Schemata, CONSORT, and the Salk Polio Vaccine Trial.

In this essay, we defend the design of the Salk polio vaccine trial and try to put some limits on the role schemata should play in designing clinical research studies. Our presentation is structured as a response to de Freitas and Pietrobon (de Freitas, R. S. and R. Pietrobon. 2007. Whoever could get rid of the context of discovery/context of justification dichotomy? A proposal based on recent developments in clinical research. Journal of Medicine and Philosophy 32:25-42.) who identified the CONSORT statement as a schema that would have, had it existed at the time, ruled out the design of the Salk polio vaccine trial of 1954 in favor of a completely randomized controlled clinical trial (RCT). We argue that large-scale public health interventions often require evidence beyond simple efficacy, the limit of what an RCT can provide, and that the design actually adopted for the Salk trial represented a reasonable-albeit imperfect-compromise. This is of more than historical interest in that many contemporary studies are of the scale and scope to require a more pragmatic, rather than explanatory, approach to study design (Kowalski, C. J. 2010. Pragmatic problems with clinical equipoise. Perspectives in Biology and Medicine 53:161-73.).