Version 2.5.2.0

Abstract

Grant Number:	1R01LM005983-01A1
Project Title:	RANDOMIZED CLINICAL TRIAL 1946-1970

PI Information:	Name	Email	Title
	MELDRUM, MARCIA L.	meldrum@histr.sscnet.ucla.edu

Abstract: DESCRIPTION (adapted from the Abstract): 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.

Public Health Relevance:
This Public Health Relevance is not available.

Thesaurus Terms:
clinical trial, computer data analysis, data collection methodology /evaluation, health science research analysis /evaluation, publication
analgesic, contraceptive, poliomyelitis vaccine
human data

Institution:	INDIVIDUAL AWARD--MELDRUM, MARCIA L.
	1734 BROCKTON AVE, #106
	LOS ANGELES, CA 900253890
Fiscal Year:	1997
Department:
Project Start:	01-FEB-1997
Project End:	31-JUL-1998
ICD:	NATIONAL LIBRARY OF MEDICINE
IRG:	ZRG5

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