Enhancing Enrollment of Patients to Radiation Oncology Clinical Trials Across a Multi-Institutional Community-Academic Partnership: An Interrupted Time Series Analysis

Abstract

<h3>Purpose/Objective(s)</h3> Although clinical trial enrollment is critical to development of new cancer therapies, < 5% of cancer patients in the United States enroll onto trials. Participation is particularly low among underrepresented minority groups, who comprise < 20% of enrollments. Community-academic partnerships have the potential to improve patient access to clinical trials, as most patients are treated for cancer in the community. In 2017, our tertiary cancer center began opening investigator-initiated clinical trials in radiation oncology in our community partner sites. This study evaluates demographics of patients enrolled, the effectiveness of strategies to address potential barriers to enrollment, and variation among physician enrollers. <h3>Materials/Methods</h3> All patients enrolled on radiation oncology therapeutic clinical trials at community-based partner sites from Q2 2018 – Q1 2021 were included in this analysis. Guided by Expert Recommendation for Implementing Change (ERIC), strategies to increase trial enrollment were implemented prior to Q2 2020, and included: 1) altered incentive structure (per-patient cost paid to partner site, leaderboards), 2) building a coalition of physicians in metastatic disease, and 3) practice facilitation. An interrupted time series analysis included a two-tailed student's t-test to compare mean trial enrollments per quarter pre- and post-implementation. Protocol deviations were assessed in quality assurance (QA) review. <h3>Results</h3> Among 52 total patients enrolled in community-based, partner sites, 28 (54%) identify as Black or Hispanic. The number of clinical trials open to enrollment pre- and post-implementation was 5 vs. 8, respectively, while the number of patients enrolled was 6 vs. 46, respectively, representing an overall increase in mean number of quarterly patient enrollments from 1 to 11 (<i>P</i> < 0.02). The patient enrollment trend (slope) also increased from -0.1 to 6.5 pre- and post-implementation. In the post-implementation period, the greatest number of enrollments occurred among patients treated for metastatic disease (n = 28). Among 49 radiation oncologists, 7 (14%) enrolled at least one patient, and total enrollments per physician ranged from 0-24. QA review revealed that patient-reported outcomes (PROs) were available only in English, resulting in missing data for secondary endpoints in 3 patients with Spanish as their preferred language. <h3>Conclusion</h3> These implementation strategies were associated with increased therapeutic trial enrollment in community-based partner sites. With high variation in enrollment between physicians and prior research suggesting limited impact of site-level financial incentives, qualitative research will further investigate non-financial incentives and other facilitators to clinical trial enrollment within community-academic partnerships. Over-representation of minority patients further supports the benefit of enrolling patients on clinical trials in the community-based setting.