Department of Medicine, Division of Hematology/Oncology, University of California San Francisco, San Francisco, CA, USA; Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.
Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA; Institute for Health & Aging, Department of Social and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA.
J Cancer Policy. 2021 Dec;30:100305. doi: 10.1016/j.jcpo.2021.100305. Epub 2021 Sep 4.
Cancer treatment clinical trials face major challenges with patient recruitment. Strategies to address patient indirect costs associated with clinical trial participation may accelerate accrual overall. The current study examined the effect of the IMproving Patient Access to Clinical Trials (IMPACT) intervention on patient accrual to cancer treatment clinical trials at an academic medical center. The IMPACT intervention was an onsite patient navigator combined with a financial reimbursement program to address patient out of pocket costs and began on September 2018.
This analysis measured frequency of patient enrollment in cancer treatment clinical trials and available cancer treatment clinical trials per month between January 1, 2016 and March 31, 2020. An interrupted time-series analysis (ITSA) was conducted to estimate changes in patient enrollment attributable to the IMPACT intervention.
During the study period, a mean of 69 patients enrolled in clinical trials per month (standard deviation (SD = 13), with 27 (SD = 7) in early phase vs 41 (SD = 12) in late phase clinical trials. The number of available clinical trials per month was 51 (SD = 2) overall, with 23 (SD = 1) in early phase vs 28 (SD = 1) in late phase context. A total of 3470 patients were enrolled in cancer treatment clinical trials during the evaluated time period, the majority of whom were men (1895, 55 %) and racially white (2267, 65 %). A statistically significant increase in the number of patients accrued as compared to the pre-intervention trend was observed; with approximately 1 additional patient accrued per month, with a larger effect on increase patient accrual for late phase clinical trials.
This study observed that the IMPACT intervention accelerated clinical trial recruitment, especially among late phase clinical trials. Future research will examine strategies to leverage this infrastructure to optimize recruitment among underrepresented patients.
To improve clinical trial recruitment and ensure that trial results are representative of a diverse population it is critical for health policies consider patient out-of-pocket costs and potential reimbursement to alleviate financial burden associated with clinical trial participation. Furthermore, policies for facilitating clinical trial recruitment and participant retention should budget for and incorporate a navigation component to assist patients who may not be familiar with the healthcare system and available financial assistance.
癌症治疗临床试验在患者招募方面面临重大挑战。解决与临床试验参与相关的患者间接成本的策略可能会全面加速入组速度。本研究旨在检验在学术医疗中心，通过“改善临床试验患者准入（IMPACT）”项目干预对癌症治疗临床试验患者入组的影响。IMPACT 干预措施是一个现场患者导航员和财务报销计划的结合，旨在解决患者的自费支出，并于 2018 年 9 月开始实施。
本分析测量了 2016 年 1 月 1 日至 2020 年 3 月 31 日期间，癌症治疗临床试验的患者入组频率和每月可用的癌症治疗临床试验数量。采用中断时间序列分析（ITSA）来估计 IMPACT 干预对患者入组的影响。
在研究期间，平均每月有 69 名患者入组临床试验（标准差（SD）=13），其中 27 名（SD=7）处于早期阶段，41 名（SD=12）处于晚期阶段。每月可用的临床试验数量为 51 个（SD=2），其中 23 个（SD=1）处于早期阶段，28 个（SD=1）处于晚期阶段。在评估期间，共有 3470 名患者入组癌症治疗临床试验，其中大多数为男性（1895 名，55%）和白种人（2267 名，65%）。与干预前的趋势相比，入组患者数量有显著增加；每月增加约 1 名患者，晚期临床试验的患者入组增加幅度更大。
本研究观察到，IMPACT 干预措施加速了临床试验的招募，尤其是晚期临床试验。未来的研究将探讨利用这种基础设施来优化代表性不足的患者招募的策略。
为了改善临床试验的招募并确保试验结果代表多样化的人群，卫生政策必须考虑患者的自费支出和潜在报销，以减轻参与临床试验的经济负担。此外，促进临床试验招募和参与者保留的政策应预算并纳入导航部分，以帮助可能不熟悉医疗保健系统和可用财务援助的患者。
