Koselke Elizabeth, Kaspin-Powell Lisa C, Hough Shannon, Howell Joshua, Robert Nicholas J, Neubauer Marcus A, Bullock Susie A, Walberg Jennifer M, Rammage Melissa, Butrynski James E, Hakimian David, Jotte Robert M, Meshad Michael W, Ali Kashif, Waterhouse David Michael, Coleman Robert L, Evangelist Makenzi Colleen
From US Oncology Network, McKesson Specialty Health, The Woodlands, Texas.
Ontada, Boston, Massachusetts.
J Adv Pract Oncol. 2024 Jul 21:1-10. doi: 10.6004/jadpro.2024.15.8.7.
The Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium™ (MYLUNG) clinical trial platform aims to advance the use of precision medicine in patients with non-small cell lung cancer through a series of prospective and iterative clinical trials. Timely patient accrual onto oncology clinical trials is a known practice challenge and impaired accrual rates can lead to premature trial closure or properly powered trial outcomes. The US Oncology Network recently implemented a clinical pharmacist (ClinReview) initiative to provide remote clinical services to screen patients for enrollment onto MYLUNG Protocol 2. This study aims to evaluate the effect of the remote clinical pharmacist intervention on study enrollment rates.
An oncology-trained clinical pharmacist remotely reviewed systemic chemotherapy treatment orders during normal workflow and, in addition, a weekly custom recruitment report within six community Network practices (149 physicians). The pharmacist identified, screened, and assisted with the communication regarding eligible patients for enrollment. The onsite research team received timely and relevant patient data to facilitate expedited enrollment. Enrollment and intervention data were tracked to monitor the impact of the pharmacist intervention. Monthly enrollment was evaluated using a paired -test.
Over 8 months, the pharmacist screened 506 potentially eligible patients; 34% were enrolled. Average monthly enrollment was significantly greater following the ClinReview intervention (3.4 vs. 6.6 patients/month; = .02). Among the 289 patients not enrolled, 73% exceeded their eligibility window, 9% died or enrolled into hospice, 4% declined participation, and 13% transferred care or were treated at outside facilities.
Incorporating an oncology clinical pharmacist into the clinical research team was associated with improved clinical trial enrollment. Validation of the effect of multidisciplinary interventions across a broader spectrum of differentially resourced oncology practices will be conducted within future MYLUNG iterations.
社区癌症网络中基于分子信息的肺癌治疗：实用联盟™（MYLUNG）临床试验平台旨在通过一系列前瞻性和迭代性临床试验，推动精准医学在非小细胞肺癌患者中的应用。及时让患者加入肿瘤学临床试验是一个已知的实践挑战，而招募率受损可能导致试验提前结束或无法得出有充分统计学效力的试验结果。美国肿瘤学网络最近实施了一项临床药剂师（临床审查）计划，以提供远程临床服务，筛选患者加入MYLUNG方案2。本研究旨在评估远程临床药剂师干预对研究招募率的影响。
一名经过肿瘤学培训的临床药剂师在正常工作流程中远程审查全身化疗治疗医嘱，此外，还审查六个社区网络机构（149名医生）内每周的定制招募报告。药剂师识别、筛选并协助就符合条件的患者招募事宜进行沟通。现场研究团队收到及时且相关的患者数据，以促进加快招募。跟踪招募和干预数据，以监测药剂师干预的影响。使用配对t检验评估每月招募情况。
在8个月的时间里，药剂师筛选了506名潜在符合条件的患者；34%的患者被招募。临床审查干预后，平均每月招募人数显著增加（3.4名患者/月对6.6名患者/月；P = 0.02）。在289名未被招募的患者中，73%超过了他们的符合条件期限，9%死亡或进入临终关怀，4%拒绝参与，13%转诊或在外部机构接受治疗。
将肿瘤学临床药剂师纳入临床研究团队与改善临床试验招募情况相关。未来的MYLUNG迭代中将在更广泛的不同资源水平的肿瘤学实践中对多学科干预的效果进行验证。
