Patient Input in Clinical Trial Design

New initiative: Framework for Patient Input in Clinical Trial Design

The vision of the Medical Device Innovation Consortium (MDIC) Science of Patient Input (SPI) Steering Committee is to provide a venue for continued collaboration to advance the art and science of patient engagement in regulatory science, including advances in methodologies and tactical considerations for integrating the patient’s perspective and preferences in the design, clinical development and regulatory review of innovative medical technologies.

The MDIC SPI Committee proposes the development of a Framework for Patient Input in Clinical Trial Design with three complementary projects to integrate patient perspectives into the design and execution of medical device clinical trials

  • Methodologies to systematically identify outcomes that matter most to patients and establish these outcomes as primary or secondary endpoints for clinical studies
  • Guidelines to integrate patient preferences into the statistical design of clinical trials
  • Methodologies to maximize patient participation in clinical trials

More details coming soon!