title: Communicating clinical trial results to research participants.
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.
  
  
  METHODS
  Postal survey to research participants at 28 of 41 research sites (including 217 of 316 participants) in Canada and the United States.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Neurology, University of Rochester Medical Center, 1351 Mt Hope Ave, Ste 223, Rochester, NY 14620, USA. ray.dorsey@ctcc.rochester.edu
authors.forename: E Ray
authors.initials: ER
authors.lastname: Dorsey
authors.forename: Christopher A
authors.initials: CA
authors.lastname: Beck
authors.forename: Mary
authors.initials: M
authors.lastname: Adams
authors.forename: Gary
authors.initials: G
authors.lastname: Chadwick
authors.forename: Elisabeth A
authors.initials: EA
authors.lastname: de Blieck
authors.forename: Colleen
authors.initials: C
authors.lastname: McCallum
authors.forename: Leslie
authors.initials: L
authors.lastname: Briner
authors.forename: Lisa
authors.initials: L
authors.lastname: Deuel
authors.forename: Anthony
authors.initials: A
authors.lastname: Clarke
authors.forename: Rick
authors.initials: R
authors.lastname: Stewart
authors.forename: Ira
authors.initials: I
authors.lastname: Shoulson
mesh_terms: D035843:Biomedical Research / Q000379:methods; D002986:Clinical Trials as Topic; D003142:Communication; D004311:Double-Blind Method; D004345:Drug Industry; D005069:Evaluation Studies as Topic; D006801:Humans; D006816:Huntington Disease / Q000628:therapy; D010358:Patient Participation / Q000523:psychology; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000523:psychology*