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E. Ray Dorsey, MD, MBA; Christopher A. Beck, PhD; Mary Adams, MTS; Gary Chadwick, PharmD, MPH; Elisabeth A. de Blieck, MPA, CCRC; Colleen McCallum, MSW; Leslie Briner; Lisa Deuel, BA; Anthony Clarke, PhD; Rick Stewart, BS; Ira Shoulson, MD; and the Huntington Study Group TREND-HD Investigators

Arch Neurol. 2008;65(12):1590-1595.

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.

Author Affiliations: Departments of Neurology (Drs Dorsey and Shoulson) and Biostatistics and Computational Biology (Dr Beck), Research Subjects Review Board (Ms Adams), Office of Human Subject Protection (Dr Chadwick), Clinical Trials Coordination Center (Mss de Blieck, Briner, and Deuel), and Department of Psychiatry (Ms McCallum), University of Rochester Medical Center, Rochester, New York; and Amarin Neuroscience Ltd, London, England (Dr Clarke and Mr Stewart). Dr Clarke is now with Alexza UK Ltd, Henley-on-Thames, England; Mr Stewart is no longer with Amarin Neuroscience Ltd.

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