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） 该申请解决了少数族裔对早期（第一阶段 - 第二阶段）癌症临床试验的应计率低。我们已经确定了少数族裔患者的转介率低，包括达纳 - 法伯/哈佛大学癌症中心，贝丝以色列执事医院，杨百翰和妇女医院，达纳·弗伯尔癌症研究所以及马萨诸塞州妇女医院以及马萨诸塞州妇女医院的财团，作为对少数阶段患者的主要障碍。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，而进入我们早期临床试验的患者中有6％是少数群体。为了解决低转诊率的问题，我们建议建立一个系统，以加快剑桥医院社区医学肿瘤学实践的转诊。哈佛医学院教职员工的成员丽莎·魏斯曼（Lisa Weissmann）博士是每年400例新癌症病例的主要提供商，这是剑桥剑桥卫生联盟（Cambridge Health Alliance）的提及，该网络是剑桥15个社区卫生中心的网络。她的做法主要服务于少数民族（70％），其中不到5个被转诊给了临床试验的学术保健中心，Weissmann博士将与DF/HCC的实验治疗学计划合作，以建立一个基于Navigator的简化，基于导航器的转介系统，向DF/HCC建立每年40名患者的临时药物，以供我们提供早期药物的40名患者。该系统将包含以下要素：（1）剑桥医院的基于练习的导航员，他将负责与DF/HCC的早期试验办公室直接联系，（2）一项基金，为从剑桥医院提供DF/HCC的患者提供旅行和日托，（3）临时供应及以上的协议（3）供应范围，以供供应及以上的仪式，以供供应范围内的供应，供应范围内的供应仪式，供应范围供应供应。资格要求，（4）在剑桥和DF/HCC上提供的西班牙语，葡萄牙语和克里奥尔语/法语的文化相关文献和信息满意度调查。