Abstract
In this commentary, we discuss a recent article in Trials that raised concerns about the number of poorly performed randomised trials in the medical literature and discuss the trials literature more widely. Although we all aim for higher methodological standards in trials, we argue that (i) the idea that ‘most randomised trials are bad’, which the recent article concludes is an overly simplistic representation of the situation, and (ii) the suggestion that an increased focus on methodological review during trial development (e.g. ethical boards performing some assessment of the methodologists on a trial), while well meaning, may have negative unintended consequences. We therefore propose that (a) trials should be assessed on their merits and weaknesses, including an assessment of risk of bias but placing that in a wider context; (b) we should recognise that although the methodological conduct of trials is of utmost importance, interventions that aim to improve this could have unintended consequences—such as bureaucracy—that have an overall negative effect; and (c) we should therefore generate an evidence base for policy interventions to improve conduct of trials rather than applying arbitrary rules.
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Details
; Arnold, David 2 ; Lilford, Richard 3 1 North Bristol NHS Trust, Infection Science, Southmead Hospital, Bristol, UK (GRID:grid.418484.5) (ISNI:0000 0004 0380 7221); University of Bristol, MRC Integrative Epidemiology Unit, Oakfield House, Bristol, UK (GRID:grid.5337.2) (ISNI:0000 0004 1936 7603)
2 University of Bristol, MRC Integrative Epidemiology Unit, Oakfield House, Bristol, UK (GRID:grid.5337.2) (ISNI:0000 0004 1936 7603); North Bristol NHS Trust, Academic Respiratory Unit, Southmead Hospital, Bristol, UK (GRID:grid.418484.5) (ISNI:0000 0004 0380 7221)
3 University of Birmingham, NIHR ARC West Midlands, Institute of Applied Health Research, College of Medical and Dental Sciences, Birmingham, UK (GRID:grid.6572.6) (ISNI:0000 0004 1936 7486)




