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Research provides valuable information that improves patients’ outcomes and should inform clinical decision-making.1 There are many research methodologies2 and randomised controlled trials (RCTs) are at the top of the hierarchy, providing the most robust results when efficacy of interventions is concerned.3 RCTs are considered the gold standard because randomisation is the best method we have to remove selection bias between two groups of patients. However, to randomise participants in a trials, there has to be genuine uncertainty in the clinicians over whether a treatment will be beneficial.4 This is called clinical equipoise, which provides the ethical basis for medical research that involves assigning patients to different treatment arms of a clinical trial.5
Notwithstanding all these considerations, it is well recognised that many RCTs struggle to recruit an adequate sample size, with large, collaborative studies often not being able to meet the targets as originally planned. Difficulty …
Contributors HJ drafted the manuscript and AC critically revised it.
Funding AC is supported by the National Institute for Health Research (NIHR) Oxford Health Biomedical Research Centre (grant BRC-1215-20005), by an NIHR Research Professorship (grant RP-2017-08-ST2-006) and by the NIHR Oxford Cognitive Health Clinical Research Facility.
Disclaimer The views expressed are those of the authors and not necessarily those of the UK National Health Service, the NIHR or the UK Department of Health.
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.
Patient consent for publication Not required.
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