Communicating clinical trial results to research participants

Arch Neurol. 2008 Dec;65(12):1590-5. doi: 10.1001/archneurol.2008.503.


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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biomedical Research / methods
  • Clinical Trials as Topic
  • Communication*
  • Double-Blind Method
  • Drug Industry
  • Evaluation Studies as Topic
  • Humans
  • Huntington Disease / therapy
  • Patient Participation* / psychology
  • Randomized Controlled Trials as Topic / methods
  • Randomized Controlled Trials as Topic / psychology*