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

BMJ 1999;318:874 ( 27 March )

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

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EDITOR $---$ Peto and Baigent state that we need to find ways of making trials much simpler and larger.¹ We agree and have asuggestion 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 forgottenpart of the population; this presents a potentially large problemfor all trials. The principal investigators of randomised controlledtrials often find that the number of patients being entered intoa trial by a particular contributor is not related to the sizeof the population served by that doctor. There are many reasonsfor this: purported logistic problems of data entry, inconveniencefor patients, patients' unwillingness to accept randomisation,non-specific unsuitability of patients for the trial, etc. Thedoctor's inability or unwillingness to offer the trial to alleligible patients provides the circumstances in . . . [Full text of this article]

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Trials: the next 50 years: Richard Peto and Colin Baigent
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