MDIC releases first of three resources that will be part of its Framework for Patient Input in Medical Device Clinical Trials


MDIC is seeking public comments on its Best Practices for Communicating Benefit, Risk and Uncertainty white paper in support of the Framework for Patient Input in Medical Device Clinical Trials that is set to be complete next year.

MDIC’s Science of Patient Input Steering Committee has worked to understand the best methods to assess patient preferences for benefit and risk in new technologies. As the Committee worked to identify the best methods for assessing patient preferences, they realized there was also a significant need to understand the best evidence-based practices to effectively communicate the benefits, risks and uncertainty of medical technologies to patients and providers. 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.  Additional resources will be released this fall for public comment, all in support of this larger framework.

View the white paper, here.

The public comment period is open from August 12 – September 13, 2019.

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