Diversity of participants in clinical trials in an academic medical center

Abstract

BACKGROUND: Only 2.5% of adults and even fewer minorities participate in cancer therapeutic trials. Researchers have concluded that many barriers to participation stem from how recruitment is performed by clinician investigators. The objective of the current research was to document specifically how these barriers impede recruitment in the clinical setting. METHODS: The authors conducted a case study of recruitment in an academic medical center using ethnographic research methods (direct observation of provider-patient interactions and in-depth interviews with providers) to collect data. Qualitative data analysis was used to identify themes related to the provider's role in the recruitment processes. RESULTS: In the clinics that were studied, the authors observed that providers subjectively assessed which patients seemed to be ‘good study patients’ to target for recruitment. ‘Good study patients’ were identified as those who were able to adhere to complex trial protocols, thus helping clinician researchers to complete studies in a timely and efficient manner. These patients were perceived as meticulous, proactive, and compliant; they were considered good communicators; and they were embedded in the kinds of strong social support networks that facilitated their trials participation. CONCLUSIONS: The providers that were studied sought ‘good study patients’ for therapeutic trials because they wanted to perform studies in a timely and efficient manner. Future research should examine whether providers in other settings also target their recruitment efforts for this or other reasons. Further research also should consider whether differentially recruiting ‘good patients’ can impact the ethnic/racial diversity or other characteristics of trial participants in ways that may bias the outcomes or conclusions of therapeutic trials. Cancer 2009. © 2009 American Cancer Society.