Health Access and Action Consulting, Newton, Massachusetts, USA.
The Leukemia & Lymphoma Society, New York, New York, USA.
Cancer Med. 2024 May;13(10):e7298. doi: 10.1002/cam4.7298.
Despite the importance of clinical trial participation among cancer patients, few participate-and even fewer patients from ethnic and racial minoritized groups. It is unclear whether suggested approaches to increase accrual are successful. We conducted a scoping review to identify evidence-based approaches to increase participation in cancer treatment clinical trials that demonstrated clear increases in accrual. Notably, more stringent than other published reviews, only those studies with comparison data to measure a difference in accrual rates were included.
We searched PubMed/MEDLINE, Embase, CINAHL, and Web of Science for English-language articles published from January 1, 2012, to August 8, 2022. Studies were included if they were conducted in the United States, described single or multicomponent interventions, and provided data to measure accrual relative to baseline levels or that compared accrual rates with other interventions.
Sixteen articles were included: six with interventions addressing patient barriers, two addressing provider barriers, seven describing institutional change, and one describing policy change. Key themes emerged, such as a focus on patient education, cultural competency, and building the capacity of clinics. Few studies provide comparative accrual data, making it difficult to identify with certainty any effective, evidence-based approaches for increasing accrual. Some patient- and system-level interventions studies showed modest increases in accrual primarily through pre-post measurement.
Despite an extensive body of literature about the barriers that impede cancer treatment trial accrual, along with numerous recommendations for how to overcome these barriers, results reveal surprisingly little evidence published in the last 10 years on interventions that increase accrual relative to baseline levels or compared with other interventions. As clinical trials are a primary vehicle through which we improve cancer care, it is critical that evidence-based approaches are used to inform all efforts to increase accrual. Strategies for increasing participation in cancer clinical trials must be developed and rigorously evaluated so that these strategies can be disseminated, participation in trials can increase and become more equitable, and trial results can become more generalizable.
尽管癌症患者参与临床试验非常重要，但参与的患者很少，来自少数民族群体的患者就更少了。目前尚不清楚增加参与率的建议方法是否有效。我们进行了范围界定审查，以确定增加癌症治疗临床试验参与率的循证方法，这些方法被证明能明显增加参与率。值得注意的是，与其他已发表的综述相比，该综述的标准更为严格，仅纳入了那些有比较数据以衡量参与率差异的研究。
我们在 PubMed/MEDLINE、Embase、CINAHL 和 Web of Science 中检索了 2012 年 1 月 1 日至 2022 年 8 月 8 日发表的英文文章。如果研究在美国进行、描述了单一或多组分干预措施，并提供了数据来衡量相对于基线水平的参与率，或比较了与其他干预措施的参与率，则将其纳入研究。
共纳入 16 篇文章：6 篇干预措施针对患者障碍，2 篇干预措施针对提供者障碍，7 篇描述了机构变革，1 篇描述了政策变革。出现了一些关键主题，例如注重患者教育、文化能力和提高诊所能力。很少有研究提供比较性的参与数据，因此很难确定哪些方法有效、有循证依据可用于增加参与率。一些患者和系统水平的干预研究主要通过前后测量显示出适度的参与率增加。
尽管有大量文献探讨了阻碍癌症治疗试验参与率的障碍，以及许多克服这些障碍的建议，但令人惊讶的是，在过去 10 年中，关于增加相对于基线水平或与其他干预措施相比的参与率的干预措施，发表的证据却很少。由于临床试验是改善癌症治疗的主要手段，因此必须使用循证方法来为所有增加参与率的努力提供信息。必须制定并严格评估增加癌症临床试验参与率的策略，以便能够传播这些策略，增加参与率并使其更加公平，以及使试验结果更具普遍性。
