Not Reporting Harm: CONSORT and Clinical Trials

In 2004 an extension to Consolidated Standards of Reporting Trials (CONSORT) to aid in the reporting of adverse events was published (see: Ioannidis JP. PubMed PMID: 15545678), but did it work? Are the studies published in leading medical journals doing a better job of reporting negative “side effects” in clinical trials? Not according to a new review published in the Archives of Internal Medicine.

In “Reporting of Safety Results in Published Reports of Randomized Controlled Trials,” Isabelle Pitrou and her co-authors conclude “that despite the publication of a CONSORT statement extension for harm-related data, the reporting of harm remains inadequate.” Not only did 18% of studies fail to provide numerical data about adverse events in each trial arm, but 27% did not include information about the severity of events while 47% failed to report adverse event related patient withdrawals from the trials.

In a related editorial, John P.A. Ioannidis laments the ongoing “plague” of poor reporting of adverse events in randomized trials. In addition to faulty study design and professional neglect, he also cautions against restricted reporting, intentional distortion of results (in the literature and the media), and even (in some conflicts of interest cases) the “orchestrated silencing of the evidence.”


Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med. 2009;169(19):1756-1761.  PubMed PMID: 19858432

Ioannidis JP. Adverse events in randomized trials: neglected, restricted, distorted, and silenced. Arch Intern Med. 2009;169(19):1737-1739. PubMed PMID: 19858427



John Gever. Spotty Reporting of Adverse Events Noted in Big-Name Journals. MedPage Today. October 26, 2009.

Karen Kaplan. What researchers don’t want you to know about their clinical trials. Los Angeles Times. October 26, 2009.

Other Research Ethics News

Ju-min Park. Disgraced cloning scientist Hwang Woo-suk guilty of embezzlement. Los Angeles Times. October 27, 2009.


Mark Henderson. Hwang Woo-suk’s cloning fraud has not set back stem cell research. Times Online. October 27, 2009.

David Cyranoski. Woo Suk Hwang convicted, but not of fraud. Nature News. October 26, 2009.

Stacy Battenberg. Group receives ethics research grant to protect human subjects. The Minnesota Daily. October 26, 2009.

Julie Steenhuysen. Risks to personalized medicine seen in U.S. reform. Reuters. October 26, 2009.

Duff Wilson. Research Uproar at a Cancer Clinic. The New York Times. October 22, 2009.

National Institutes of Health (NIH). Notice on Development of Data Sharing Policy for Sequence and Related Genomic Data. NOT-HG-10-006. October 19, 2009.

David Armstrong. New Conflict Rules at Medical Journals. The Wall Street Journal. October 14, 2009.

A Clear Line on Stem Cells. The Washington Post. October 10, 2009.

Simon Baron-Cohen. Studying autism genetics responsibly. BioNews. October 5, 2009.

– J. O.


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