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

Communicating clinical trial results to research participants.

Author information

  • 1Department of Neurology, University of Rochester Medical Center, 1351 Mt Hope Ave, Ste 223, Rochester, NY 14620, USA. ray.dorsey@ctcc.rochester.edu

Abstract

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.

PMID:
19064746
[PubMed - indexed for MEDLINE]
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