Trial protocols: time for more than tinkering

doi:10.1136/bmj.330.7488.421-b

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 includea trial protocol when submitting research papers for publicationseems reasonable to expose deviations from the original protocol.¹However, Abbasi and Jones's comment that "identifying deviationfrom the protocol is another important step in ensuring thatthe 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 genuinedifference to the reliability of data from clinical trials?Despite the many attempts to address the poor quality of reportingof trials, studies suggest that there has been little improvementin the standard.^2
3

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

James Penston, consultant physician

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