The goal of the proposed project is the publication of a monograph based on the Principal Investigator's doctoral dissertation at the State University of New York at Stony Brook (1994): """"""""Departures from the design: The randomized clinical trial in historical context, 1946-1970."""""""" In this study, the Investigator employs the methods of historical and cultural analysis to examine the randomized clinical trial (RCT) as this methodology was applied to specific therapeutic problems in the 1950s and 1960s, using a case study approach. In the case studies and the analyses the Investigator addresses the production of objective knowledge from subjective evidence and the relationship between research and clinical practice; she shows that they are directly relevant to current questions regarding the evaluation of therapeutic methods and outcomes. Although the RCT is a subject of interest to physicians, health policy makers, biomedical researchers, historians, and social scientists, very little has been published on the history of this methodology. The three cases examined are the Salk polio vaccine field trials of 1954, the trials of barrier contraceptives and intrauterine contraceptive devices from the late 1950s and 1960s, and the comparative analgesics trials from the same period. These cases were selected on the bases of inherent interest, availability of archival materials, rich social context, and contemporary impact on medical practice. Research materials include medical literature, archival collections, and Food and Drug Administration records, copies of some of which were obtained under the Freedom of Information Act.
