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


Authors
Roger Stanev
University of Ottawa
Abstract
Decision-making by a Data and Safety Monitoring Board (DSMB) regarding clinical trial conduct and termination is intricate and largely limited by cases and rules. Decision-making by legal jury is also intricate and largely constrained by cases and rules. 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 a decision-theoretic analogy for much more systematic documentation 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 Bartha’s (2010) theory of analogical arguments to both frame and assess my argument by analogy.
Keywords clinical trials  legal reasoning  analogy  medical reasoning  decision-making  statistical inference  ethics  experiments  science and democracy  scientific inferece
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Reprint years 2015
ISBN(s) 1549-8549
DOI 10.5840/jpsl20151525
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References found in this work BETA

Making Things Happen. A Theory of Causal Explanation.James Woodward - 2007 - Philosophy and Phenomenological Research 74 (1):233-249.
The Concept of Law.Stuart M. Brown & H. L. A. Hart - 1963 - Philosophical Review 72 (2):250.
By Parallel Reasoning.Paul Bartha - 2009 - Oxford University Press USA.
Taking Rights Seriously.Ronald Dworkin - 1979 - Ethics 90 (1):121-130.

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