Clinical trial participants value personalized, accurate information about study results

December 08, 2008

Participants in clinical trials report being satisfied with personalized, accurate communication of results by study investigators soon after the study findings are released publicly, according to a report in the December issue of Archives of Neurology, one of the JAMA/Archives journals.

Even though volunteers in clinical trials expose themselves to risk, there is no legal mandate for investigators to inform participants of study results, according to background information in the article. However, many researchers have recommended providing both negative and positive clinical trial results as the "ethical norm." "Despite this recommendation, efforts to communicate results to research participants remain quite limited," the authors write. "Some participants never learn study results, although many would like to have that information."

E. Ray Dorsey, M.D., M.B.A., of University of Rochester Medical Center, New York, and colleagues conducted a multi-site randomized clinical trial of an omega-three fatty acid for patients with mild to moderate Huntington's disease. Following the completion of the trial, the researchers implemented a communication plan with three principal elements: a media release from the study investigators, posted online and e-mailed to members of the Huntington's disease community; a telephone call from the site staff to research participants; and a conference call for investigators, sponsor and study participants two weeks after the results were released.

A total of 217 study participants were mailed a survey to assess their satisfaction with the communication of the results; 114 (52.5 percent) responded. "Most (73.1 percent) first learned the study results from their site's telephone call, and 46.3 percent learned the results within one day of the sponsor's press release," the authors write. "Participants reported high or complete satisfaction with the site telephone call (89.3 percent) and conference call (82.1 percent) but relatively low satisfaction with the sponsor's press release (50 percent). Most respondents reported good understanding of the risks and benefits of the experimental treatment and the next steps for their participation."

When asked whether they prefer that results undergo a thorough review before being informed, 59.4 percent agreed, even if it meant a delay in learning about the results. They also reported preferring communications customized to them rather than directed to the public or company investors.

"Communicating research results to participants remains an unmet need that would likely benefit from more planning and cooperation, from addressing the issue prospectively in the consent process, and from using a more evidence-based appraisal of clinical research practices," the authors conclude. "Our study suggests that addressing this need is feasible and highly valued by research participants."
-end-
(Arch Neurol. 2008;65[12]:1590-1595. Available pre-embargo to the media at www.jamamedia.org.)

Editor's Note: The TREND-HD Study and the communications effort were supported by Amarin Neuroscience Ltd. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

For more information, contact JAMA/Archives Media Relations at 312/464-JAMA (5262) or e-mail mediarelations@jama-archives.org.

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