Clinical Trials

“The point here is that clinical trials do not occur in a vacuum – and when the environment in which trials are conducted and interpreted is so contentious, then these experiments, rather than settling controversies, may instead reflect and propel them. Consider the range of factors and pressures that structured the determination of the ‘meaning’ of ACTG 155 as well as that of its precursor, ACTG 106: the methodological (and jurisdictional) disputes between infectious-disease researchers and biostatisticians; activist demands for access to drugs, plus or versus activist conceptions of ‘good science’; the social construction of hype; the profound need experienced by patients, and the kinds of pragmatic decisions that patients and research subjects make in response to their immediate perceptions of their interests; the marketing strategies of pharmaceutical corporations and the incentive structures to which these companies respond; the complicated role of practicing physicians in interpreting the data produced by clinical trials; the politics of regulation and deregulation; and the distinctive character of regulatory science as practiced by expert advisory bodies. In such an environment – given these stakes – is it any wonder that the interpretation of key trial results is often up for grabs? AIDS trials are not unique in this regard, as studies of cancer trials make clear. But insofar as the participation of knowledge-empowered activists increases the number of claims-makers and alters the distribution of credibility among them, AIDS trials may be particularly inclined toward conflicting readings” (Epstein, 315). . . . “. . . a study’s ‘definitiveness’ is not given but is a negotiated outcome and one that may be actively resisted by some parties to the controversy” (334).