“Do those results from elsewhere apply?”: How American regulators question the validity of clinical trials conducted “elsewhere”.

• In Event: Producing Transformations: Drugs, Bodies, and Experimentation 3

Abstract

STS scholars have highlighted how clinical trials employ strict protocols to produce “decontextualized” data and claim “universal” results. They have critically examined the transformations taking place “when experiments travel” to low resource settings, whether in Eastern Europe or the Global South. We extend this research, by investigating what happens when data produced in multi-sited clinical trials travels “back” to the Global North.
This paper is part of a larger project that examines what counts as knowledge in the e/valuation of new drugs at the Food & Drug Administration (FDA) in the USA. It relies on qualitative content analysis of verbatim transcripts of Oncology Drug Advisory Committee (ODAC) meetings. We examine how ODAC experts question the validity of data from clinical trials conducted outside North-America (mostly in Eastern Europe).
We show that some trials are rejected as unethical, or the quality of laboratory data is distrusted. However, discussions whether non-American trial subjects are “comparable” to American patients focuses mostly on whether ‘local’ or ‘American’ standards of care are incorporated into the trial. We will argue these debates can be interpreted as ODAC members questioning whether trials measure the drug to be tested, or the « local biologies » of trial subjects. Moreover, the debates over the comparability of trial subjects and American patients reveals that trial data must not only answer ‘which drug is best for patients?’, but also answer ‘who are the best patients for this drug?’.

Author

• Loes Knaapen, Université d'Ottawa