Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 9924333
• 负责人: Kathleen N. Moore
• 金额: $ 22.86万
• 依托单位: UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
• 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/9924333
• 关键词: 21 year old; Address; African American; American Indians; Cancer Center; Cancer Center Support Grant; Cancer Patient; Catchment Area; Child; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Conduct Clinical Trials; Data; Development; Elderly; Enrollment; Ensure; Female; Goals; Hispanics; Information Systems; Institutes; Institution; Intervention; Lead; Malignant Childhood Neoplasm; Minority; Monitor; Nursing Research; Oklahoma; Participant; Patient-Focused Outcomes; Patients; Pediatric Oncology; Pediatric Oncology Group; Policies; Population; Quality Control; Reporting; Research; Research Personnel; Research Support; Risk; Rural; Rural Population; Safety; Services; Site; Therapeutic Trials; Time; Training; Translational Research; Tribes; Underserved Population; Uninsured; United States National Institutes of Health; Woman; base; cancer clinical trial; cancer health disparity; clinical trial participant; data integrity; data management; design; efficacy clinical trial; improved; improved outcome; participant safety; programs; recruit; safety study; sound; standard of care; treatment trial

CLINICAL PROTOCOL AND DATA MANAGEMENT – ABSTRACT A centralized Clinical Trials Office (CTO) oversees all Clinical Protocol and Data Management (CPDM) functions at the Stephenson Cancer Center (SCC), with the goal of supporting SCC investigators in the design, development, conduct and reporting of all aspects of clinical research in an efficient, compliant and scientifically focused manner. CTO staff perform regulatory and compliance, data management, research nursing and study coordination, information systems and data support, research finance, and admin support functions to ensure timely initiation, conduct and completion of trials with effective quality control and training functions. Over the past five years, the SCC has accrued 8,083 patients to clinical trials, including 2,531 enrollments to interventional treatment, 1,015 to other interventional and 4,537 to non-interventional trials. The SCC's exceptional track record of accrual to NCTN interventional treatment trials led to its being designated an NCTN Lead Academic Participating Site (LAPS) in 2014. The SCC places the highest priority on ensuring the safety of subjects participating in clinical trials and on the quality of data obtained from clinical and translational research. The SCC has a written Data and Safety Monitoring Plan (DSMP) that describes the oversight of study conduct, participant safety and integrity of data for all clinical trials at the SCC, and particularly for IITs and those studies for which a DSMP does not already exist. A standing DSM Committee meets quarterly to fulfill this important monitoring function. The SCC places a high priority on the recruitment and retention of women, minorities and other underserved populations for clinical trial participation as a way to address Oklahoma's significant cancer health disparities. The SCC has instituted a number of focused initiatives designed to accomplish this aim, with a particular focus on recruiting the state's large and underserved American Indian (AI) population for clinical trial participation. The SCC's AI Patient Navigation Program has served 1,554 AI cancer patients from 54 different tribes over the past five years, helping to facilitate the enrollment of 343 AI patients to interventional and 263 to non- interventional trials. Other initiatives have been implemented to promote the inclusion of rural, under- and uninsured, African American, Hispanic, elderly and female patients on clinical trials. The SCC is committed to the NIH Policy of including children (subjects less than 21 years of age) in all appropriate clinical research supported by the NIH. A primary goal of the SCC's Pediatric Oncology Department is recruiting and retaining children to participate in clinical trials as a way of advancing ideas and raising the standard of care for this population. This group has maintained an active record in the design and conduct of pediatric cancer clinical trials, both the Children's Oncology Group (COG) and IIT, to accomplish this goal. It has consistently been in the top quartile of COG institutions for enrollment in therapeutic trials.

临床方案和数据管理-摘要