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Reporting of Trial Results by Top Academic Centers Remains Poor, Says Study


Pharmaceutical Executive

February 19, 2016.

Dissemination of clinical trial results by leading academic medical centers in the U.S. remains poor, despite ethical obligations-and sometimes statutory requirements-to publish findings and report results in a timely manner, according to a study in The BMJ this week.

Researchers led by Dr. Harlan Krumholz at Yale School of Medicine found that only 29% of completed clinical trials led by investigators at major U.S. academic centers were published within two years of completion and only 13% reported results on ClinicalTrials.gov. They think action is needed to rectify this lack of timely reporting and publication, “as they impair the research enterprise and threaten to undermine evidence-based clinical decision-making.”

The group examined rates of publication and reporting of results within two years for 4,347 registered trials completed between October 2007 and September 2010 across 51 leading U.S. academic institutions. Only 1,245 of the completed clinical trials were published within two years of study completion and only 547 reported results on ClinicalTrials.gov.

The study also revealed marked variations in rates of dissemination of clinical trial results across academic institutions, with more than a twofold variation in the average time from study completion to dissemination of results and more than a threefold variation in the rate of dissemination across institutions. No academic center published more than 40% of completed clinical trials within two years of completion or reported results for more than 41% of its studies.

“We found noticeable variation and poor performance across leading academic medical centers in the dissemination of clinical trial results,” write the authors, who point out that there is no effective enforcement mechanism and no repercussions to academic institutions or individual investigators for failing to report results.

“The lack of timely reporting and publication fundamentally impairs the research enterprise, violates the commitment made by investigators to patients and funders, squanders precious time and resources, and threatens to compromise evidence-based clinical decision-making,” they noted.

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