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Clinical Trial Operations

临床试验操作

基本信息

批准号：
9124848
负责人：
Annick Desjardins
金额：
$ 14.05万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
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/9124848
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 Pathology Patient Recruitments Patient-Focused Outcomes Patients 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-Lymphocyte Testing Therapeutic Therapeutic Clinical Trial Tissues Training Translating Translational Research Translations United States Food and Drug Administration Universities Vaccines Work base biobank chimeric antigen receptor 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 peptide vaccination pre-clinical protocol development quality assurance receptor research study screening temozolomide tumor

项目摘要

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所需的领导和专业知识