增加社区学术合作临床试验参与率的实施策略及其对西班牙裔代表性的影响：一项中断时间序列分析。
Implementation Strategies to Increase Clinical Trial Enrollment in a Community-Academic Partnership and Impact on Hispanic Representation: An Interrupted Time Series Analysis.
机构信息
Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.
Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, FL.
出版信息
JCO Oncol Pract. 2022 May;18(5):e780-e785. doi: 10.1200/OP.22.00037.
PURPOSE
Community-academic partnerships have the potential to improve access to clinical trials for under-represented minority patients who more often receive cancer treatment in community settings. In 2017, the Memorial Sloan Kettering (MSK) Cancer Center began opening investigator-initiated clinical trials in radiation oncology in targeted community-based partner sites with a high potential to improve diverse population accrual. This study evaluates the effectiveness of a set of implementation strategies for increasing overall community-based enrollment and the resulting proportional enrollment of Hispanic patients on trials on the basis of availability in community-based partner sites.
METHODS
An interrupted time series analysis evaluating implementation strategies was conducted from April 2018 to September 2021. Descriptive analysis ofHispanic enrollment on investigator-initiated randomized therapeutic radiation trials open at community-based sites was compared with those open only at themain academic center.
RESULTS
Overall, 84 patients were enrolled in clinical trials in the MSK Alliance, of which 48 (56%) identified as Hispanic. The quarterly patient enrollment pre- vs postimplementation increased from 1.39 (95% CI, -3.67 to 6.46) to 9.42 (95% CI, 2.05 to 16.78; P5 .017). In the investigator-initiated randomized therapeutic radiation trials open in the MSK Alliance, Hispanic representation was 11.5% and 35.9% in twometastatic trials and 14.2% in a proton versus photon trial. Inmatched trials open only at the main academic center, Hispanic representation was 5.6%, 6.0%, and 4.0%, respectively.
CONCLUSION
A combination of practice-level and physician-level strategies implemented at community-based partner sites was associated with increased clinical trial enrollment, which translated to improved Hispanic representation. This supports the role Q:2 of strategic community-academic partnerships in addressing disparities in clinical trial enrollment.
目的
学术-社区伙伴关系有可能改善代表性不足的少数族裔患者的临床试验机会，这些患者更常在社区环境中接受癌症治疗。2017 年，纪念斯隆凯特琳癌症中心（MSK）开始在目标社区合作伙伴站点开放研究人员发起的放射肿瘤学临床试验，这些站点具有提高多样化人群入组的高潜力。本研究评估了一组实施策略的有效性，这些策略旨在增加整体社区基础入组，并根据社区合作伙伴站点的可用性，使西班牙裔患者在试验中的比例入组。
方法
从 2018 年 4 月至 2021 年 9 月，进行了一项评估实施策略的中断时间序列分析。对在社区基地站点开放的研究人员发起的随机治疗性放射试验中西班牙裔入组情况进行描述性分析，并与仅在主要学术中心开放的试验进行比较。
结果
总体而言，在 MSK 联盟中有 84 名患者参加了临床试验，其中 48 名（56%）为西班牙裔。实施前与实施后每季度的患者入组人数从 1.39（95%CI，-3.67 至 6.46）增加到 9.42（95%CI，2.05 至 16.78；P5.017）。在 MSK 联盟中开放的研究人员发起的随机治疗性放射试验中，西班牙裔的代表性在两项转移性试验中分别为 11.5%和 35.9%，在质子与光子试验中为 14.2%。在仅在主要学术中心开放的匹配试验中，西班牙裔的代表性分别为 5.6%、6.0%和 4.0%。
结论
在社区合作伙伴站点实施的实践层面和医生层面的策略组合与临床试验入组的增加有关，这转化为西班牙裔代表性的提高。这支持了战略性学术-社区伙伴关系在解决临床试验入组差异方面的作用。
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