CLINICAL TRIALS AND INFORMATION MANAGEMENT SUPPORT

临床试验和信息管理支持

• 批准号: 10176306
• 负责人: CLAUDINE VALMONTE
• 金额: $ 384.99万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-16 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10176306
• 关键词: Advisory Committees; Cancer Therapy Evaluation Program; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Contractor; Contracts; Cooperative Group Program; Data Analyses; Division of Cancer Treatment and Diagnosis; Ensure; Evaluation; Extramural Activities; Grant; Group Meetings; Information Management; Investigation; National Cancer Advisory Board; Program Development; Recommendation; Research Personnel; Time; U-Series Cooperative Agreements; cancer therapy; clinical center; clinical implementation; drug development; meetings; molecular oncology; programs; working group

The purpose of this contract is to provide support to the CTEP and CCCT Professional Staff in the evaluation, coordination and oversight of clinical trial concepts and studies as they develop. The Contractor will also be involved with the acquisition, review and analysis of data and information which result from CTEP-sponsored extramural clinical research, providing project management support to ensure that CTEP-sponsored trials are reviewed and activated in a timely manner, and providing administrative support for the coordination and oversight of steering committee meetings, task force and working group meetings, concept evaluations, and Clinical Trials Planning meetings (CTPMs). The Cancer Therapy Evaluation Program (CTEP) is responsible for the administration, coordination, and scientific review of most of the extramural clinical trials supported by the Division of Cancer Treatment and Diagnosis (DCTD). These programs include the activities of the DCTD Clinical Trials Cooperative Group Program, the Early Drug Development Program cooperative agreement and contract holders, the recipients of investigator-initiated grants and cooperative agreements relating to cancer treatment and the recipients of investigational agents. In addition, CTEP is implementing recommendations made by the National Cancer Advisory Board's Clinical Trials Working Group (CTWG) to restructure the NCI's clinical trials enterprise to realize the promise of molecular oncology in the 21st century. NCI's Coordinating Center for Clinical Trials (CCCT) guides the implementation of the CTWG recommendations. CTEP collaborates with CCCT in leading the implementation of Scientific Steering Committees to enhance scientific quality and prioritization of clinical trials.

本合同的目的是为CTEP和CCCT专业人员提供支持，以评估，协调和监督临床试验概念和研究的发展。承包商还将参与CTEP申办的校外临床研究的数据和信息的获取、审查和分析，提供项目管理支持以确保CTEP申办的试验得到及时审查和启动，并为指导委员会会议、工作队和工作组会议、概念评估、临床试验计划会议（CTPM）。 癌症治疗评估计划（CTEP）负责癌症治疗和诊断部门（DCTD）支持的大多数院外临床试验的管理、协调和科学审查。这些计划包括DCTD临床试验合作小组计划的活动，早期药物开发计划合作协议和合同持有人，与癌症治疗相关的赞助商发起的赠款和合作协议的接受者以及研究药物的接受者。此外，CTEP正在实施国家癌症咨询委员会临床试验工作组（CTWG）提出的建议，以重组NCI的临床试验企业，实现世纪分子肿瘤学的承诺。NCI的临床试验协调中心（CCCT）指导CTWG建议的实施。CTEP与CCCT合作，领导科学指导委员会的实施，以提高临床试验的科学质量和优先顺序。