The FDA Amendments Act of 2007 (FDAAA) and the “Final Rule” define the global ethical obligation to report the results of all clinical trials within a reasonable timeframe. However, the lack of reporting of clinical trials is still a prominent issue, with potential implications for treatment decisions and patient care. Last month, The BMJ unveiled a new, regular feature that intends to publicise unreported trials to encourage their reporting. Brief summaries in this series, published once per week, will highlight individual, unreported trials, the results of which may have important clinical relevance.
‘Unreported trials of the week’ will be selected using TrialsTracker. Launched by the AllTrials campaign, this FDAAA compliance tracking tool tracks trials registered on ClinicalTrials.gov and those that breach the FDAAA. At the time of writing, this tool identified 35% of trials as having unreported results.
The weekly series has already gone live; the first feature described an unreported study on analgesics for postoperative pain following the extraction of wisdom teeth. The feature’s authors, Nicholas J DeVito and Ben Goldacre, hope that the series will spark productive discussions focussed on improving reporting rates.
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The post A new series from The BMJ highlights unreported trials appeared first on The Publication Plan for everyone interested in medical writing, the development of medical publications, and publication planning.