Re-engineering Protocol Implementation and Development (RaPID)

重新设计协议实施和开发 (RaPID)

• 批准号: 8175000
• 负责人: LARRY ARTHUR
• 金额: $ 45万
• 依托单位: LEIDOS BIOMEDICAL RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-26 至 2018-09-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8175000
• 关键词: Advisory Committees; Advocate; CCR; Cancer Center; Cancer Therapy Evaluation Program; Clinical Investigator; Clinical Research; Clinical Trials; Communities; Contracts; DM-Et; Data; Development; Division of Cancer Prevention; Division of Cancer Treatment and Diagnosis; Engineering; Extramural Activities; Funding; Institution; Investigational Drugs; Leadership; National Cancer Institute; Oncologist; Outcome; Patients; Pharmacologic Substance; Phase; Phase III Clinical Trials; Process; Protocols documentation; Quality of life; Recommendation; Reporting; Research Personnel; Resources; Slide; Solutions; Specialist; Speed; System; Time; TimeLine; Translational Research; Universities; Work; base; cancer imaging; cancer research center director; cancer therapy; design; imaging modality; improved; meetings; novel; programs; protocol development; tumor progression; working group

Recent independent analyses of the National Cancer Institute¿s (NCI) clinical trials systems have indicated an urgent need to re-evaluate engrained processes for developing and implementing phase 1-3 protocols (Dilts DM et al. Steps and time to process clinical trials at the Cancer Therapy Evaluation Program. J Clin Oncol 2009 27:1761-1766). It is critical to find novel solutions to speeding up the excessive time it currently takes to activate an NCI-sponsored clinical trial if investigators are to take full advantage of scientific opportunities available today for clinical research. The Division of Cancer Treatment and Diagnosis (DCTD), primarily through its Cancer Therapy Evaluation Program (CTEP) and Cancer Imaging Program (CIP), and the Division of Cancer Prevention sponsor multi-institution clinical trial organizations (NCI Cooperative Groups) that conduct both early phase and late phase multi-institutional trials that evaluate anticancer therapies and imaging modalities designed to improve multiple outcomes including quality of life, delay in cancer progression and overall survival. The NCI also supports a critical network of university-based and free-standing cancer centers that conduct a large number of NCI-supported clinical trials. The focus of this initiative will be on improving the timelines involved in activating NCI-sponsored Cooperative Group phase 3 trials and in activating CTEP-held IND studies of all phases as well as investigator-initiated trials at NCI-designated Cancer Centers. . Based upon recommendations from the Clinical Trials Working Group report (http://restructuringtrials.cancer.gov/files/ctwg-report.pdf), an Operational Efficiency Working Group (OEWG) was constituted under the leadership of an extramural co-chair, Dr. Gabriel Hortobagyi, and an intramural NCI co-chair, Dr. James Doroshow. The OEWG membership was broad and diverse, including 10 Cooperative Group Chairs, 8 Cancer Center Directors, multiple clinical investigators and statisticians, protocol/Trial Specialists, Community Oncologists, representatives from Pharma/Biotech, Patient Advocates, FDA, CMS, CTSU as well as NCI Clinical Trials Leadership and Staff from DCTD, CTEP, DCP, CCR, NCICB, CCCT, and Cancer Centers. The interim report of the OEWG was presented to the Clinical Trials Advisory Committee (CTAC) on November 4, 2009. The report reviewed the current timelines for development of Cooperative Group phase 3 trials (Appendix 1 ¿ slide 1). Based upon these data, the medium time to phase 3 protocol activation is currently 830 days. It is clear that this prolonged development process often leads to trials which accrue poorly due to intervening scientific changes that can cause the original trial question to become stale or less relevant by the time the protocol opens. The OEWG dissected the current process into its components (Appendix 1 ¿ slides 2&3). The phases that require the most improvement encompass concept approval to protocol submission and protocol submission to protocol approval. To improve these timelines, the OEWG recommended a revised process for developing and implementing protocols. All stakeholders involved in the process, Cooperative Groups, NCI ¿designated Cancer Centers, NCI/DCTD/CTEP, NCI/ DCP, and other collaborators such as the FDA and pharmaceutical companies will have to work in concert if the overall process is to improve. Following acceptance by NCI¿s Clinical Trials and Translational Science Advisory Committee (CTAC), a decision was made to implement OEWG¿s recommendations. Most importantly, it was agreed that phase 3 Cooperative Group trials would target 300 days to go from concept receipt to trial activation. While the Groups and CTEP will work together to develop new processes that help achieve the targeted timeline during 2010, it was decided that a deadline of 2 years will become mandatory as of January 1, 2011. All phase 3 trials currently in development will have to meet this 2-year timeline or they will be disapproved. Similarly, for CTEP-held IND phase 1-2 trials, the target was set at 210 days from LOI receipt to trial activation. A firm deadline of 18 months will become mandatory as of January 1, 2011, after which any trial proposal (new or currently in development) that exceeds this deadline would be disapproved irrespective of the reason for the delay. A target of 90 days was set for investigator-initiated trials at Cancer Centers. However, Cancer Centers will determine appropriate deadlines for their studies individually. For the Groups, CTEP and the Cancer Centers to meet these new protocol development timelines, the OEWG made several recommendations regarding the type of additional resources that would be required.

