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Clinical trial reporting ‘below an acceptable level’

Some of the world’s leading medical journals are trying to drive up standards in the reporting of clinical trials as a new analysis shows they are still not up to scratch.

Publications including the Lancet, the BMJ and PLOS Medicine have unveiled a new version of the Consolidated Standards of Reporting Trials (CONSORT) in a renewed attempt to deal with this problem.

This comes as an analysis of over 1,000 randomised trials published either side of the 2001 CONSORT statement shows some improvement, but warns that “the quality of reporting remains well below an acceptable level”. Important information about trials – such as sample seizes and primary outcomes – is still often missing from published papers, warn Sally Hopewell, of the University of Oxford, and her colleagues.

“Without complete and transparent reporting of how a trial was designed and conducted, it is difficult for readers to assess its conduct and validity or to differentiate trials with unbiased results from those with questionable results,” they write in the BMJ. “More journals should endorse the CONSORT Statement, and, most importantly, they should do more to ensure adherence.”

The CONSORT team describes the 2010 changes as “evolutionary, not revolutionary” from the previous 2001 iteration of the standards. They include simplified wording and more detailed provisions for authors to include, for example, summaries of their trial designs, methods, and results.


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