Session Details

Innovation in Clinical Trial Design to Reduce Trial Size
Monday, October 17, 2016 02:30 PM - 03:45 PM 
Key Health Policies
Panel Session
The growth in size and complexity of medical device clinical trials is a well-documented burden to clinical research and the regulatory review of new medical technology. The Medical Device Innovation Consortium (MDIC), a non-profit public-private partnership created to advance medical device regulatory science, has proposed a pathway to support industry and regulatory agencies in the transformation towards greater efficiency of clinical trials driven by innovation in design, operations and the regulatory process. Leveraging FDA guidance for the use of Bayesian statistics in medical device clinical trials, MDIC has created a framework to augment clinical trial design with virtual patients. The framework creates potential for smaller, shorter and more cost-efficient clinical trials. Incorporation of prior knowledge in clinical trial design benefits patients by reducing burden: decreased study size and trial length while maintaining the same study endpoints. Shifting the culture to advanced practices that make clinical trials more efficient and more effective will reduce the costs of clinical trials and potentially shorten the time to bring innovative technologies to the patients who need them.
Vicki Anastasi
Vice President and Global Head Medical Device and Diagnostics Research

Owen Faris
Director, Clinical Trials Program

Chip Hance
ACTP Board Champion

Rick Kuntz
Sr. Vice President and Chief Scientific, Clinical and Regulatory Off.

Randall Schiestl
Boston Scientific