BMJ  2005;330:421 (19 February), doi:10.1136/bmj.330.7488.421-b

Letter

Trial protocols: time for more than tinkering

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

EDITOR—The BMJ's recent requirement that authors include a trial protocol when submitting research papers for publication seems reasonable to expose deviations from the original protocol.¹ However, Abbasi and Jones's comment that "identifying deviation from the protocol is another important step in ensuring that the findings of a study are reported with honesty and transparency" rings hollow.

What are the other "important steps"? Is there, for instance, any evidence that such steps taken in the past have made a genuine difference to the reliability of data from clinical trials? Despite the many attempts to address the poor quality of reporting of trials, studies suggest that there has been little improvement in the standard.^{2 3}

In any case, compelling researchers to include their protocols will have no effect on their honesty. If people are dishonest and intent on committing research misconduct, then they will do so—preventing them from deviating from . . . [Full text of this article]

Scunthorpe General Hospital, Scunthorpe, North Lincolnshire DN15 7BH james.penston@nlg.nhs.uk

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