Overcoming Challenges Posed by Biomarker-Selective Clinical Trials: The Role of a Research Specialist

项目总结/摘要 分子检测和靶向治疗彻底改变了癌症护理， 患者生物标志物选择性临床试验的数量继续增加，这给生物标志物的临床应用带来了挑战。 癌症中心，以适应这些临床试验的患者的有效识别和登记的过程。 此外，在少数民族和少数族裔的分子检测和临床试验招募方面存在差距， 服务不足的人群。应对这些挑战在确保公平和 为所有患者提供有效的护理。约翰·霍普金斯西德尼·金梅尔综合癌症中心是一家NCI- 指定的综合癌症中心和八个领导角色之一，在NCI实验 治疗药物临床试验网络（ETCTN）和NCI国家临床试验网络（NCTN）。生物标志物- 选择性研究是这两个网络的主要重点。在这个R50项目中，盖拉尔博士将重点关注 解决了生物标志物选择性试验患者招募的挑战。工作将集中在三个方面 方法：㈠建立分子登记册，以改进患者身份识别过程， 在中心层面确定患者的合格性，（ii）促进及时转诊至生物标志物选择性试验 使用电子病历临床试验警报，为合格的患者在医生的水平，和（iii）提供 及时接受生物标志物在治疗决策中的作用教育的符合研究条件的患者（患者 水平）。该计划的长期目标是开发一个精简的管道，用于识别，参考和 招募患者进行个性化药物试验。成功的开发将提高NCI的应计费用- 赞助的临床试验，并可转移到其他癌症中心。

Project Summary/Abstract Molecular testing and targeted therapies have revolutionized cancer care resulting in better outcomes for patients. The number of biomarker-selective clinical trials continues to increase presenting challenges for cancer centers to adapt processes for efficient identification and enrollment of patients to these clinical trials. Furthermore, there is a gap in uptake of molecular testing and clinical trial enrollment for minority and underserved populations. Addressing these challenges plays an important role in ensuring equitable and effective care for all patients. The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center is an NCI- designated Comprehensive Cancer Center and one of eight with lead roles in both the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) and NCI National Clinical Trials Network (NCTN). Biomarker- selective studies are a major focus of these two networks. In this R50 Project, Dr. Gaillard will focus on addressing challenges in patient enrollment to biomarker-selective trials. The work will focus on three approaches: (i) development of a molecular registry to improve process of patient identification and determination of patient eligibility at the Center level, (ii) facilitate timely referrals to biomarker-selective trials using an electronic medical record clinical trials alert for eligible patients at the Physician level, and (iii) provide study-eligible patients with timely education on the role of biomarkers in treatment decision making (Patient level). The long term goal of this program is to develop a streamlined conduit for identifying, referring and enrolling patients for personalized medicine trials. Successful development will enhance accrual to NCI- sponsored clinical trials and be translatable to other cancer centers.