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The Impact of Consenter Characteristics and Experience on Patient Interest in Clinical Research

^aDepartment of Internal Medicine (Hematology-Oncology), ^bDepartment of Clinical Sciences, and ^cDepartment of Pathology, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA

Key Words. Consenters • Clinical trials • Cancer • Recruitment • Accrual

Correspondence: Correspondence: David E. Gerber, M.D., Division of Hematology-Oncology, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, MC 8852, Dallas, Texas 75390-8852, USA. Telephone: 214-648-4180; Fax: 214-648-1955; e-mail: david.gerber{at}utsouthwestern.edu

Received December 9, 2008; accepted for publication March 19, 2009.

Disclosures: Drew W. Rasco: None; Yang Xie: None; Jingsheng Yan: None; Jennifer R. Sayne: None; Celette Sugg Skinner: None; Jonathan E. Dowell: Research funding/contracted research: Genentech, Inc. David E. Gerber: Research funding/contracted research: Genentech, Inc., ImClone Systems, Gloucester Pharmaceuticals. Section editors <disclosures to come>. The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias.

Background. To explain the historically low rates of participation in cancer clinical trials, several factors have been studied. These include subject characteristics and attitudes, clinical trial availability and eligibility criteria, and physician attitudes and communication skills. However, the impact of nonphysician research personnel, who often consent patients for studies, is unclear. We therefore evaluated the association between consenter characteristics and subject interest in clinical research.

Methods. We performed a retrospective review of subjects enrolled in a university-based cancer center tissue repository. During enrollment, subjects were asked if they were willing to be contacted in the future to (a) provide medical follow-up information and (b) participate in other clinical research. We analyzed the association between responses to these questions and consenter characteristics using univariate analysis and multivariate logistic regression.

Results. In total, 181 consenters enrolled 922 subjects. The majority of subjects agreed to be contacted for follow-up (84.9%) and future research (83.1%). Subject willingness to be contacted for future research was associated with greater consenter experience in univariate and multivariate analyses. In multivariate analysis, subject willingness to be contacted for future research was associated with discordance between subject and consenter gender, but not with subject gender, race, or income, or consenter gender or race.

Conclusions. Consenter experience and subject–consenter gender discordance were associated with greater subject interest in participating in future research. The role of consenters in clinical research merits future study and should be considered in efforts to increase cancer clinical trial accrual.

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