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Results from Many Large Clinical Trials Remain Unpublished Years Later

Will Boggs MD  |  May 9, 2019

“In reviews of the literature, [physicians] should be looking for information about what research was done but never reported,” he said. “The registration of studies at least provides the ability to have a sense of the magnitude of what is kept from the public eye.”

The editorial, co-authored by Dr. Joshua D. Wallach, suggests, “Several potential approaches may be taken to ensure that clinical trial results become publicly available. First and foremost, nonreporting should be considered academic misconduct. Institutions should suspend investigators who do not report results within a year of finishing a trial, unless extenuating circumstances exist that impede reporting. These institutions also should consider lack of reporting in the academic promotion process.”

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“Funding agencies, such as the NIH, should withhold support from researchers who fail to report results,” they write. “Investigators who have completed clinical trials without reported results should be prohibited from applying for additional grants, and their current grants should be suspended. An even stronger incentive would be to hold institutions accountable for reporting results.”

“Lastly,” they conclude, “the public must be made aware of the ongoing gaps in the reporting of clinical trial results by dissemination of a list of completed clinical trials without reported results. Together, these efforts may ensure that all stakeholders in clinical research fulfill their ethical obligations to trial participants.”

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References

  1. Tatsioni A, Karassa FB, Goodman SN, et al. Lost Evidence From Registered Large Long-Unpublished Randomized Controlled Trials: A Survey. Ann Intern Med. 2019 May 7.  [Epub ahead of print]
  2. Wallach JD, Krumholz HM. Not Reporting Results of a Clinical Trial Is Academic Misconduct. Ann Intern Med. 2019 May 7. [Epub ahead of print]

 

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Filed under:Clinical Criteria/GuidelinesEducation & Training Tagged with:ClinicalTrials.govrandomized controlled trials (RCTs)unpublished clinical trial results

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