ABSTRACT
Background: Access to health care including clinical trials (CT) leading to paradigm-changing cancer treatments are critical for high quality cancer care and equity in society. In this report, we highlight methods in accruing to ETCTN wherein underrepresented rural, low-income, and racial minorities comprise >50% of enrollment. Methods: University of Kansas Cancer Center (KUCC) is one of eight National Cancer Institute (NCI) designated cancer centers awarded CATCH-UP.2020 (CATCH-UP), a congressionally mandated P30 supplement to enhance access for minority/underserved populations to ETCTN precision medicine CT. KUCC catchment area is 23% rural by Rural Urban Continuum Codes (RUCC);almost 90 % of counties are designated primary care HPSA's (Health Professional Shortage Areas). KUCC Early Phase and Masonic Cancer Alliance (rural outreach network) partnered to operationalize CATCH-UP. We engaged disease-focused champion investigators in disease working groups and MCA physicians who selected scientifically sound CT that fit catchment area needs. Patient and Investigator Voices Organizing Together, a patient research advocacy group provided practical feedback. MCA navigator coordinated recruitment. Telehealth was used for rural patients that would have a significant distance to travel just to be screened. Results: CATCH-UP was initiated in September 2020. Twenty-eight CT were activated, many in community sites. Average activation time was 81 days. Delays were mainly from CT amendments. KUCC enrolled the first patient in the CATCH-UP program. In 6 months, we met accrual requirements (24/year, 50% minorities). During first year, we enrolled 47 (>50% minorities), an increase of 680% from our average accrual of 6/year (>50% minorities) in ETCTN through Early Drug Development Opportunity Program (2016-2020). To date, we have enrolled 61, 54% from rural, HPSA, race and other minorities. Although the proportion of minorities did not change but remained high, this funding allowed us to substantially increase the number of patients from a catchment area with high proportion of geographically and socioeconomically underserved minorities given access to early phase CT through ETCTN. Conclusions: Amid COVID-19 pandemic, the NCI CATCH-UP program and methods we used allowed access to novel therapies for rural, medically underserved, and other minority groups.
ABSTRACT
Background: The National Cancer Institute supports several national trial networks which responded rapidly to the COVID-19 pandemic to overcome operational barriers to clinical cancer research. The National Clinical Trials Network (NCTN) focuses on late phase treatment trials, while the Experimental Therapeutics Clinical Trials Network (ETCTN) conducts early phase treatment trials. We report findings on the experience and adaptations of these networks during COVID-19. Methods: Using 2019 and 2020 accrual data, we analyzed changes in accrual levels and demographics. We also evaluated changes in trial activation numbers and timelines. In July 2020, we surveyed 255 investigators from academic and community sites to assess changes in research practices and get feedback on modified processes implemented by NCI to address trial conduct during the pandemic. Results: Accrual across the NCTN and ETCTN fell significantly in midMarch 2020, dropping from a weekly average of 307 patients in February to 169 the week of March 23-29. Accrual began to recover in June and July but did not return to pre-pandemic levels until September. Accrual in November and December 2020 followed the patterns seen in 2019, with short-term drops around major holidays. Non-White participants were enrolled to NCTN and ETCTN trials at similar monthly rates throughout 2019 and 2020, with slightly higher overall enrollment in 2020 (23.7% vs. 22.7%). New trials continued to be developed and activated throughout 2020. Between 2017 and 2019, an average of 71 trials were activated per year (NCTN = 46, ETCTN = 25), compared to 84 activated in 2020 (NCTN = 58, ETCTN = 26). The average time to trial activation was similar or slightly longer in 2020 compared to 2019. The investigator survey yielded 111 responses (43.5% response rate). 43% of respondents' sites paused enrollment to phase 1 trials during the pandemic, compared to 18% for phase 3 trials. Many sites temporarily stopped opening new trials and processing specimens. Sites were more likely to keep enrolling to trials offering clear potential benefit and pause complex trials that required more patient contact. Respondents attributed some of the decline in accrual to a reduction in overall patient volume, increased patient concerns, and reduced research staff on site. Respondents were asked to rate the usefulness of modified trial processes NCI put in place during the pandemic. Telehealth was rated most useful (avg. 4.6/5), followed by shipping oral IND agents to enrolled patients (4.5/5), remote informed consent (4.2/5), coordinating care with local providers (3.9/5), and remote auditing (3.7/5). Conclusions: The cancer trials community has an opportunity to learn from working through the challenges of COVID-19. NCI will seek to continue and expand on modifications to clinical trial processes that have the potential to improve operational efficiency, reduce cost, and help bring trials to more patients.