Clinical Trial Operations

临床试验操作

• 批准号: 8940300
• 负责人: Annick Desjardins
• 金额: $ 15.07万
• 依托单位: DUKE UNIVERSITY
• 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/8940300
• 关键词: Adult; Avastin; Bioinformatics; Biometry; Brain Neoplasms; Case Report Form; Clinic; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collection; Conduct Clinical Trials; Conflict of Interest; Consent; Consent Forms; Data; Data Analyses; Data Collection; Databases; Dedications; Development; Documentation; Electronics; Enrollment; Ensure; Epidermal Growth Factor; Evaluation; Federal Government; Gliadel; Goals; Grant; Health system; Human; Human Resources; Immune; Immunologic Monitoring; Individual; Informatics; Institutes; Instruction; International; Investigation; Laboratories; Laboratory Finding; Leadership; Malignant - descriptor; Malignant Glioma; Malignant Neoplasms; Malignant neoplasm of brain; Manuscripts; Methods; Monoclonal Antibodies; Mutation; Nurse Practitioners; Nursing Research; Oncolytic viruses; Outcome; Pathology; Patient Recruitments; Patients; Peptides; Phase; Phase III Clinical Trials; Population Heterogeneity; Preparation; Procedures; Process; Protocols documentation; Publications; Qualifying; Quality of life; Radioisotopes; Radiopharmaceuticals; Randomized; Recruitment Activity; Research; Research Design; Research Infrastructure; Safety; Sample Size; Schedule; Services; Side; Specialist; Statistical Models; T-Cell Receptor; T-Lymphocyte; Testing; Therapeutic; Therapeutic Clinical Trial; Tissues; Training; Translating; Translational Research; Translations; United States Food and Drug Administration; Universities; Vaccination; Vaccines; Work; base; biobank; clinical material; cytotoxic radiation; data acquisition; data management; design; electronic data; epidermal growth factor receptor VIII; follow-up; improved; innovation; meetings; member; multidisciplinary; neuro-oncology; novel; novel therapeutics; operation; pre-clinical; protocol development; quality assurance; receptor; research study; screening; temozolomide; tumor

The Clinical Trial Operations Core will provide the leadership and expertise needed to support the clinical research of the four Projects of this SPORE grant. The Clinical Trial Operations Core will be Co-Directed by Dr. Annick Desjardins and Dr. Darell Bigner. Dr. Desjardins will interact with Project leaders to develop clinical trials based upon the data generated from laboratory investigations. The Clinical Trial Operations Core will support the actual conduct of SPORE clinical trials, including providing clinicians, research manager, research nurses, research nurse practitioner, clinical trial coordinators, regulatory personnel and data coordinators. Drs. Desjardins and Bigner will assure the development, successful conduct, and publication of the clinical trials coming from the work of the four Projects by assuring the development of all the required documents for the conduct of the study (e.g., protocols, consent forms, clinical side of IND submission, standard operating procedures, regulatory management, data collection, and data publication). Core B, biostatistical component, will provide advice on the design of experimental and clinical studies, including calculating sample sizes and power; data analysis support (either by performing the analyses within the core or advising qualified personnel within the projects), including the use of appropriate statistical models and applications of statistical test; and, when necessary, the development of novel methods to help interpret results from experiments. Additionally, a member of the biostatistical component will participate in regularly scheduled project meetings to provide statistical/bioinformatics input and assist in preparing the necessary materials for presentation and publication.

临床试验运营核心将提供支持临床试验所需的领导力和专业知识 SPORE 资助的四个项目的研究。临床试验运营核心将由 Dr. 共同指导。 安尼克·德贾丁斯 (Annick Desjardins) 和达雷尔·比格纳 (Darell Bigner) 博士。 Desjardins 博士将与项目负责人互动，开发临床 基于实验室调查产生的数据的试验。临床试验运营核心将 支持SPORE临床试验的实际进行，包括提供临床医生、研究经理、研究人员 护士、研究护士、临床试验协调员、监管人员和数据协调员。博士。 Desjardins 和 Bigner 将确保临床试验的开发、成功进行和发表 来自四个项目的工作，确保开发所有所需文件 研究的进行（例如方案、同意书、IND 提交的临床方面、标准操作 程序、监管管理、数据收集和数据发布）。核心 B，生物统计部分， 将提供有关实验和临床研究设计的建议，包括计算样本量和 力量;数据分析支持（通过在核心内进行分析或向合格人员提供建议 项目内），包括使用适当的统计模型和统计测试的应用；和， 必要时，开发新方法来帮助解释实验结果。另外，一个 生物统计部分的成员将参加定期安排的项目会议，以提供 统计/生物信息学输入并协助准备演示和出版所需的材料。