Medical Device Clinical Trial Design, Conduct, And Analysis

The collection and evaluation of sound clinical data are the basis of the approval process for many medical devices. This paper outlines those topics that a sponsor must carefully consider in an effort to provide a meaningful evaluation and interpretation of clinical data in support of medical device Premarket Approval applications PMA). The goal of a good clinical study is to provide the most objective evaluation of the safety and effectiveness of the medical device for its intended claims. Anything in the design, conduc4 or analysiswhich impairs that objective assessment lessens the ability of the staff at the Food and Drug Administration (FDA) and their advisory committees to make a decision concerning a 'reasonable assurance of safety and effectiveness' for a device. The cost of decisions in the design, conduct, and analysis of device clinical studies which limit objectivity must be weighed against the cost of delays in the approval process encountered as a result of those decisions. This paper provides the elements of good clinical trial design, conduct, and analysis. It is by no means exhaustive. Numerous books exist on the topic of clinical trial design and the scientific literature is rich with papers on the topic.