Data and Safety Monitoring Board and the Ratio Decidendi of the Trial

Abstract

Current decision-making by a Data and Safety Monitoring Board (DSMB) regarding clinical trial conduct is intricate, largely limited by cases and rules, and essentially secretive. Decision-making by court of law, by contrast, although also intricate and largely constrained by cases and rules, is essentially public. In this paper, I argue by analogy that legal decision-making, which strives for a balance between competing demands of conservatism and innovation, supplies a good basis to the logic behind DSMB decision-making. Using the doctrine of precedents in legal reasoning as my central analog will lead us to an analogy for much more systematic documentation and transparency of decisions in clinical trials. My conclusion is twofold: every DSMB decision should articulate a clear general principle (a ratio decidendi) that gives reason for the decision; and all such decisions should be made public. I use reported DSMB experiences of the Women’s Health Initiative Clinical Trials to illustrate my analogical