CP-CTNet Coordinating Center

项目总结/摘要 癌症是美国和世界上发病率和死亡率的主要原因。一种减少 癌症的风险和负担是使用有效和安全的预防剂和干预措施。 根据国家癌症研究所（NCI）癌症预防部（DCP）的说法，这需要 系统地开发癌症预防剂和干预措施，包括三个关键组成部分; i） 用于鉴定药剂的临床前/毒理学研究，ii）已鉴定药剂的早期试验和其他 有希望的干预措施，以及iii）后期的预防药物和干预措施的III期试验， 成功地通过了早期阶段的试验，在一个三条腿的方法。 癌症预防临床试验网络（CP-CTNet）的目标是确定安全有效的 预防剂和干预措施，以促进其进一步的癌症临床开发 预防进一步的临床开发将在第三阶段进行的晚期III期试验中进行， 即国家社区肿瘤学研究计划（NCORP），由DCP的社区支持 肿瘤学和预防试验研究组，以最终降低癌症的风险和负担。为 作为这三条腿方法的第二条腿，CP-CTNet将进行早期试验以评估安全性， 耐受性和癌症预防潜力的药物和干预措施的不同类别确定的第一个 腿，即DCP的癌症临床前药物开发计划（PREVENT）支持临床前/毒理学 这些研究中有许多针对已知在致癌过程中重要的分子或过程。CP- CTNet站点将在DCP和CP-CTNet数据管理的支持下进行这些早期试验， 审计和协调中心（DMACC）。这些试验包括0期（微量给药）、I期（剂量-剂量）、 发现）和II期（初步疗效）临床试验。 为支持这些早期试验，这些试验将由CP-CTNet研究中心单独或作为跨网络进行 试验，CP-CTNet DMACC将协调跨网络活动，并在1） 集中数据管理和报告，2）临床试验稽查，3）行政和后勤 协调，包括在临床试验方法和生物统计学的专业知识，在整个CP-CTNet。此外，本发明还提供了一种方法， CP-CTNet DMACC将在早期阶段癌症预防试验开发中为所有人提供咨询 CP-CTNet试验和跨网络试验的主要统计作用。

Project Summary/Abstract Cancer is the leading cause of morbidity and mortality in the US and in the world. One approach to reducing the risk and burden of cancer is to use preventive agents and interventions that are effective and safe. According to the Division of Cancer Prevention (DCP) at the National Cancer Institute (NCI), this requires the systematic development of cancer preventive agents and interventions, with three critical components; i) preclinical/toxicology studies for identification of agents, ii) early phase trials of identified agents and other promising interventions, and iii) late phase III trials of preventive agents and interventions that have successfully passed through early phase trials, in a three-legged approach. The goal of the Cancer Prevention Clinical Trials Network (CP-CTNet) is to identify safe and effective preventive agents and interventions in order to advance their further clinical development for cancer prevention. Further clinical development is to be undertaken in late phase III trials conducted by the third leg, i.e. the National Community Oncology Research Program (NCORP), supported by the DCP's Community Oncology and Prevention Trials Research Group, to ultimately reduce the risk and burden of cancer. As the second leg of this three-legged approach, the CP-CTNet will conduct early phase trials to assess the safety, tolerability, and cancer preventive potential of agents and interventions of varying classes identified by the first leg, i.e. the DCP's Cancer Preclinical Drug Development Program (PREVENT) support of preclinical/toxicology studies, many of which target molecules or processes known to be important during carcinogenesis. The CP- CTNet Sites will perform these early phase trials supported by the DCP and the CP-CTNet Data Management, Auditing, and Coordinating Center (DMACC). These trials include phase 0 (micro-dosing), phase I (dose- finding), and phase II (preliminary efficacy) clinical trials. To support these early phase trials, which will be conducted by the CP-CTNet sites alone or as cross-Network trials, the CP-CTNet DMACC will coordinate trans-Network activities and provide expertise and resources in 1) centralized data management and reporting, 2) clinical trials auditing, and 3) administrative and logistical coordination, including expertise in clinical trials methodology and biostatistics, across CP-CTNet. In addition, the CP-CTNet DMACC will provide an advisory role in early phase caner prevention trial development for all CP-CTNet trials and the primary statistical role for cross-Network trials.