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BioMed Central to publish clinical trial protocols to raise the standards of medical research

BioMed Central

The publication of peer-reviewed protocols could potentially improve the standards of clinical trials by imposing scrutiny on research methods as well as having the additional benefit of boosting recruitment into trials.

By publishing protocols, BioMed Central is addressing a need identified by Iain Chalmers, director of the UK Cochrane Centre, and Doug Altman, of the ICRF Statistics Group in Oxford, for journals to play a more radical role in improving the standards of medical research. An editorial just published in BioMed Central (http://www.biomedcentral.com/1471-8219/2/4) details the ways in which publication of protocols will help to tackle what Altman has called the 'scandal of poor medical research'.

Briefly, the advantages of protocol publication are that it:

  • allows peer reviewers and readers to suggest improvements to draft protocols before a study begins.
  • allows comparison between what was originally intended and what was actually done, which reduces the potential for data dredging or for unacknowledged or inappropriate retrospective revision of the study aims, design, or planned analyses.
  • lets people know what studies are underway, so reducing wasteful duplication of research effort, making it easier for systematic reviewers to find studies, and boosting recruitment into trials.
  • helps to promote prospective registration of trials.
The online journals within BioMed Central provide open peer review, rapid publication (with an average time from submission to publication of 6 weeks), unlimited space, worldwide barrier-free dissemination, and the ability to link protocols to recruitment initiatives, trial reports, full data sets, and systematic reviews. They also provide, through PubMed and PubMed Central, a searchable and permanent record of the protocol for citation.

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To view examples of protocols published by BioMed Central visit:

http://www.biomedcentral.com/1471-2458/1/2 - A case control study of autism and MMR vaccination.

http://www.biomedcentral.com/1471-227X/1/1 - The CRASH trial, a multicentre randomised controlled trial of steroids in head injury.

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