肿瘤临床药师干预对美国肿瘤网络 MYLUNG 联盟临床试验注册的影响

Elizabeth Koselke, PharmD, BCOP, Lisa C. Kaspin-Powell, PhD, Shannon Hough, PharmD, BCOP, Joshua Howell, PharmD, BCOP, Nicholas J. Robert, MD, Marcus A. Neubauer, MD, Susie A. Bullock, DNP, MPH, RN, OCN®, CCRP, Jennifer M. Walberg, MPH, Melissa Rammage, PharmD, MS, BCOP, James E. Butrynksi, MD, David Hakimian, MD, Robert M. Jotte, MD, PhD, Michael W. Meshad, MD, Kashif Ali, MD, David Michael Waterhouse, MD, MPH, Robert L. Coleman, MD, FACOG, FACS, Makenzi Colleen Evangelist, MD
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摘要

导言:社区癌症网络中的肺癌分子信息治疗:A Pragmatic Consortium™ (MYLUNG) 临床试验平台旨在通过一系列前瞻性迭代临床试验,推动精准医疗在非小细胞肺癌患者中的应用。及时将患者纳入肿瘤临床试验是一项众所周知的实践挑战,不良的纳入率会导致试验过早结束或试验结果不理想。美国肿瘤网络最近实施了一项临床药剂师(ClinReview)计划,提供远程临床服务,筛选患者加入 MYLUNG 协议 2。本研究旨在评估远程临床药剂师干预对研究注册率的影响。研究方法一名接受过肿瘤学培训的临床药剂师在正常工作流程中远程查看了全身化疗治疗单,此外还查看了六个社区网络诊所(149 名医生)的每周定制招募报告。药剂师确定、筛选并协助沟通符合招募条件的患者。现场研究团队及时收到相关患者数据,以加快入组速度。对注册和干预数据进行跟踪,以监测药剂师干预的效果。采用配对 t 检验对每月的注册情况进行评估。结果在 8 个月的时间里,药剂师筛选了 506 名可能符合条件的患者,其中 34% 的患者加入了该计划。在 ClinReview 干预后,平均每月注册人数明显增加(3.4 人/月 vs. 6.6 人/月;p = .02)。在未加入的 289 名患者中,73% 的患者超过了资格窗口期,9% 的患者死亡或加入临终关怀,4% 的患者拒绝加入,13% 的患者转院或在外部机构接受治疗。结论将肿瘤临床药师纳入临床研究团队与提高临床试验注册率有关。我们将在未来的 "MYLUNG "迭代中验证多学科干预措施对更广泛的资源不同的肿瘤临床实践的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Impact of an Oncology Clinical Pharmacist Intervention on Clinical Trial Enrollment in The US Oncology Network’s MYLUNG Consortium
Introduction: 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. Methods: 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 t-test. Results: 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; p = .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. Conclusions: 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.
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