Examining Enrollment Barriers to Adult Cancer Clinical Trials

Abstract

Advancing knowledge in cancer treatment can only be achieved with the conduct of clinical trials. Barriers to adult cancer clinical trial participation have been extensively examined, yet nearly 20% of trials fail due to low patient enrollment. This dissertation considers the gaps in knowledge related to health policy, healthcare industry changes, and variation in oncology service provider behavior in the conduct of cancer clinical trials. In the first study, we used data collected from an internet-based survey of cancer clinical trial sites across the nation and found that sites continued to receive insurance coverage denials for patients seeking treatment through participation in a cancer clinical trial after the 2010 Affordable Care Act’s mandate requiring most private health insurers to cover routine patient care costs for trial participation. Organizational characteristics of being National Cancer Institute designated and having previous state legislation related to coverage for clinical trial participation were not associated with receiving denials, while being an academic medical center and using a precertification process were significantly associated with receiving insurance denials. These results suggest that insurance denials and delays continue to be formidable barriers to the research community in achieving adequate and timely trial enrollment, thus negatively affecting the pace of cancer discovery. The second study used previously collected qualitative data and a validated theoretical framework to understand the substantial decrease in clinical trial enrollment related to changes in community cancer site personnel behavior after being acquired by a large, tertiary health system. These staff perceived many barriers to enrollment being present after the acquisition, particularly related to the opportunity and their capability to conduct clinical trials. The lack of support to conduct clinical trials by having adequate staff and available trials within which to enroll were perceived to be the primary barriers. Use of a theoretical model to understand changes in behavior adds to the empirically-based clinical trial enrollment barrier literature, and may be more helpful in matching future interventions to behavior determinants to address remaining barriers. There is demonstrated variation in providers following treatment guidelines. The final study was a retrospective analysis of data from a large health system’s electronic health record and clinical trial management systems to assess radiation oncologist variation in the completion of a field for recording patient assessment for trial participation. Completion of this field may serve as a proxy for radiation oncologist awareness of available clinical trials. We found radiation oncologist characteristics are not significantly correlated with recording patient assessment for clinical trial participation. This field was completed just over 40% of the time, identifying the need for additional evaluation of the factors motivating radiation oncologists to complete this field. Overall, there are organization and provider factors that negatively affect cancer research centers efforts to identify and enroll adult cancer patients into clinical trials.