Clinical Protocol and Data Management

临床方案和数据管理

基本信息

批准号：
10712887
负责人：
Balazs Halmos
金额：
$ 35.63万
依托单位：
ALBERT EINSTEIN COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
1997
资助国家：
美国
起止时间：
1997-06-01 至 2028-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10712887
关键词：
Binding Budgets Businesses COVID-19 COVID-19 pandemic Cancer Center Cancer Center Support Grant Catchment Area Clinical Cancer Center Clinical Data Clinical Investigator Clinical Protocols Clinical Research Clinical Sciences Clinical Trials Clinical Trials Network Collaborations Community Outreach Conduct Clinical Trials Data Dedications Development Disease Eligibility Determination Employee Enrollment Ensure Equity Ethics Ethnic Origin Faculty Funding Good Clinical Practice Grant Growth Hematology Infrastructure Institution Intervention Investigational Therapies Investments Journals Leadership Malignant Neoplasms Medical center Modality Monitor National Clinical Trials Network Operations Research Outcome Study Patient advocacy Peer Review Phase Physician Executives Principal Investigator Procedures Protocols documentation Publications Race Reporting Research Research Personnel Resources Risk Safety Science Structure Time Training Training and Education Underrepresented Populations Underserved Population cancer clinical trial community engagement data management investigator-initiated trial marginalized population multidisciplinary neuro-oncology operation patient engagement process improvement programs protocol development quality assurance recruit success underserved minority

项目摘要

Program Director/Principal Investigator (Last, First, Middle): Chu, Edward CLINICAL PROTOCOL AND DATA MANAGEMENT - PROJECT SUMMARY/ABSTRACT The Montefiore Einstein Cancer Center (MECC) Clinical Protocol and Data Management (CPDM), which is operationalized through the recently established business unit called the Cancer Clinical Trials Office (CCTO). The CCTO has been created to unify all cancer clinical research operations under one unit with distinct standard operating procedures and workflows to ensure consistency and high-quality research across all departments conducting cancer clinical research at the Montefiore Medical Center. The CCTO provides the centralized administrative and operational structure for cancer related research at MECC. The CCTO also administratively supports the Data and Safety Monitoring Committee, Protocol Review and Monitoring Committee and the Quality Assurance Program. The CCTO has an annual operating budget of $6.5M in 2022 and has expanded our full- time employees to 75+, including existing and planned recruits, who support nine Disease and Modality Teams and over 80 investigators. Since the prior review, the CPDM has undergone a leadership restructuring. Balazs Halmos, MD, was appointed Associate Director for Clinical Science and interim Medical Director of the CCTO in 2021, and Nicholas Shuman, MSN, was recruited in June 2022 to serve as the Senior Director, Cancer Clinical Research Administration and oversee the daily operations of the CCTO. During the last funding period, interventional accruals remained strong in 2019 (559) but due to the COVID-19 pandemic and staff shortages, had a precipitous decline in 2020 (281). In 2021, Interventional accruals rebounded to 447. The CCTO continues to prioritize MECC science and investigator-initiated clinical trials. In 2021, 23.5% of treatment accruals and 36% of interventional enrollments were to institutional trials. The CCTO also supports participation in multiple National Clinical Trials Network studies (38% of treatment accruals in 2021) under the Minority Underserved NCORP grant and our involvement in the NCI Experimental Therapeutics Clinical Trials Network (ET-CTN). New initiatives beyond the creation of the CCTO as a separate business unit include: (1) the development of a Feasibility Committee to increase operational efficiencies and decrease time to activation, (2) through our collaborative efforts with Community Outreach and Engagement we demonstrated continued success in the enrollment of underrepresented groups (URG) (>80% of accruals identify as URG), (3) a restructuring of the Data and Safety Monitoring Committee to conduct monitoring of MECC investigator-initiated trials on a risk- based approach to align with the NCI CCSG PAR, (4) expansion of the Quality Assurance Program, with dedicated staff - Assistant Director of Quality Assurance, and (5) key faculty clinician investigator recruitments in hematology, neuro-oncology and Phase I. OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page

项目总监/首席研究员（最后，第一，中间）：Chu，Edward 临床方案和数据管理 - 项目摘要/摘要蒙特菲奥里爱因斯坦癌症中心 (MECC) 临床方案和数据管理 (CPDM) 通过最近成立的癌症临床试验办公室 (CCTO) 业务部门进行运作。 CCTO 的成立旨在将所有癌症临床研究操作统一到一个具有不同标准的单位下操作程序和工作流程，以确保所有部门的一致性和高质量研究在蒙特菲奥里医疗中心进行癌症临床研究。 CCTO 提供集中的 MECC 癌症相关研究的行政和运营结构。 CCTO 还从行政角度支持数据和安全监测委员会、方案审查和监测委员会以及质量保证计划。 CCTO 到 2022 年的年度运营预算为 650 万美元，并扩大了我们的全面业务范围员工人数达到 75 人以上，包括现有和计划招募的人员，他们支持 9 个疾病和医疗模式团队以及80多名调查员。自上次审查以来，CPDM 进行了领导层重组。巴拉兹 Halmos 医学博士于 2017 年被任命为 CCTO 临床科学副主任兼临时医学主任 2021 年，尼古拉斯·舒曼（MSN）于 2022 年 6 月被招募担任癌症临床高级总监研究管理并监督 CCTO 的日常运作。在上一个资助期内， 2019 年介入应计项目仍然强劲 (559)，但由于 COVID-19 大流行和人员短缺， 2020 年急剧下降（281）。 2021 年，介入性应计费用反弹至 447。CCTO 继续优先考虑 MECC 科学和研究者发起的临床试验。 2021 年，治疗应计费用的 23.5% 和 36% 的干预入组是机构试验。 CCTO 还支持参与多个国家服务不足的少数群体 NCORP 下的临床试验网络研究（2021 年应计治疗的 38%）拨款以及我们参与 NCI 实验治疗临床试验网络 (ET-CTN)。新的除了将 CCTO 作为一个独立的业务部门创建之外，还采取了以下举措：(1) 开发一个可行性委员会提高运营效率并减少启动时间，(2) 通过我们的通过与社区外展和参与的合作努力，我们在以下方面取得了持续的成功代表性不足群体 (URG) 的入学（> 80% 的应计项目被确定为 URG），(3) 重组数据和安全监测委员会对 MECC 研究者发起的风险试验进行监测与 NCI CCSG PAR 保持一致的方法，(4) 扩展质量保证计划，其中专职工作人员 - 质量保证助理总监，以及 (5) 招聘骨干临床医生研究员血液学、神经肿瘤学和第一阶段。 OMB 编号 0925-0001/0002（修订版 03/2020 批准至 02/28/2023）页码