GYNECOLOGIC ONCOLOGY GROUP

说明（由申请人提供）：本申请为妇科肿瘤组（GOG） CCOP研究基地申请。妇科肿瘤组是妇科癌症治疗的首要临床试验组，并制定了积极的癌症预防和控制计划。妇科肿瘤学组的组成包括妇科肿瘤学家、内科肿瘤学家、放射肿瘤学家、病理学家、护理肿瘤学家、生物统计学家、实验室科学家、行为科学家、流行病学家等学科。由妇科肿瘤学家领导的社区调查小组的附属网络加强了GOG。该网络由小型大学和/或大型社区医院组成，通过增加现有和新的CCOP组织的贡献，为癌症预防试验的患者招募和登记提供更多机会，应作为预防项目的重要补充。按照典型的多地点肿瘤医学合作小组组成的CCOP机构将有机会将患者纳入GOG开发的治疗和预防试验。然而，许多未来的预防研究将需要获得以前在CCOP机构中未见过的患者群体。在他们适应这些新挑战的过程中，GOG中已经存在的附属网络将为预防项目的成功提供支持和领导。在以往作为研究基地的经验中，GOG的cccop机构已经达到了治疗目标。由于CCOPs未能达到预防目标，GOG失去了研究基地的地位。CCOP和预防会员妇科肿瘤附属机构的联合应该纠正以前的不足。患者收益：在先前的研究基地资助下，1997年至1999年，每年治疗试验的患者收益都令人满意。在预防方面，cccop机构没有达到规定的标准。虽然这一经验表明，政府间工作组在癌症预防研究方面的要求可能不同于其他研究基地的要求，但它也表明，有些癌症预防工作组组织能够应对这一挑战。调整所需的时间比预期的要长。但是，在现行的RFA中有一项规定，允许将合作临床试验组织的成员指定为预防成员。

DESCRIPTION (provided by applicant): This application is for the Gynecologic Oncology Group (GOG) CCOP Research Base. The Gynecologic Oncology Group is the premier clinical trial group in treatment of gynecologic cancers and has developed an active cancer prevention and control program. The composition of the Gynecologic Oncology Group includes gynecologic oncologists, medical oncologists, radiation oncologists, pathologists, nurse oncologists, biostatisticians, laboratory scientists, behavioral scientists, epidemiologists and other disciplines. The GOG is strengthened by an affiliate network of community-based investigative teams led by gynecologic oncologists. This network consists of small university and/or large community hospitals and should serve as a significant supplement in the prevention program by augmenting contributions from existing and new CCOP organizations in providing enhanced opportunities for recruitment and enrollment of patients into cancer prevention trials. The CCOP institutions formed along the lines of typical multi-site medical oncology cooperative groups will find opportunities to enter patients into treatment and prevention trials developed by the GOG. However, many of the future prevention studies will require access to patient groups previously not seen in CCOP institutions. As they adjust to these new challenges, the affiliate network already in place in the GOG will provide support and leadership in making the prevention program successful. In previous experiences as a Research Base, the GOG's CCOP institutions have met treatment goals. The GOG lost its Research Base status due to failure of the CCOPs to meet prevention goals. The combination of CCOP and Prevention Member Gynecologic Oncology Affiliate institutions should correct that previous deficit. Patient Accrual: Under the previous Research Base funding, patient accrual to treatment trials was satisfactory for each year of the grant - 1997 through 1999. In terms of prevention, the CCOP institutions did not meet the standards provided. While that experience showed that the requirements of the GOG in terms of cancer prevention studies may be different from those developed by other Research Bases, it also showed that there were CCOP organizations that could meet the challenge. The time requirement for adjustment was longer than anticipated. However, there is a provision in the current RFA allowing the designation of members of the cooperative clinical trial organization as Prevention Members.