Overcoming Barriers to Early Phase Clinical Trials

描述（由申请人提供）

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.