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.
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.