Fred Hutchinson Cancer Center, Seattle, WA.
University of Pennsylvania, Philadelphia, PA.
J Clin Oncol. 2024 Jun 20;42(18):2139-2148. doi: 10.1200/JCO.23.01030. Epub 2024 Apr 2.
National estimates of cancer clinical trial participation are nearly two decades old and have focused solely on enrollment to treatment trials, which does not reflect the willingness of patients to contribute to other elements of clinical research. We determined inclusive, contemporary estimates of clinical trial participation for adults with cancer using a national sample of data from the Commission on Cancer (CoC).
The data were obtained from accreditation information submitted by the 1,200 CoC programs, which represent more than 70% of all cancer cases diagnosed in the United States each year. Deidentified, institution-level aggregate counts of annual enrollment to treatment, biorepository, diagnostic, economic, genetic, prevention, quality-of-life (QOL), and registry studies were examined. Overall, study-type estimates for the period 2013-2017 were estimated. Multiple imputation by chained equations was used to account for missing data, with summary estimates calculated separately by type of program (eg, National Cancer Institute [NCI]-designated cancer centers) and pooled.
The overall estimated patient participation rate to cancer treatment trials was 7.1%. Patients with cancer participated in a wide variety of other studies, including biorepository (12.9%), registry (7.3%), genetic (3.6%), QOL (2.8%), diagnostic (2.5%), and economic (2.4%) studies. Treatment trial enrollment was 21.6% at NCI-designated comprehensive cancer centers, 5.4% at academic (non-NCI-designated) comprehensive cancer programs, 5.7% at integrated network cancer programs, and 4.1% at community programs. One in five patients (21.9%) participated in one or more cancer clinical research studies.
In a first-time use of national accreditation information from the CoC, enrollment to cancer treatment trials was 7.1%, higher than historical estimates of <5%. Patients participated in a diverse set of other study types. Contributions of adult patients with cancer to clinical research is more common than previously understood.
近二十年来，关于癌症临床试验参与率的全国性估计仅集中在治疗试验的入组方面，这并不能反映患者参与其他临床研究元素的意愿。我们使用来自癌症委员会（CoC）的全国性数据样本，确定了癌症成人患者参与临床试验的全面、现代的估计值。
这些数据来自 CoC 计划的认证信息，这些计划代表了美国每年诊断出的癌症病例的 70%以上。我们对每年治疗、生物库、诊断、经济、遗传、预防、生活质量（QOL）和登记研究的机构级总体入组计数进行了研究。总体而言，我们估计了 2013-2017 年期间的研究类型估计值。使用链方程的多重插补来处理缺失数据，按计划类型（例如，NCI 指定的癌症中心）分别计算并汇总总结估计值。
癌症治疗试验的总体估计患者参与率为 7.1%。癌症患者参与了各种其他研究，包括生物库（12.9%）、登记处（7.3%）、遗传学（3.6%）、QOL（2.8%）、诊断（2.5%）和经济学（2.4%）研究。NCI 指定的综合癌症中心的治疗试验入组率为 21.6%，学术（非 NCI 指定）综合癌症计划为 5.4%，综合网络癌症计划为 5.7%，社区计划为 4.1%。五分之一的患者（21.9%）参加了一项或多项癌症临床研究。
这是首次使用 CoC 的全国性认证信息，癌症治疗试验的入组率为 7.1%，高于之前<5%的估计值。患者参与了一系列不同的其他研究类型。癌症患者对临床研究的贡献比之前认为的更为常见。
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