EFS Administrative & Clinical Practices: MDIC Working Group

MDIC, in collaboration with our member working group participants, held its Kickoff Meeting for Early Feasibility Study (EFS): Administrative & Clinical Practices on March 6, 2017. This working group initially (A) assessed EFS efficiency through the collection and dissemination of an EFS Performance Metrics Baseline, and subsequently (B) initiated the development of EFS Best Practices and Tools for both sponsors and sites. In 2018, MDIC continued partnering with sponsors and clinical sites to launch an EFS Site Demonstration Pilot.

In this demonstration pilot, MDIC serves as a conduit, connecting EFS sponsors and sites toward the following goals:

1. Provide EFS tools to study sponsors and sites
2. Collect metrics on EFS tool implementation and impact
3. Disseminate collected metrics and identified trends
4. Update EFS tools and best practices to further facilitate U.S. patient “First-in-World” access to innovative medical technologies