Medical device clinical trial growth in size and complexity are well-documented burdens to clinical research conduct, regulatory review, and access to new medical technologies. The Medical Device Innovation Consortium (MDIC) has proposed a pathway to support industry and regulatory agencies in the transformation towards greater clinical trial efficiency. Leveraging FDA guidance for the use of Bayesian statistics in medical device clinical trials, MDIC has created the Virtual Patient statistical model, which forward leverages historical information into prospective clinical trials. The model creates potential for smaller, faster and more cost-efficient clinical trials. Incorporation of prior knowledge in clinical trial design benefits patients by reducing burden; decreasing study size and trial length; and maintains scientific rigor. Shifting clinical trial culture to more efficient and effective practices improves innovative technology access for providers and patients alike.
Current as of October 29, 2019