July 3, 2022

Should medicine leave the gold standard of randomized trials?

Is it an example of “medical monotheism”?

When you google “randomized controlled trials”, you find an abundance of news stories and government agency websites which describe them as the “gold standard” of medical research. Take, for instance, a recent press release from Johns Hopkins University: “They found that only 11 of the programs met the scientific ‘gold standard’ for reliability in the studies—using randomized clinical trials.”

However, the medical profession is far less confident. Adding to the chorus of researchers and clinicians is an article in The Lancet which calls for a more “ecumenical” and flexible approach to acceptable study designs.

David S Jones and Scott H Podolsky, both from Harvard Medical School, point out that randomized trials do not have a long history. The first one took place in 1948 and the first instance of describing them as the “gold standard” dates back to only 1982.

While RCTs are clearly useful, they argue that “ever-growing databases provided by electronic medical records” and personalised medicine may be eroding their status.

They describe a rigid insistence on RCTs as “medical monotheism”.  

“… the emergence of biomedicine within the monotheistic traditions of Europe and the Middle East imbued medicine with a commitment to universal truths, unitary paradigms, and a ‘single-minded approach to illness and care’. The idea of a gold standard, that there is one best way to do something, whether conduct clinical research, diagnose a disease, or treat a patient, emerges from this underlying commitment.”

But in a world where universal truths are fading and governments have abandoned the yoke of a financial gold standards, perhaps RCTs need to be dethroned as well. 

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