Communicating Clinical Trial Results to Research Participants

Background Communicating clinical trial results to research participants is seldom accomplished in a timely or an effective manner. Objective To evaluate the effectiveness of a plan to communicate results in an industry-sponsored randomized controlled trial for Huntington disease. Design, Setting, and Participants Postal survey to research participants at 28 of 41 research sites (including 217 of 316 participants) in Canada and the United States. Intervention We communicated trial results by means of (1) a media release from the investigators within a day after a sponsor-issued press release; (2) a subsequent telephone call from the site staff to the participants; and (3) a conference call for research participants 2 weeks after the results were released. Main Outcome Measures Source and timing for learning study results and satisfaction with their communication. Results Of the 217 study participants surveyed, 114 (52.5%) responded. Most (73.1%) first learned the study results from their site's telephone call, and 46.3% learned the results within 1 day of the sponsor's press release. Participants reported high or complete satisfaction with the site telephone call (89.3%) and conference call (82.1%) but relatively low satisfaction with the sponsor's press release (50.0%). Most respondents reported good understanding of the risks and benefits of the experimental treatment and the next steps for their participation. Conclusion Surveyed research participants learned of the clinical trial results soon after public release and highly valued the personalized and accurate communication efforts by the study investigators.