Data and Safety Monitoring Board and the Ratio Decidendi of the Trial
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 argument. More...
Other Recent Articles
Falsifiability Revisited: Popper, Daubert, and Kuhn
Mark Amadeus Notturno
The Supreme Court’s 1993 Daubert v. Merrell Dow Pharmaceuticals decision acknowledged a change in the Federal Rules of Evidence for the admissibility of expert scientific testimony in legal proceedings. Two of the most controversial aspects of the decision were the Court’s general comments about science, and its appeal to Karl Popper’s notion of falsifiability as “a key question to be answered in determining whether a theory or technique is scientific knowledge that will assist the trier of fact.” Indeed, Chief Justice Rehnquist acknowledged in his dissenting opinion that he did not know what falsifiability meant and that he thought other judges would not understand it either. This paper explains what Popper meant by falsifiability, why it has been misunderstood, why it is important today, and how the Court’s decision reflects the larger move from foundationalism to fallibilism that has taken place in epistemology over the course of the twentieth century. More...
Call for Papers
About the Journal
To learn more about the Journal click here.
JPSL articles are archived with the Philosophy Documentation Center.
Select articles are also available at the National Reference Center for Bioethics Literature.