March 2, 2020

MDIC is seeking public comments on its Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials white paper in support of the Framework for Patient Input in Medical Device Clinical Trials that is set to be completed this year.

Developing patient-centered medical product trials has the potential to improve the patient experience in clinical trials, accelerate accrual, improve retention, improve data quality, and assure that the trials themselves are focused on outcomes that matter most to patients. As device manufacturers pursue patient engagement activities, they still need more specific information on how best to engage patients to collect and employ patient perspectives across the medical device lifecycle. In response to this need and building upon its pioneering work to advance the use of patient preference information in device development, MDIC’s Science of Patient Input Steering Committee produced this white paper focused on methodologies to maximize patient participation in medical device clinical trials. This white paper aims to be a useful resource for all of MDIC stakeholders, including researchers, regulators, clinicians, and patients.

The Framework for Patient Input in Medical Device Clinical Trials will advance methods to integrate patient input into the design of clinical trials, advance a transformative method for integrating patient preferences into the statistical design of clinical trials, and synthesize practical considerations for reducing the patient burden of participation in clinical trials. It will develop and emphasize evidence-based tools for engaging with patients in the design of clinical trials.

View the white paper here.

The public comment period is open from March 2 – May 1, 2020.

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