Why the ‘gold standard’ of medical research is no longer enough

Randomized controlled trials have long been held up as the “gold standard” of clinical research. There’s no doubt that well-designed trials are effective tools for testing a new drug, device, or other intervention. Yet much of modern medical care — perhaps most of it — is not based on randomized controlled trials and likely never will be. In this “dark matter” of clinical medicine, past practices and anecdotes all too often rule. We need to look beyond trials to improve medical care in these areas. In a randomized controlled trial (RCT), participants are randomly assigned to receive either the treatment under investigation or, as a control, a placebo or the current standard treatment. The randomization process helps ensure that the various groups in the study are virtually identical in age, gender, socioeconomic status, and other variables. This minimizes the potential for bias and the influence of confounding factors. Despite their strengths, RCTs...