Abstract B74: Behavioral and social science: Recruitment/retention/adherence research.

Abstract

Abstract Background: Enrollment in interventional therapeutic clinical trials is a small fraction of all patients who might participate given reasonable access. A case series of new prostate cancer cases are evaluated for their participation in a clinical trial. Methods: A hierarchical approach is utilized in measuring staged participation from trial availability to patient enrollment. Our framework suggests that concern for justice comes in the design and eligibility criteria for clinical trials; attention to beneficence is given in the eligibility and physician triage stages. The remaining four stages (doctor discussion with the patient, patient interest, patient consent, patient enrolled) rely on respect for persons. Reasons for nonparticipation or barriers to participation in prostate cancer clinical trials are examined within the seven step framework. Ninety-seven medical oncology patients with an initial six month consultation are tracked from one stage to the next to assess comparability of participation by race. Results: We illustrated seven transitions from being a patient to enrollment in a clinical trial in a case series of prostate cancer cases who consulted medical oncology in early 2010 (n=97). Pilot data suggest transition probabilities as follows for patients 65% had trial availability, of those 84% were eligible, of those 92% were triaged, of those 100% have trials discussion, of those 51% were interested, of those 71% consented, and of those 94% enrolled. The average transition probability was 77.7%. Trial availability, patient interest and patient consented were three transitions that were below average; none were statistically significant however. We combined steps to obtain the probability of a patient-trial-fit, 50%; the probability of opportunity, 51%; and the probability of acceptance, 66.7%. there were no differences in enrollments by race. Conclusions: The framework may serve to streamline comprehensive and improved reporting of clinical trial participation to the benefit of patients and toward the ethical conduct of clinical trials. The seven step framework may aid trouble shooting of flagging trial enrollment. Citation Format: Norma F. Kanarek, Marty Kanarek, Dare Olatoye, Michael Carducci. Behavioral and social science: Recruitment/retention/adherence research. [abstract]. In: Proceedings of the Fifth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2012 Oct 27-30; San Diego, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2012;21(10 Suppl):Abstract nr B74.