Overcoming Barriers to Early Phase Clinical Trials

克服早期临床试验的障碍

• 批准号: 6794687
• 负责人: BRUCE ALLAN CHABNER
• 金额: $ 59.94万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6794687
• 关键词: cancer information system; child care; clinical research; clinical trial phase I; clinical trial phase II; community health services; culture; ethnic group; health care model; health care referral /consultation; health care service availability; health disparity; health science research; human subject; human therapy evaluation; medical outreach /case finding; medically underserved population; model design /development; neoplasm /cancer chemotherapy; oncology; patient oriented research; publications; sensitivity training; travel

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.

描述(由申请人提供) 这项申请解决了少数族裔早期(I期-II期)癌症临床试验的低应收率问题。我们发现，少数族裔患者转诊到由Dana-Farber/哈佛癌症中心、贝丝以色列女执事医院、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组成的财团的医院转诊率低，是招募少数族裔患者参加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%来自少数族裔社区，进入我们早期临床试验的患者中有6%-8%是少数族裔。为了解决转介率低的问题，我们建议在剑桥医院建立一个系统，加快从社区肿瘤内科诊所转介病人的速度。根据剑桥健康联盟的建议，哈佛医学院教员丽莎·魏斯曼博士是每年400例新发癌症病例的主要提供者。剑桥健康联盟是一个由剑桥的15个社区卫生中心组成的网络。她的诊所主要服务于少数族裔(70%)，其中不到5人被转诊到学术健康中心进行临床试验，魏斯曼博士将与DF/HCC的实验治疗计划合作，建立一个简化的、基于导航器的DF/HCC转诊系统，目标是每年将40名患者转诊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)剑桥医院的一名实践导航员，他将负责与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)将扩展到魏斯曼博士办公室的在线礼仪信息系统(Oncpro)，提供有关方案开放和资格要求的最新信息，(4)文化相关文献和西班牙语、葡萄牙语和克里奥尔/法语的信息，可在剑桥和DF/HCC获得，(5)广泛的计划，以确保剑桥大学和DF/HCC工作人员之间的努力协调，并对DFICC工作人员进行文化敏感性培训，以及(6)对应计、转诊处理和患者满意度的评估，并完善现有的满意度调查。