BMJ  2004;329:1360 (11 December), doi:10.1136/bmj.329.7479.1360

Editorial

Trial protocols at the BMJ

Authors must submit the protocol with the trial

The first 150 words of the full text of this article appear below.

Moves to improve the conduct and reporting of clinical trials have gathered pace this year. One issue that the BMJ has long grappled with is what to do about protocols of trials, and we announce a new policy that begins in January 2005.

Medical research should begin with a protocol that details the hypothesis, objectives, and methodology to be used in the study. Ideally the study should not deviate from the protocol, but in reality it often does. Sometimes deviating from the protocol is unavoidable—for example, when new evidence is published independently during the trial which invalidates the specified outcome. In other instances, protocol deviation may represent suppression of unfavourable findings in favour of reporting favourable ones.

Evidence of bias has been limited to case reports,^{1 2} but now we have research that begins to quantify the problem.^3-5 Chan et al compared the completeness of outcomes reported in protocols versus . . . [Full text of this article]

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This article has been cited by other articles:

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Time for more than tinkering

James Penston
bmj.com, 17 Dec 2004 [Full text]

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