MDICx: Early Feasibility Studies Best Practices: Lessons Learned from Sites Achieving "60/60/60"

MDIC has launched a collaborative initiative in support of the FDA’s Early Feasibility Studies (EFS) program to expedite US patient access to novel devices and therapies of significant health importance. The EFS Initiative aims to remove barriers for efficiently conducing EFS in the United States by creating a network of sites and sponsors committed to using available EFS tools, meeting performance goals, and creating a learning environment where best practices are shared. This commitment enables sites to pursue and achieve the “60/60/60” goal, which is defined as the time to a) execute the EFS Clinical Trial Agreement, b) achieve IRB approval, and c) enroll the first patient.

To support this effort, representatives from two different sites from our EFS Site Network Pilot will share their best practices and lessons learned for achieving the “60/60/60” goal. Each of the presentations will describe the struggles faced when running the first EFS at their institution, the processes put into place, and how the institution has managed to achieve the “60/60/60” goal.

Speakers:

Chip Hance, MDIC Board Champion for the EFS Initiative
Necole Kell BS, RN, Clinical Research Supervisor, Baylor Scott & White Research Institute at The Heart Hospital Plano
Beth Wilson, KCVI Clinical Research Manager at Oregon Health and Science University (OHSU)