Communicating clinical trial results to research participants

the Huntington Study Group TREND-HD Investigators

Research output: Contribution to journalArticle

22 Citations (Scopus)

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%) firstlearned 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.

Original languageEnglish (US)
Pages (from-to)1590-1595
Number of pages6
JournalArchives of Neurology
Volume65
Issue number12
DOIs
StatePublished - Dec 1 2008
Externally publishedYes

Fingerprint

Clinical Trials
Telephone
Research
Communication
Research Personnel
Huntington Disease
Canada
Industry
Randomized Controlled Trials
Outcome Assessment (Health Care)
Learning
Telephone Calls
Press Releases
Sponsor
Surveys and Questionnaires
Staff
Randomized Controlled Trial
Participation

ASJC Scopus subject areas

  • Arts and Humanities (miscellaneous)
  • Clinical Neurology

Cite this

Communicating clinical trial results to research participants. / the Huntington Study Group TREND-HD Investigators.

In: Archives of Neurology, Vol. 65, No. 12, 01.12.2008, p. 1590-1595.

Research output: Contribution to journalArticle

the Huntington Study Group TREND-HD Investigators 2008, 'Communicating clinical trial results to research participants', Archives of Neurology, vol. 65, no. 12, pp. 1590-1595. https://doi.org/10.1001/archneurol.2008.503
the Huntington Study Group TREND-HD Investigators. Communicating clinical trial results to research participants. Archives of Neurology. 2008 Dec 1;65(12):1590-1595. https://doi.org/10.1001/archneurol.2008.503
the Huntington Study Group TREND-HD Investigators. / Communicating clinical trial results to research participants. In: Archives of Neurology. 2008 ; Vol. 65, No. 12. pp. 1590-1595.
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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{\%}) firstlearned 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.",
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AU - the Huntington Study Group TREND-HD Investigators

AU - Dorsey, E. Ray

AU - Beck, Christopher A.

AU - Adams, Mary

AU - Chadwick, Gary

AU - De Blieck, Elisabeth A.

AU - McCallum, Colleen

AU - Briner, Leslie

AU - Deuel, Lisa

AU - Clarke, Anthony

AU - Stewart, Rick

AU - Shoulson, Ira

AU - Dorsey, E. R.

AU - Shoulson, I.

AU - Leavitt, B.

AU - Ross, C.

AU - Beck, C. A.

AU - de Blieck, E. A.

AU - Greenamyre, J. T.

AU - Hersch, S. M.

AU - Kieburtz, K.

AU - Marder, K.

AU - McCallum, C.

AU - Moskowitz, C.

AU - Oakes, D.

AU - Rosenblatt, A.

AU - Shinaman, A.

AU - Frucht, S.

AU - Marder, K.

AU - Moskowitz, C.

AU - Margolis, R.

AU - Shannon, K.

AU - Jaglin, J.

AU - Sanchez-Ramos, J.

AU - Guttman, M.

AU - Raymond, L. A.

AU - Decolongon, J.

AU - Como, P.

AU - Barbano, R.

AU - Zimmerman, C.

AU - Seward, A.

AU - Suchowersky, O.

AU - Higgins, D.

AU - Wojcieszek, J.

AU - Jog, M.

AU - Horn, C.

AU - M. Dubinsky, R.

AU - Martin, W.

AU - Feigin, A.

AU - Shannon, B.

AU - Morgan, John Christopher

PY - 2008/12/1

Y1 - 2008/12/1

N2 - 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%) firstlearned 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.

AB - 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%) firstlearned 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.

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DO - 10.1001/archneurol.2008.503

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