title: Who's minding the data? Data Monitoring Committees in clinical cancer trials.
abstract: Modern biomedicine is based on a number of novel institutions and practices that, in order to function, require some degree of formal and informal regulation. This paper contributes to the ongoing investigation of these processes, and the forms of objectivity they generate, by examining the emergence, development and deployment of Data Monitoring Committees in the field of clinical trials. The idea of a DMC had originally been raised in the clinical trial methodology literature in the 1970s so as to solve the problem of the management of interim trial data. Many leading clinical trial statisticians proposed that interim data and analyses be restricted to members of a DMC. Since the late 1980s, DMCs have evolved considerably in a constant search for ethical neutrality and objectivity through the use of sophisticated statistical techniques and novel organisational strategies. They have also been beset by a fundamental tension as to who or what should count as objective in such an undertaking. The paper examines the evolution of this institution in terms of the techniques brought to bear on the issues that they are expected to solve, the organisational forms through which DMCs have evolved and the ideals of objectivity that these forms embody.
authors.affiliation: Department of History, University of Quebec, Canada.
authors.forename: Peter
authors.initials: P
authors.lastname: Keating
authors.forename: Alberto
authors.initials: A
authors.lastname: Cambrosio
mesh_terms: D035843:Biomedical Research; D001699:Biometry; D026661:Clinical Trials Data Monitoring Committees / Q000266:history / Q000458:organization & administration*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D049673:History, 20th Century; D006801:Humans; D019451:Information Management / Q000458:organization & administration*; D009369:Neoplasms