title: Meeting the obligation to communicate clinical trial results to study volunteers.
abstract: Although the overwhelming majority of study volunteers want to receive information on the results of their participation in clinical trials, research suggests that most study volunteers never do. CISCRP - an independent nonprofit organization - in collaboration with Pfizer, conducted a study evaluating the feasibility and impact of a new process to inform study volunteers of the results of their clinical trials. Two process components were evaluated via surveys, focus groups, and interviews with volunteers and investigative site staff: a series of ongoing post-trial communications to set expectations for when trial results would be received; and routine development and delivery of the lay language trial results summary. The results of this assessment show that study volunteers and investigative site staff are extremely receptive to receiving clinical trial results and that the process of preparing and disseminating clinical trial results is feasible and generally easy to execute. The results also indicate that study volunteer comprehension of basic facts about their clinical trial pre- and post-test increased by as much as 65.6 percentage points, and suggest that this communication initiative may positively impact volunteer recruitment, retention and long-term trust in the clinical research enterprise.
authors.affiliation: Tufts University, 75 Kneeland Street, Suite 1100, Boston, MA 02111, USA. kenneth.getz@tufts.edu
authors.forename: Kenneth
authors.initials: K
authors.lastname: Getz
authors.forename: Zachary
authors.initials: Z
authors.lastname: Hallinan
authors.forename: Diane
authors.initials: D
authors.lastname: Simmons
authors.forename: Marla Jo
authors.initials: MJ
authors.lastname: Brickman
authors.forename: Zhanna
authors.initials: Z
authors.lastname: Jumadilova
authors.forename: Lynne
authors.initials: L
authors.lastname: Pauer
authors.forename: Marc
authors.initials: M
authors.lastname: Wilenzick
authors.forename: Briggs
authors.initials: B
authors.lastname: Morrison
mesh_terms: D001291:Attitude of Health Personnel; D002986:Clinical Trials as Topic / Q000523:psychology*; D003142:Communication; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D010358:Patient Participation / Q000523:psychology*; D012108:Research Personnel / Q000523:psychology*; D035842:Research Subjects / Q000523:psychology*; D013997:Time Factors