Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10116333
• 负责人: Elizabeth Fox
• 金额: $ 14.74万
• 依托单位: ST. JUDE CHILDREN'S RESEARCH HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10116333
• 关键词: Adopted; Behavioral Research; Biometry; Cancer Center Support Grant; Charge; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Committee Members; Committee Membership; Communication; Comprehensive Cancer Center; Data; Development; Discipline; Disease; Documentation; Enrollment; Ensure; Feasibility Studies; Funding; Goals; Individual; Institutional Review Boards; Late Effects; Malignant Neoplasms; Monitor; Monitoring Clinical Trials; Oncology; Peer Review; Performance; Pharmacology; Policies; Principal Investigator; Process; Protocols documentation; Research; Research Design; Research Personnel; Review Committee; Role; Safety; Saint Jude Children' s Research Hospital; Science; Scientific Evaluation; Specific qualifier value; System; Time; Translational Research; base; design; empowered; falls; improved; meetings; participant safety; patient safety; programs; prospective; protocol development

ABSTRACT–Protocol Review and Monitoring System The conduct and oversight of the lifecycle of clinical trials and the safety of participants are achieved through well-defined processes in study development, review, and performance. In addition to the important roles of the principal investigator, sub-investigator(s), research team(s), and the St. Jude Comprehensive Cancer Center (SJCCC) programs to this endeavor, the Clinical Trials Scientific Review Committee (CT-SRC) is at the core of this process. The CT-SRC is charged with the Protocol Review and Monitoring System (PRMS). The CT-SRC reviews all new prospective clinical trials, which have been first discussed within the pertinent SJCCC Program to ensure that they are aligned with the respective Program's scientific goals. If so, the trial is prioritized among the Program's other competing protocols. After programmatic review and endorsement, the CT-SRC reviews the scientific rationale, feasibility, and study and biostatistical designs and oversees the progress of all institutional protocols to ensure that the initial study design, timely accruals, and stopping criteria are followed and that patient safety is maintained. In addition, the CT-SRC is empowered to modify the conduct of studies and close them, as needed. Committee members include individuals with expertise in clinical research, oncology disciplines, biostatistics, and translational sciences. In July 2012, the CT-SRC implemented a Concept Submission and Review process to precede full protocol development. Additional changes made during the funding period include adopting a formal reviewer worksheet to focus the fundamental review criteria and improve documentation, formalizing a policy for accrual monitoring by the CT-SRC, strengthening the committee's membership with inclusion of additional senior researchers, and implementing the Late Effects and Behavioral Research Subcommittee. Staff in the Central Protocol and Data Monitoring Office assist principal investigators with electronic submissions to the review committees and prepare documents for the CT-SRC. They also coordinate the meetings and communications between the investigators and the CT-SRC. The CT- SRC acts independently of the St. Jude Institutional Review Board and the safety oversight processes (i.e., the external Data Safety and Monitoring Board and the Internal Monitoring Committee). During fiscal year (FY) 2015– FY2017, the CT-SRC reviewed and approved the prioritization of 109 new cancer studies and reviewed 73 concepts. Sixty-two (57%) of the new studies were SJCCC investigator–initiated, externally peer-reviewed trials. Of the 109 studies reviewed, 8 (7%) were disapproved or tabled. During this same period, the CT-SRC monitored 382 studies for accrual and 775 for scientific progress, including studies closed to accrual but not yet completed. During this same period, 75 studies were closed, 8 of which because of low accrual. In summary, the PRMS evaluates and monitors all prospective clinical trials for scientific merit and alignment with the goals of the SJCCC, ensures that the aims of the protocols are on track for completion within the estimated time frames, and determines their relevance to contemporaneous science.

摘要-方案审查和监测系统 临床试验生命周期的实施和监督以及参与者的安全通过以下方式实现： 明确定义的研究开发、审查和执行过程。除了发挥重要作用外， 主要研究者、助理研究者、研究团队和圣犹达综合癌症中心 临床试验科学审查委员会（CT-SRC）的核心是 这个过程CT-SRC负责方案审查和监测系统（PRMS）。CT-SRC 审查所有新的前瞻性临床试验，这些试验首先在相关SJCCC项目中讨论 以确保它们与各自计划的科学目标保持一致。如果是这样，试验将优先进行 该计划的其他竞争协议。在方案审查和核准后，CT-SRC审查 科学原理，可行性，研究和生物统计设计，并监督所有的进展 机构方案，以确保遵循初始研究设计、及时应计和停止标准 并确保患者安全。此外，CT-SRC有权修改研究的进行 并根据需要关闭它们。委员会成员包括具有临床研究、肿瘤学 学科，生物统计学和转化科学。2012年7月，CT-SRC实施了一个概念， 提交和审查过程先于完整的方案制定。会议期间作出的其他改动 资助期包括采用正式的评审员工作表，以集中基本评审标准， 改进文件编制，正式确定CT-SRC权责发生制监测政策，加强 委员会的成员包括更多的高级研究人员，并实施后期效应， 行为研究小组委员会。中央礼宾和数据监测办公室的工作人员协助校长 研究者向审查委员会提交电子文件，并为CT-SRC准备文件。 他们还协调调查员与CT-SRC之间的会议和沟通。CT- SRC独立于圣犹达机构审查委员会和安全监督流程（即，的 外部数据安全和监测委员会和内部监测委员会）。2015财年（FY）- 2017财年，CT-SRC审查并批准了109项新癌症研究的优先顺序，并审查了73项 理念的62项（57%）新研究是SJCCC制药商发起的外部同行评审试验。 在回顾的109项研究中，8项（7%）未被批准或提交。在同一时期，CT-SRC监测了 382项研究用于应计，775项研究用于科学进展，包括接近应计但尚未完成的研究。 在同一时期，有75项研究被关闭，其中8项是因为累积率低。总之，PRMS 评估和监测所有前瞻性临床试验的科学价值和与目标的一致性， 确保各项议定书的目标如期在预计时限内完成， 决定了它们与当代科学的相关性。