Unperceived similarities between clinical trials and quantum physics
Abstract
The randomized controlled trial (RCT) is the best design to determine cause-effect relationships in biomedical research. This is applicable to any other branch of science. When one compares two interventions (for example, medicines) in a RCT, the results (or observations) can be attributable only to the medicines, provided biases have been appropriately controlled. At the design stage, clinical equipoise is the first condition any RCT must comply with to be ethically acceptable. Clinical equipoise means that investigators do not know which medicine has a better benefit/risk ratio; in other words, there is a genuine uncertainty1 of their comparative efficacy or effectiveness.2 This has been proven to be true, since only slightly over 50% of 860 phase 3 RCTs have shown that new treatments were better than the comparators.3 Thus, at study start, results of all RCTs are unpredictable, uncertain, and indeterminate. Participants in a RCT can be subject to the Hawthorne effect. This refers to research participants' behavioural changes in response to their awareness of participating in a trial. The name comes from the manufacturing plant near Chicago in which several studies took place between 1924 and 1933, to assess the effects of lighting and breaks on the workers. It turned out that the workers' output increased during the studies, translating the effect that individuals changed their behaviour in response to being observed. In the Hawthorne effect, the observer (ie, the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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