Protocol Review & Monitoring System (PRMS)

方案审查

• 批准号: 10228653
• 负责人: Sanjay Goel
• 金额: $ 7.22万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-06-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10228653
• 关键词: Albert Einstein Cancer Center; Cancer Center; Cancer Control; Cancer Therapy Evaluation Program; Clinical Research; Clinical Research Protocols; Collaborations; Data; Disease; Eligibility Determination; Ensure; Equipment; Funding; Funding Agency; Goals; Human Resources; Industry; Institutional Review Boards; Intervention; Left; Malignant Neoplasms; Manuals; Modality; Monitor; Peer Review; Pharmacologic Substance; Policies; Procedures; Process; Protocols documentation; Research Personnel; Review Committee; Safety; Specific qualifier value; System; Therapeutic; Time; Translational Research; United States National Institutes of Health; Update; Work; drug development; expedited review; experience; human subject protection; interest; investigator-initiated trial; meetings; member; multidisciplinary; patient population

PROJECT SUMMARY - PROTOCOL REVIEW AND MONITORING SYSTEM The Protocol Review and Monitoring System (PRMS) provides scientific oversight of all clinical and translational research performed at the Albert Einstein Cancer Center (AECC). PRMS functions are carried out by the Protocol Review and Monitoring Committee (PRMC), a multidisciplinary group whose members have expertise and experience in therapeutics, drug development, and translational science. The PRMC performs a complete scientific, feasibility, and administrative review of all institutional investigator-initiated and industry- sponsored cancer-related protocols. The PRMC does not duplicate traditional peer review, which includes peer-reviewed protocols supported by the various NIH mechanisms, other approved funding agencies, and clinical research protocols supported by NCI's Cancer Therapy Evaluation Program or Cancer Control Protocol Review Committee. All NCI-sponsored protocols that have undergone prior peer review undergo an expedited administrative review for feasibility and overlapping eligibility with other trials. Functions of the PRMC are complementary to the Institutional Review Board (IRB), which focuses on the protection of human subjects, and separate from those of the AECC Data Safety Monitoring Committee (DSMC). The PRMC ensures that all trials have appropriate data safety and monitoring plans in place; data and safety monitoring functions are the responsibility of the DSMC. The system for initial review comprises 2-stages, starting first with approval by a disease or modality-oriented clinical research leader (CRL) and Associate Director for Clinical Research, followed by review by the PRMC. This 2-stage review process increases efficiency by (i) reducing staff effort in developing protocols and PRMC application materials of lesser scientific merit, (ii) reducing the time from concept approval to protocol activation, and (iii) decreasing the volume of protocols reviewed by the committee. Over the last 3-years (7/1/15-6/30/18), there were 442 new protocols activated, including 306 intervention (15% institutional) and 136 non-intervention (85% institutional).

项目总结-方案审查和监测系统 方案审查和监测系统（PRMS）对所有临床和 阿尔伯特·爱因斯坦癌症中心（Albert Einstein Cancer Center，AECC）。执行PRMS功能 议定书审查和监测委员会（PRMC）是一个多学科小组，其成员 在治疗学、药物开发和转化科学方面的专业知识和经验。PRMC执行一项 对所有机构发起和行业发起的所有机构进行全面的科学、可行性和行政审查， 赞助的癌症相关方案。PRMC不重复传统的同行评审，其中包括 由各种NIH机制、其他批准的资助机构支持的同行评审方案，以及 由NCI癌症治疗评估计划或癌症控制方案支持的临床研究方案 审查委员会。所有经过先前同行评审的NCI申办的方案都经过了加速审查。 对可行性和与其他试验重叠的合格性进行行政审查。PRMC的职能是 作为对机构审查委员会（IRB）的补充，IRB的重点是保护人类受试者， 并与AECC数据安全监测委员会（DSMC）的数据安全监测委员会分开。PRMC确保所有 试验有适当的数据安全性和监查计划;数据和安全性监查功能是 DSMC的责任。初步审查制度分为两个阶段，第一阶段由 疾病或模态导向的临床研究负责人（CRL）和临床研究副主任， 然后由PRMC进行审查。这两个阶段的审查过程通过以下方式提高了效率：（i）减少工作人员的工作量， 制定科学价值较低的协议和PRMC应用材料，（ii）减少从 方案启动的概念批准，以及（iii）减少 以马克思在过去3年（2015年7月1日至2018年6月30日），有442项新协议被激活，包括306项 干预（15%机构）和136个非干预（85%机构）。