Consent Timing and Experience: Modifiable Factors That May Influence Interest in Clinical Research
- David E. Gerber, MD⇓,
- Drew W. Rasco, MD,
- Celette Sugg Skinner, PhD,
- Jonathan E. Dowell, MD,
- Jingsheng Yan, PhD,
- Jennifer R. Sayne, MS and
- Yang Xie, MD, PhD
+ Author Affiliations
- Corresponding author: David E. Gerber, MD, Department of Internal Medicine (Division of Hematology-Oncology), Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Mail Code 8852, Dallas, TX 75390-8852; e-mail: firstname.lastname@example.org.
Purpose: Low rates of participation in cancer clinical trials have been attributed to patient, institutional, and study characteristics. However, few studies have examined factors related to the consent process. We therefore evaluated the impact of consent timing and experience on markers of patient interest in research.
Methods: We performed a retrospective analysis of patients enrolled in a cancer center tissue repository. During enrollment, patients were asked if they were willing to be contacted in the future to provide medical follow-up information and/or to participate in other clinical research. We analyzed the association between patient responses to these questions and consent process factors using univariate analysis and multivariate logistic regression.
Results: Of 922 patients evaluated, 85% agreed to be contacted to provide follow-up information, and 83% agreed to be contacted to participate in future research studies. In univariate analysis, willingness to be contacted for future research was associated with consenter experience (P = .01) and had a trend toward association with the timing of enrollment in relation to diagnosis (P = .08), but it was not associated with patient sex, race, or diagnosis. In multivariate analysis, responses remained associated with consenter experience (P = .02).
Conclusion: Factors related to the consent process, including consenter experience and timing of study enrollment, are significantly associated with or have a trend toward association with markers of patient interest in clinical research. These understudied and potentially modifiable variables warrant further evaluation.
- Accepted June 6, 2011.