Clinical Trials and Information Management System
Clinical Trials and Information Management System
批准号:
8844747
负责人:
CLAUDINE VALMONTE
金额:
$110.0万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2011
资助国家:
美国
项目状态:
已结题
起止时间:
2011-05-01 至 2015-04-30
关键词:
Advisory CommitteesCancer Therapy Evaluation ProgramClinical ResearchClinical TrialsClinical Trials Cooperative GroupClinical Trials Informatics SystemContractorContractsCooperative Group ProgramData AnalysesDiagnosis Clinical TrialsDivision of Cancer Treatment and DiagnosisEnsureEvaluationExtramural ActivitiesGrantGroup MeetingsNational Cancer Advisory BoardRecommendationResearch PersonnelU-Series Cooperative Agreementscancer diagnosiscancer therapydrug developmentmeetingsmolecular oncologyprogramsworking group
中文摘要
癌症治疗评估项目(CTEP)负责癌症治疗和诊断部(DCTD)支持的大多数校外临床试验的管理、协调和科学审查。这些项目包括DCTD临床试验合作小组项目的活动、早期药物开发项目合作协议和合同持有人、研究者发起的与癌症治疗相关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,重组NCI的临床试验企业,以实现分子肿瘤学在21世纪的前景。NCI的临床试验协调中心(CCCT)指导CTWG建议的实施。CTEP与CCCT合作,领导实施科学指导委员会,以提高临床试验的科学质量和优先级。
英文摘要
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.
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).
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