Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Alliance Statistics and Data Center, Mayo Clinic and Mayo Cancer Center, Rochester, Minnesota, USA.
Oncologist. 2018 Sep;23(9):1016-1023. doi: 10.1634/theoncologist.2018-0033. Epub 2018 Apr 19.
There are multiple known individual- and practice-level barriers to enrollment of older patients with cancer to clinical trials, but little is known about how the clinical research workforce feels about potential higher-level strategy changes aimed to promote increased enrollment of older patients.
SUBJECTS, MATERIALS, AND METHODS: We invited all 11,351 Alliance for Clinical Trials in Oncology ("Alliance") members to participate in an anonymous, web-based survey to examine awareness of current accrual patterns for older patients to clinical trials, to ascertain consensus on how to tackle enrollment challenges, and to provide the impetus for high-level changes to improve clinical trial accrual of older patients with cancer.
During the period from February 28, 2017, to June 16, 2017, 1,146 Alliance members participated (response rate = 10%), including a national diverse sample of physicians, nurses, administrative/clinical research staff, and patient advocates with representation from community, academic, and rural sites. Overall, one third felt that >50% of clinical trial enrollees should be age ≥65, and 64.9% felt the Alliance could improve upon enrollment of older patients. The four most commonly ranked strategies to improve enrollment of older patients were creating more dedicated trials for this population (36.3%), minimizing exclusion criteria focused on comorbidity (35.5%), developing independent strategies for those aged ≥65 and for those aged ≥70 (33.2%), and requiring that most/all Alliance trials have a specific expansion cohort of older patients (30.0%).
We anticipate that the recommendations from >1,000 Alliance members will continue to propel important strategy changes aimed to improve accrual of older patients with cancer to clinical trials.
This survey of the Alliance for Clinical Trials membership sought opinions on potential, large-scale, national strategies to improve accrual of older adults with cancer. Consensus was found around multiple strategies, including creating more dedicated trials for older patients, developing less stringent eligibility criteria, and mandating expansion cohorts of older patients within broader Alliance trials. It is anticipated that the recommendations from >1,000 Alliance members will continue to propel important strategy changes aimed to improve accrual of older patients with cancer to clinical trials.
存在多种已知的个体和实践层面的障碍，导致癌症老年患者参与临床试验，但对于旨在促进更多老年患者参与的潜在高级策略变化，临床研究人员对此有何看法，目前知之甚少。
我们邀请了所有 11351 名肿瘤临床研究联盟（Alliance）成员参与一项匿名的网络调查，以了解他们对当前老年患者参与临床试验的入组模式的认识，确定解决入组挑战的共识，并为提高癌症老年患者临床试验入组率提供高级别改变的动力。
在 2017 年 2 月 28 日至 2017 年 6 月 16 日期间，有 1146 名 Alliance 成员参与了调查（回应率为 10%），包括来自社区、学术和农村地区的医生、护士、行政/临床研究人员和患者权益倡导者，代表了全国不同的人群。总体而言，三分之一的人认为应该有 >50%的临床试验入组者年龄≥65 岁，64.9%的人认为 Alliance 可以改善老年患者的入组情况。改善老年患者入组的四项最常被列为策略是为这一人群设立更多专门的试验（36.3%）、最小化针对合并症的排除标准（35.5%）、为≥65 岁和≥70 岁的患者制定独立的策略（33.2%）以及要求大多数/所有 Alliance 试验都有特定的老年患者扩展队列（30.0%）。
我们预计，超过 1000 名 Alliance 成员的建议将继续推动旨在改善癌症老年患者临床试验入组率的重要策略变化。
这项针对肿瘤临床研究联盟成员的调查旨在征求关于改善癌症老年患者入组的潜在、大规模、全国性策略的意见。研究人员在多个策略上达成了共识，包括为老年患者设立更多专门的试验、制定更宽松的入组标准，以及在更广泛的联盟试验中规定老年患者的扩展队列。我们预计，超过 1000 名 Alliance 成员的建议将继续推动旨在改善癌症老年患者临床试验入组率的重要策略变化。
