Early Feasibility Studies Metrics Collection 2017 and 2019
By 2009, the U.S. had seen a significant decrease in the percent of clinical trials being conducted for medical technologies. FDA/CDRH recognized that medical devices, in contrast to a pharmaceutical, may require modifications on a near constant basis. In 2013, FDA/CDRH released the guidance on Early Feasibility Studies (EFS).
In 2017, MDIC worked with sponsors to analyze EFS performance metrics in the first ever collaborative sharing of Sponsor administrative data. Thirteen study sponsors provided data to MDIC to compile EFS Performance Metrics. Analysis of the metrics demonstrated that although most EFS IDEs were approved in the first 30-day review cycle, administrative challenges were the largest barriers to clinical trial operations. Times to IRB approval, contract approval, and first subject enrollment were all higher than 60 days each. The average time from the site packet received at the site to first patient enrolled was 320 days.
In the summer of 2019, MDIC repeated the exercise of gathering EFS performance metrics from sponsors to see how the landscape had evolved. Sponsors provided data from nine Early Feasibility Studies conducted at 60 sites. The recent data shows some improvement in time to IRB approval and first patient enrollment, resulting in a reduction of 2 months from when the site gets the packet to first patient enrollment. However, the total average time of approximately eight months greatly exceeds MDIC’s target of four months. Additionally, contract and budget negotiations between sites and sponsors are still a challenge and need improvement.