitment to the effort, clear expectations, regular communications, and a common language about the project. “Avoiding the perception that engagement activities are tokenism and are just being done to ‘check a box’ by ensuring that all parties feel respected and able to contribute within the process is a key component of making this process meaningful,” it says.