Protocol Review & Monitoring System (PRMS)

方案审查

• 批准号: 9792765
• 负责人: Sanjay Goel
• 金额: $ 7.16万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9792765
• 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).

项目摘要 - 方案审查和监测系统 方案审查和监测系统 (PRMS) 为所有临床和治疗提供科学监督 阿尔伯特·爱因斯坦癌症中心 (AECC) 进行的转化研究。执行 PRMS 功能 由方案审查和监测委员会 (PRMC) 负责，该委员会是一个多学科小组，其成员 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 对所有机构研究者发起的和行业内的机构进行完整的科学、可行性和行政审查 赞助癌症相关协议。 PRMC 并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协议，以及 NCI 癌症治疗评估计划或癌症控制协议支持的临床研究协议 审查委员会。所有经过事先同行评审的 NCI 赞助方案都会经过快速审查 对可行性和与其他试验重叠的资格进行行政审查。 PRMC 的职能是 与机构审查委员会（IRB）互补，其重点是保护人类受试者， 并与 AECC 数据安全监测委员会 (DSMC) 分开。 PRMC 确保所有 试验有适当的数据安全和监测计划；数据和安全监控功能是 DSMC 的责任。初步审查制度分为两个阶段，首先由主管部门批准 疾病或模式导向的临床研究领导者（CRL）和临床研究副主任， 随后由 PRMC 进行审查。这个两阶段审查流程通过以下方式提高效率：(i) 减少工作人员在以下方面的工作量： 制定科学价值较低的方案和 PRMC 应用材料，(ii) 减少从 从概念批准到方案激活，以及 (iii) 减少由 委员会。过去 3 年（2015 年 7 月 1 日至 2018 年 6 月 30 日），激活了 442 个新协议，其中 306 个 干预（15% 机构干预）和 136 次不干预（85% 机构干预）。