'Departures from the design': The randomized clinical trial in historical context, 1946-1970

摘要

The randomized clinical trial (RCT), a methodology based on statistical theory, is the dominant method used by modern American medicine to evaluate therapeutics. Since the 1940s, it has achieved considerable resonance and authority in the medical community as the scientific standard for clinical practice. Its status continues the long scientific tradition of reliance on correct method to define objective, value-free knowledge. The dissertation examines the history of the RCT between 1946, when the method was well defined in the literature, and 1970, when the Food and Drug Administration adopted it as the regulatory standard for the evaluation of pharmaceuticals. Three case studies are presented: the Salk polio vaccine trials of 1954, sponsored by the National Foundation for Infantile Paralysis; the trials of barrier contraceptives and intrauterine contraceptive devices, sponsored by the Planned Parenthood Federation of America and the Population Council from 1959 to 1968; the refinement of the RCT model to deal with the problems of pain and analgesia by a group of Harvard researchers in the early 1950s and the attempts by the FDA and the medical community from 1957 to 1970 to evaluate the analgesic Darvon.;In my analysis of these historical cases, I argue that the RCT in practice is not a methodological black box but a social exercise in problem solving, involving the interaction of social actors: organizational sponsors, medical researchers, and patient subjects. Each group of actors has a unique definition of the social-medical problem to which the trial is designed to provide a solution. The outcome of the trial is not value-free data, but a social construction; the randomized clinical trial is a social process. In particular, I argue that patients play a critical role, which researchers often ignore or attempt to neutralize, in the trial process. I demonstrate that the explicit result of the RCT may not translate into clinical practice, whereas the social, tacit result will affect the historical outcome. Finally, I argue that organizations in this period successfully employed the RCT methodology to legitimize their own scientific authority; in doing so, they contributed to the validation of the method as a standard for such authority.