Overcoming Barriers to Early Phase Clinical Trials

描述（由申请人提供） 该应用程序解决了少数群体早期（I期-II期）癌症临床试验的低累积率。我们已经确定少数民族患者转诊到医院的比例较低，这些医院包括Dana-Farber/哈佛癌症中心、贝斯以色列女执事医院、布里格姆妇女医院、Dana-Farber癌症研究所和马萨诸塞州综合医院，这是招募少数民族患者进行早期试验的主要障碍。从历史上看，我们每年15，000名新患者中有8%来自少数民族社区，进入我们早期临床试验的患者中有6-8%是少数民族。为了解决转诊率低的问题，我们建议建立一个系统，加快转诊病人从社区医学肿瘤实践在剑桥医院。哈佛医学院教师丽莎·魏斯曼博士是剑桥15个社区健康中心网络剑桥健康联盟每年400例新癌症病例的主要护理提供者。她的实践服务于大部分（70%）少数民族人口，其中不到5人被转介到学术健康中心进行临床试验，Weissmann博士将与DF/HCC的实验治疗计划合作，建立一个简化的，基于导航的DF/HCC转介系统，每年转介40名患者到我们的医院进行早期药物试验。该系统将包括以下内容：（1）剑桥医院的实践导航员，负责与DF/HCC的早期试验办公室直接联系，（2）为从剑桥医院来到DF/HCC的患者提供旅行和日间护理的基金，（3）将扩展到Weissmann博士办公室的在线协议信息系统（Oncpro），提供关于开放方案和资格要求的最新信息，（4）在剑桥和DF/HCC可用的西班牙语、葡萄牙语和克里奥尔语/法语的文化相关文献和信息，（5）确保剑桥和DF/HCC工作人员之间协调工作的广泛计划，以及对DFIHCC工作人员进行文化敏感性培训，以及（6）评估应计费用、转诊处理和患者满意度，并对现有满意度调查进行改进。

DESCRIPTION (provided by applicant) This application addresses the low accrual rates of minorities to early (Phase I - Phase II) cancer clinical trials. We have identified low referral rates of minority patients to the hospitals comprising the Dana-Farber/Harvard Cancer Center, a consortium of the Beth Israel Deaconess Hospital, Brigham and Women's Hospital, the Dana-Farber Cancer Institute, and the Massachusetts General Hospital, as a major barrier to recruitment of minority patients to early phase trials. Historically, eight percent of our 15,000 new patients each year come from minority communities, and 6-8% of patients entering our early clinical trials are minorities. To address the problem of low referral rates, we propose to establish a system for expediting referral of patients from community medical oncology practice at the Cambridge Hospital. Dr. Lisa Weissmann, a member of the Harvard Medical School faculty, is the primary provider of care for 400 new cases of cancer each year, as referred from the Cambridge Health Alliance, a network of 15 community health centers in Cambridge. Her practice serves a largely (70 percent) minority population, fewer than 5 of whom are referred to academic health centers for clinical trials, Dr. Weissmann will partner with the Experimental Therapeutics Program of the DF/HCC to establish a simplified, navigator based referral system to the DF/HCC, with the object of referring 40 patients per year to our hospitals for early drug trials. The system will contain the following elements: (1) a practice based navigator at Cambridge Hospital, who will be responsible for making direct contacts with the an Early Trials Office at the DF/HCC, (2) a fund to provide travel and day care for patients coming to the DF/HCC from Cambridge Hospital, (3) an on-line protocol information system (Oncpro) to be extended to Dr. Weissmann's office, providing up to the date information on protocols open and eligibility requirements, (4) culturally relevant literature and information in Spanish, Portuguese, and Creole/French, available in Cambridge and at DF/HCC, (5) an extensive program to ensure coordination of efforts between Cambridge and the DF/HCC staffs, and training in cultural sensitivity for DFIHCC staff, and (6) an evaluation of accrual, disposition of referrals, and patient satisfaction, with refinement of existing satisfaction surveys.