Clinical Trial Operations Core

临床试验运营核心

• 批准号: 10705233
• 负责人: Annick Desjardins
• 金额: $ 26.63万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-24 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10705233
• 关键词: Antigens; Avastin; Bioinformatics; Biometry; Bone Marrow; Brain; Brain Neoplasms; Cancer Vaccines; Case Report Form; Certification; Clinic; Clinical; Clinical Data; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Collection; Conduct Clinical Trials; Conflict of Interest; Consent; Databases; Dedications; Development; Doctor of Medicine; Doctor of Philosophy; Documentation; Electronics; Enrollment; Ensure; Evaluation; Family; Federal Government; Gliadel; Glioblastoma; Glioma; Goals; Health system; Immune; Immunologic Monitoring; Individual; Infrastructure; Interdisciplinary Communication; International; Investigation; Laboratories; Laboratory Finding; Leadership; MGMT gene; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of brain; Manuscripts; Methodology; Mutate; Newly Diagnosed; Pathology; Patient Recruitments; Patient-Focused Outcomes; Patients; Population Heterogeneity; Preparation; Primary Brain Neoplasms; Procedures; Process; Protocols documentation; Publications; Regulatory T-Lymphocyte; Research; Research Design; Research Support; Safety; Services; Specialist; T-Lymphocyte; Therapeutic Clinical Trial; Tissues; Training; Translating; Translational Research; United States Food and Drug Administration; Universities; biobank; career; clinical material; cost effective; data acquisition; data management; electronic data; follow-up; improved; innovation; interdisciplinary collaboration; meetings; monocyte; multidisciplinary; neoantigen vaccine; neuro-oncology; operation; participant enrollment; patient population; programs; promoter; protocol development; quality assurance; recruit; screening; temozolomide; translational goal; vaccine strategy

ABSTRACT – Clinical Trial Operations Core (Core 2) The Clinical Trial Operations Core provides critical research support to promote seamless and efficient development, recruitment and conduct of the clinical trials in the Duke Brain SPORE's three projects and clinical studies proposed by Developmental and Career Enhancement awardees. Bringing strong expertise in neuro-oncology and clinical trial operations to the SPORE, the Core ensures the safe and efficient conduct of clinical studies (Aim 1) and recruitment, consent and enrollment of a diverse group of subjects for biospecimen collection and clinical studies (Aim 2). Through these Aims, the Core provides critical oversight of the full range of clinical trial activities, including study design, protocol preparation, research staff training, patient recruitment, patient evaluation during treatment and follow-up, assessment and treatment of complications, and evaluation of patient outcomes. To ensure rigorus trial conduct, the Core mainatins a full portfolio of standard operating procedures (SOPs). In addition, the Core is fully integrated with other Duke Brain SPORE components to ensure seamless research coordination. For example, in partnership with the Administrative Core, this Clinical Trial Operations Core provides regulatory specialists to meet the requirements of the federal government, Duke University Health System (DUHS), and Duke Cancer Institute (DCI) and avoid conflict of interest (COI). This Core also collaborates with the Biostatistics and Bioinformatics Core (Core 1) in the development of the protocol electronic case report forms (eCRFs), study database, data management, quality assurance, and summarization of clinical data for presentation at international meetings and manuscript publications. Finally, the Clinial Trial Operations Core supplies electronic data acquisition and documentation services for the Biostatistics and Bioinformatics Core (Core 1) and facilitates tissue biobanking with the Biospecimen and Immune Monitoring Core (Core 3). By enchancing interdisciplinary communictation and collaboration in this way, the Core supports the the SPORE's commitment to both translate laboratory findings to the clinic and collect clinical material to be studied in the laboratory.

摘要-临床试验操作核心(核心2) 临床试验运营核心提供关键的研究支持，以促进无缝和高效 开发、招募和进行杜克大学脑孢子三个项目的临床试验和 由发展和职业提升奖获得者提出的临床研究。带来了强大的专业知识 神经肿瘤学和临床试验操作到孢子，核心确保安全和高效地进行 临床研究(目标1)和招募、同意和登记生物样品的不同受试者群体 收集和临床研究(目标2)。通过这些目标，核心提供了对整个范围的关键监督 临床试验活动，包括研究设计、方案准备、研究人员培训、患者 招募，治疗和随访期间的患者评估，并发症的评估和治疗， 以及对患者结果的评估。为了确保严格的审判进行，核心维护了完整的 标准操作程序(SOP)。此外，核心与其他杜克脑孢子完全整合在一起 组件，以确保无缝的研究协调。例如，与行政部门合作 核心，这个临床试验运营核心提供监管专家，以满足联邦 政府、杜克大学卫生系统(DUHS)和杜克癌症研究所(DCI)，避免 利息(COI)。该核心还与生物统计和生物信息学核心(核心1)在 制定议定书电子病例报告表、研究数据库、数据管理、质量 临床数据的保证和汇总，以供在国际会议和手稿中提交 出版物。最后，临床试验业务核心提供电子数据采集和文件 为生物统计和生物信息学核心(核心1)提供服务，并通过 生物菌素和免疫监测核心(核心3)。通过加强跨学科交流和 通过这种方式的合作，核心支持孢子的承诺，以翻译实验室的发现 并收集临床资料，在实验室进行研究。