美国国家癌症研究所最近的独立分析¿ (NCI) 临床试验系统表明迫切需要重新评估制定和实施 1-3 期方案的根深蒂固的流程（Dilts DM 等人。癌症治疗评估计划中处理临床试验的步骤和时间。J Clin Oncol 2009 27:1761-1766）如果研究人员要充分利用 NCI 资助的临床试验，那么找到新的解决方案来加快目前启动 NCI 资助的临床试验所需的时间至关重要。癌症治疗和诊断司 (DCTD) 主要通过其癌症治疗评估计划 (CTEP) 和癌症成像计划 (CIP) 以及癌症预防司赞助多机构临床试验。进行早期和晚期多机构试验的组织（NCI 合作小组），评估抗癌疗法和成像模式，旨在改善多种结果，包括生活质量、延迟癌症进展和总体生存率。NCI 还支持一个关键网络。的开展大量 NCI 支持的临床试验的大学和独立癌症中心 该计划的重点将是改善启动 NCI 赞助的合作小组 3 期试验和启动 CTEP 持有的 IND 所涉及的时间表。所有阶段的研究以及研究者在 NCI 指定的癌症中心发起的试验。 根据临床试验工作组报告 (http://restructuringtrials.cancer.gov/files/ctwg-report.pdf) 的建议，在校外联合主席的领导下成立了运营效率工作组 (OEWG)， Gabriel Hortobagyi 博士和 NCI 校内联合主席 James Doroshow 博士 OEWG 成员广泛且多元化，包括 8 个癌症中心的 10 名合作小组主席。董事、多名临床研究人员和统计学家、方案/试验专家、社区肿瘤学家、制药/生物技术代表、患者权益倡导者、FDA、CMS、CTSU 以及来自 DCTD、CTEP、DCP、CCR、NCICB 的 NCI 临床试验领导和工作人员， CCCT 和癌症中心 OEWG 的中期报告于 2009 年 11 月 4 日提交给临床试验咨询委员会 (CTAC)。该报告回顾了当前的时间表。合作组 3 期试验的开发（附录 1 幻灯片 1）根据这些数据，目前 3 期方案激活的中间时间为 830 天，很明显，这种长期的开发过程通常会导致试验效果不佳。干预科学变化可能导致原始试验问题在协议开放时变得陈旧或不太相关。 OEWG 将当前流程分解为各个组成部分（附录 1 ¿幻灯片 2 和 3）中需要改进最多的阶段包括概念批准到方案提交以及方案提交到方案批准。 为了缩短这些时间表，OEWG 建议修订流程以制定和实施方案，所有参与该流程的利益相关者、合作团体、NCI ¿如果要在 NCI 接受后改进整个流程，指定的癌症中心、NCI/DCTD/CTEP、NCI/DCP 以及 FDA 和制药公司等其他合作者必须共同努力。临床试验和转化科学咨询委员会 (CTAC) 决定实施 OEWG¿最重要的是，大家一致认为，第 3 阶段合作小组试验的目标是从概念接收到试验启动需要 300 天，而合作小组和 CTEP 将共同开发新流程，以帮助在 2010 年实现目标时间表。决定自 2011 年 1 月 1 日起强制执行 2 年期限。目前正在开发的所有 3 期试验都必须满足这一 2 年期限，否则将被拒绝批准。 CTEP 举行的 IND 1-2 期试验，目标定为从收到意向书到试验启动的 210 天。自 2011 年 1 月 1 日起，18 个月的严格期限将成为强制性的，在此之后任何试验提案（新的或当前正在进行的）。癌症中心为研究者发起的试验设定了 90 天的目标，超过此期限的将被拒绝。为了使各小组、CTEP 和癌症中心满足这些新方案制定时间表，相关 OEWG 就所需的额外资源类型提出了几项建议。