USA – Patient preference information: Researchers offer insights on medical device clinical trial design

The US Food and Drug Administration (FDA) has increasingly called for the inclusion of patient preference information (PPI) to inform its regulatory decision-making for medical devices. A recently published report offers insights on the opportunities to leverage PPI, such as how to maximize stakeholder engagement, identifying novel endpoints and statistical considerations.

The article, published in Therapeutic Innovation & Regulatory Science on 27 August, looks at recent advancements in the use of PPI for medical device development, including lessons learned by industry, regulators and other stakeholders from the Medical Device Innovation Consortium’s (MDIC) patient preference information in the design of clinical trials (PPI-CT) framework.

MDIC is a public-private partnership between the FDA, industry, patient advocates, academia and other stakeholders aimed at advancing the regulatory science behind medical device and diagnostics development. The group has been influential over the past decade in working with the FDA to develop new regulations in using patient preference data for regulatory uses…