Review of Clinical Trial Reporting Guidelines
Author Information
Author(s): Kerry Dwan, Carrol Gamble, Paula R Williamson, Douglas G Altman
Primary Institution: Centre for Medical Statistics and Health Evaluation, University of Liverpool
Hypothesis
How much guidance do research funders provide regarding the reporting of clinical trial results?
Conclusion
There is a need for more detailed guidance from research funders to prevent selective reporting of clinical trial outcomes.
Supporting Evidence
- Seventeen organizations and 56 charities were eligible for the review.
- Only 11 organizations mentioned the publication of negative outcomes.
- Three organizations specifically stated that the statistical analysis plan should be strictly adhered to.
Takeaway
This study looked at how well organizations guide researchers on reporting clinical trial results, and found that many don't provide enough help.
Methodology
A survey of major research organizations and UK charities was conducted to assess their guidelines on trial registration, protocol adherence, and publication.
Potential Biases
Limited awareness of outcome reporting bias among funders may lead to insufficient guidelines.
Limitations
The review was not exhaustive and focused mainly on organizations from Europe, USA, Australia, and South Africa.
Digital Object Identifier (DOI)
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