Summary

People who take part in clinical trials do not often get to know the results. Recently, there has been some discussion on how this could be remedied. A new study shows that participants valued getting personalized, accurate information about how the trial went shortly after findings were publically released.

Introduction

Volunteers for clinical research are always prepared carefully for the experience and looked after well during the trial. But, at the end, they do not have any particular right to know the results of the work they have contributed to ' even though they may have exposed themselves to risk in the hope that they and others might benefit from a new advance. Some researchers have suggested it would be more ethical to provide the participants with the results, be they positive or negative.

What was done

A team at the University of Rochester Medical Center carried out a study on the communication of clinical trial results. The participants had taken part in a trial of omega-3 fatty acids for mild to moderate Huntington's disease. After the trial was completed, the researchers compiled a communication plan with three elements ' a conventional press release posted online, a call from one of the researchers to participants, and a conference call between investigators, sponsors and study participants two weeks after the results were actually released. Participants were asked for their views on how the results were communicated.

What was found

Of the 114 participants who responded, 89 percent declared themselves satisfied with the conference call and 81 percent with the telephone call. But only half were impressed with the press release. Most said they had a good understanding of the risks and benefits of the experimental treatment. Nearly 60 percent said they would like the results to be reviewed before being revealed to them, even if this meant a delay. And a majority appreciated communications being addressed to them personally rather than to the public or investors of the company carrying out the trial.

What this study means

The role of the participant in a clinical study does not end when the last piece of data has been collected. They play a vital role which should be further acknowledged. One way forward is to communicate the results, as was done in this study, in a personalized way.

Source

Dorsey ER Beck CA Communicating clinical trial results to research participants Archives of Neurology December 2008;65:1590-1595