Authors' objectives:

1. To review ethical arguments put forward in the literature which bear on randomised controlled trials (RCTs), focusing particularly on uncertainty as an underpinning issue.

2. To review empirical data (from comparative, observational and qualitative studies) which may be relevant to the ethics of conducting trials.

Authors' recommendations: The caring professions must articulate clear, ethical justification for trials if public confidence is to be retained. Patients should not lose out in prospect by taking part in a trial. Given treatments which are generally available, patients do not lose out in prospect when prior estimates of effectiveness and values interact to produce equal expected utilities. When treatments are not generally available, patients do not lose out by participating in trials when the expected utility of the new treatment is at least as high as that of standard treatment. The term 'uncertainty' prevaricates on prior probabilities and values, making it an inadequate moral basis for trials. It should not be used to disguise such existing data as may affect patient preferences, even when such data are insufficient to engender 'certainty'. Patients must be given as much information as they need to bring their values into play. Patients are least alarmed and understand the issues most clearly when they have encountered the concept of comparative trials before. Practitioners should pay particular attention to explaining abstract ideas (especially that of randomisation). Small trials of existing therapies are not necessarily unethical provided that they are in equipoise. Clinical trials should start early in the life of a new treatment. The idea that patients in trials do better than average, even when the trial produces a negative result, may be true. If the effect is real, it would seem to come from enhanced attention to detail inherent in following the trial protocol for both control and experimental groups. It should not, however, be used as an inducement to accept randomisation since the Helsinki accord requires that the intention should be to provide the 'best' care for all patients.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.hta.ac.uk/925

Year Published: 1998

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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