The history and fate of the gold standard

Abstract

For the past half-century, physicians and clinical researchers have remained confident that randomised controlled trials (RCTs) provide the most rigorous test of preventive, diagnostic, and therapeutic interventions. They are ubiquitously referred to as the “gold standard” of empirical biomedical investigation, to the point where this status is often presented as a self-evident starting point in diagnostic or therapeutic evaluation. However, this status has long been contested, ever more so now with the emergence of “big data”, randomised registry trials, and other modes of knowledge production in medicine.