Clinical Protocol and Data Management

临床方案和数据管理

基本信息

批准号：
10024357
负责人：
Antoinette Wozniak
金额：
$ 49.62万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
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：
1997-09-10 至 2025-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10024357
关键词：
Adult Age Appointment Area Basic Science Cancer Burden Cancer Center Cancer Center Support Grant Catchment Area Child Childhood Clinical Clinical Cancer Center Clinical Data Clinical Investigator Clinical Management Clinical Protocols Clinical Research Clinical Trials Collaborations Communities Community Clinical Oncology Program Community Outreach Conduct Clinical Trials County Data Development Disease Doctor of Philosophy Early Diagnosis Education Education and Outreach Enrollment Ensure Ethnic Origin Female Goals Guidelines Human Subject Research Industry Infrastructure Intervention Intervention Trial Lead Leadership Malignant Neoplasms Minority Minority Enrollment Minority Participation Mission Modality Monitor Monitoring Clinical Trials National Clinical Trials Network Natural Language Processing Oncology Operations Research Palliative Care Patient Care Patient advocacy Patients Pediatric Hospitals Pediatric Oncology Peer Review Pennsylvania Phase Play Procedures Process Quality Control Race Regimen Reporting Research Research Personnel Research Training Safety Services Strategic Planning Supportive care Therapeutic Therapeutic Clinical Trial Therapeutic Trials Time Universities Vendor Woman advocacy organizations base biobank biobehavior cancer clinical trial clinical trial enrollment data management data quality/integrity experience health equity improved innovation investigator-initiated trial male novel oncology program operation patient safety programs recruit screening smartphone Application translational research program trend

项目摘要

Abstract: Clinical Protocol and Data Management (CPDM) Clinical Protocol and Data Management (CPDM) at the UPMC Hillman Cancer Center (HCC) is supported by the Department of Clinical Research Services (CRS). CRS facilitates the development, implementation, coordination, internal data monitoring, and completion of both pediatric and adult oncology-focused trials. CRS supports national, external peer-reviewed, institutional, and industry trials at all phases, involving all treatment modalities, with 413 active trials in 2018, including 266 early phase (Pilot, Phase 1/2), 72 Investigator-Initiated Trials (IITs) of which 43 are developed by HCC investigators, and 96 national trials (DT4). HCC accrued 1,843 patients on interventional trials of whom 745 were on therapeutic trials in CY 2018, and 12,752 Interventional accruals of which 4,197 are therapeutic during the current reporting period. CPDM/CRS supports HCC institutional (i.e., investigator-initiated), multi-center cooperative group/National Clinical Trial Network (NCTN), consortium, and industry-sponsored trials. CPDM leadership was modified in 2018 with the appointment of Antoinette Wozniak, MD, an experienced clinical investigator, as the Associate Director (AD) for Clinical Research to oversee the development of the scientific strategy for HCC and the promotion of investigator- initiated clinical research to take advantage of the strong basic and translational scientific programs at HCC. Also new in 2018, Bhanu Pappu, PhD, MHA, joined as the AD for Clinical Research Operations and provides day-to-day administrative oversight of CRS and executes the strategic plan. Since their arrival in 2018, they have streamlined several processes, started new initiatives to decrease clinical trial activation times, increased staff retention, allocated CPDM staff based on trial complexity, strengthened internal audit processes, and enhanced collaborations with the expansive UPMC community oncology practices. Early trends indicate that clinical trial activation times have decreased significantly and patient enrollment on therapeutic clinical trials has increased by 30% in 2019 compared to 2018. Data and Safety Monitoring is an integral part of the CPDM which is overseen by the Data and Safety Monitoring Committee (DSMC) and supported by the internal audit team as well as the Education and Compliance Office of the University of Pittsburgh. An independent safety team ensures that all disease or modality centers (DMC) across HCC follow the same SOPs for patient safety reporting and submits its reports to the DSMC Chair. Participation of women continues to be high (67% accruals in 2018 are women). Minority participation is stable (5.4%) and closer to the percentage of minority patients seen at HCC, but HCC leadership recognized the need and opportunity to increase minority enrollment, hence various strategies to enhance minority trial participation are outlined in Part III of CPDM. The Pediatric Oncology Program at Children’s Hospital of Pittsburgh is integrated with HCC and recruited 60 patients on clinical trials out of 164 analytical cases in 2018 (37%).

摘要：临床方案和数据管理（CPDM） UPMC Hillman癌症中心（HCC）的临床方案和数据管理（CPDM）得到了支持临床研究服务部（CRS）。 CRS促进了开发，实施，儿科和成人肿瘤学试验的协调，内部数据监测以及完成。 CRS 在各个阶段支持国家，外部同行评审，机构和行业试验，涉及所有治疗模式，2018年有413次主动试验，包括266个早期阶段（飞行员，阶段1/2），72个研究者在其中43个由HCC调查人员开发的试验（IIT）和96个国家试验（DT4）。 HCC累计1,843 介入试验的患者在2018年进行了745例接受治疗试验的患者，介入12,752例在当前报告期间，其中4,197个具有治疗性的应计。 CPDM/CRS支持HCC 机构（即研究人员发起的），多中心教练组/国家临床试验网络（NCTN），财团和行业赞助的试验。 CPDM领导力于2018年被修改经验丰富的临床研究员Antoinette Wozniak，医学博士，临床副主任（AD）监督HCC科学策略的制定和促进研究者的研究 - 开始临床研究，以利用HCC的强大基本和翻译的科学计划。同样在2018年，MHA博士Bhanu Pappu博士加入了临床研究操作的广告，并提供日常行政监督CRS并执行战略计划。自2018年到来以来简化了几个过程，开始了新的计划以减少临床试验激活时间，增加员工保留，根据试用的复杂性分配CPDM员工，加强内部审计流程以及与广泛的UPMC社区肿瘤学实践的合作增强了。早期趋势表明临床试验激活时间已显着改善，并且在热临床试验中的患者入学与2018年相比，2019年的增长30％。数据和安全监控是CPDM的组成部分由数据和安全监测委员会（DSMC）监督，并由内部审计支持团队以及匹兹堡大学的教育与合规办公室。独立的安全团队确保HCC的所有疾病或模态中心（DMC）遵循相同的SOP，以确保患者安全报告并将其报告提交给DSMC主席。女性的参与仍然很高（67％ 2018年的应计是女性）。少数族裔参与是稳定的（5.4％），并且更接近少数群体的百分比患者在HCC上看到了，但HCC领导层认识到增加少数群体的需求和机会 CPDM的第三部分概述了入学率，因此提高少数民族试验参与的各种策略。这匹兹堡儿童医院的儿科肿瘤学计划与HCC融为一体，并招募了60 2018年164例分析病例的临床试验患者（37％）。