Intended for healthcare professionals


Patients who are eligible but not randomised should be included as additional comparative arm in study

BMJ 1999; 318 doi: (Published 27 March 1999) Cite this as: BMJ 1999;318:874
  1. L Peter Fielding (, Director, surgical services,
  2. Roger Grace, Director,
  3. Rosemary Hittinger, Senior clinical audit coordinator
  1. York Health Surgical Services, 1001 South George Street, York, PA 17405, USA
  2. Division of Clinical Science, University of Wolverhampton, Wolverhampton WV1 1SB
  3. Department of Clinical Audit, Acrow Building, St Mary's Hospital, London W2 1NY

    EDITOR—Peto and Baigent state that we need to find ways of making trials much simpler and larger.1 We agree and have a suggestion based on 20 years' experience.2

    Everyone is familiar with inclusion and exclusion criteria for randomised controlled trials. With rare exceptions, however, those patients who are eligible but not randomised are a forgotten part of the population; this presents a potentially large problem for all trials. The principal investigators of randomised controlled trials often find that the number of patients …

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