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."
(Arch Neurol. 2008;65[12]:1590-1595. Available pre-embargo to the media at

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

The JAMA Network Journals

Related Clinical Trials Articles from Brightsurf:

Nearly 1 in 5 cancer patients less likely to enroll in clinical trials during pandemic
A significant portion of cancer patients may be less likely to enroll in a clinical trial due to the ongoing coronavirus pandemic.

COVID-19 clinical trials lack diversity
Despite disproportionately higher rates of COVID-19 infection, hospitalization and death among people of color, minority groups are significantly underrepresented in COVID-19 clinical trials.

Why we should trust registered clinical trials
In a time when we have to rely on clinical trials for COVID-19 drugs and vaccines, a new study brings good news about the credibility of registered clinical trials.

Inclusion of children in clinical trials of treatments for COVID-19
This Viewpoint discusses the exclusion of children from coronavirus disease 2019 (COVID-19) clinical trials and why that could harm treatment options for children.

Review evaluates how AI could boost the success of clinical trials
In a review publishing July 17, 2019 in the journal Trends in Pharmacological Sciences, researchers examined how artificial intelligence (AI) could affect drug development in the coming decade.

Kidney patients are neglected in clinical trials
The exclusion of patients with kidney diseases from clinical trials remains an unsolved problem that hinders optimal care of these patients.

Clinical trials beginning for possible preeclampsia treatment
For over 20 years, a team of researchers at Lund University has worked on developing a drug against preeclampsia -- a serious disorder which annually affects around 9 million pregnant women worldwide and is one of the main causes of death in both mothers and unborn babies.

Underenrollment in clinical trials: Patients not the problem
The authors of the study published this month in the Journal of Clinical Oncology investigated why many cancer clinical trials fail to enroll enough patients.

When designing clinical trials for huntington's disease, first ask the experts
Progress in understanding the genetic mutation responsible for Huntington's disease (HD) and at least some molecular underpinnings of the disease has resulted in a new era of clinical testing of potential treatments.

New ALS therapy in clinical trials
New research led by Washington University School of Medicine in St.

Read More: Clinical Trials News and Clinical Trials Current Events is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to