Early Phase Clinical Research Support

早期临床研究支持

• 批准号: 9645016
• 负责人: Richard James Gilbertson
• 金额: $ 0.37万
• 依托单位: ST. JUDE CHILDREN'S RESEARCH HOSPITAL
• 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/9645016
• 关键词: Angiogenesis Inhibitors; Antibodies; Assimilations; Basic Science; Biological; Budgets; Cancer Center Support Grant; Child; Childhood; Childhood Cancer Treatment; Clinical Nursing Research; Clinical Oncology; Clinical Research; Clinical Research Associate; Clinical Trials; Clinical trial protocol document; Community Clinical Oncology Program; Complement; Comprehensive Cancer Center; Correlative Study; Cytolysis; Data; Data Analyses; Development; Diffuse; Diffuse intrinsic pontine glioma; Disease; Elements; Enrollment; Ensure; Funding; Funding Mechanisms; Genes; Glioma; Hematologic Neoplasms; Industry; Laboratory Research; Leadership; Malignant Childhood Neoplasm; Mission; Neuroblastoma; Nursing Research; Patients; Pharmacology; Phase; Point Mutation; Pontine structure; Principal Investigator; Program Reviews; Protocol Compliance; Protocols documentation; Relapse; Reporting; Research; Research Personnel; Research Support; Resistance; Safety; Saint Jude Children' s Research Hospital; Section 8; Services; Solid Neoplasm; Testing; Toxic effect; Translating; Wages; Work; activated protein C receptor; cancer research center director; chemotherapy; clinically relevant; design; high risk; improved; innovation; interest; investigator-initiated trial; leukemia; member; novel; novel therapeutic intervention; novel therapeutics; programs; sample collection; small molecule inhibitor; success; translational study; treatment strategy

The St. Jude Comprehensive Cancer Center (SJCCC) leadership views the design and implementation of investigator-initiated clinical trials as a top priority. This activity is especially valued when it translates discoveries made in SJCCC basic research laboratories to novel therapies that promise to improve the survival of children with cancer. The EPCRS provides an important mechanism of support this work enabling investigators to conduct high-priority translational studies that are not typically supported by other funding mechanisms. The EPCRS supports clinical research nurses (CRA-RNs) and clinical research associates (CRAs) dedicated to the conduct and completion of these innovative pilot and Phase I investigator-initiated trials within the SJCCC. Clinical research personnel supported by the EPCRS help manage and ensure the success of these protocols by providing a broad range of services including: maintaining protocol-specific research data; ensuring protocol compliance; preparing progress and safety reports; coordinating of specimen collection and compliance with the numerous biological and pharmacological endpoints; and coordinating the abstraction and assimilation of necessary data for analyses and reporting. Many of our EPCRS supported protocols involve an IND or IDE and/or novel agents developed within the SJCCC; thus, additional regulatory functions are required. Candidate trials for EPCRS are first identified within the SJCCC Programs and reviewed and approved by the SJCCC Director and the Associate Director for Clinical Research, who also provide budget oversight. Funding is requested for an appropriate portion of salary support for clinical research nurses, clinical research associates (CRAs), and study coordinators for work supporting EPCRS-eligible trials.

圣裘德综合癌症中心（SJCCC）的领导层认为，设计和实施的化疗启动的临床试验作为一个重中之重。这项活动特别有价值，因为它将SJCCC基础研究实验室的发现转化为有望提高癌症儿童生存率的新疗法。EPCRS提供了支持这项工作的重要机制，使研究人员能够进行其他资助机制通常不支持的高优先级转化研究。EPCRS支持临床研究护士（CRA-RN）和临床研究助理（CRA），致力于在SJCCC内进行和完成这些创新试点和I期临床试验。由EPCRS支持的临床研究人员通过提供广泛的服务来帮助管理和确保这些方案的成功，包括：维护方案特定的研究数据;确保方案合规性;编写进度和安全性报告;协调标本采集和众多生物学和药理学终点的合规性;以及协调分析和报告所需数据的提取和同化。我们的许多EPCRS支持的方案涉及IND或IDE和/或在SJCCC内开发的新药;因此，需要额外的监管职能。EPCRS的候选试验首先在SJCCC项目中确定，并由SJCCC主任和临床研究副主任审查和批准，他们还提供预算监督。要求为临床研究护士、临床研究助理（CRA）和研究协调员提供适当部分的工资支持，以支持符合EPCR条件的试验。