Early Phase Clinical Research Support

早期临床研究支持

• 批准号: 9750159
• 负责人: Christian Diego Rolfo
• 金额: $ 14.02万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 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/9750159
• 关键词: Address; Authorship; Baltimore; Biological Assay; Biometry; Cancer Center; Cancer Center Support Grant; Cigarette; Clinical; Clinical Research; Clinical Trials Data Monitoring Committees; Contracts; County; Data; Detection; Development; Devices; Diagnosis; Doctor of Medicine; Doctor of Philosophy; Flow Cytometry; Funding; Funding Agency; Future; Genomics; Goals; Grant; Guidelines; Hormone Responsive; Human; Human Resources; Image; Industry; Infrastructure; Institutes; Institutional Review Boards; Intervention; Investigational Therapies; Laboratories; Malignant Neoplasms; Maryland; Medical; Medical center; Molecular Biology; Pathology; Patients; Pharmacy Schools; Phase; Population Sciences; Preparation; Prevention; Prevention strategy; Process; Protocols documentation; Public Health Schools; Research; Research Personnel; Research Support; Role; Sampling; School Dentistry; Science; Scientist; Services; Source; System; Testing; Translational Research; Universities; acronyms; base; biobank; cancer diagnosis; cancer therapy; clinical investigation; college; cost; data management; innovation; medical schools; member; neoplasm immunotherapy; novel; pharmacokinetics and pharmacodynamics; phase 1 study; phase I trial; programs; quality assurance; structural biology; tumor immunology; virology

14.0 Abstract: Early Phase Clinical Research Support UMGCC investigator-initiated pilot (pre-Phase I) or Phase I trials that test clinical interventions with a candidate agent or device for the diagnosis, prevention, detection, or treatment of cancer frequently require funding to support research coordination, data management, and regulatory functions. Data from these trial protocols can be used to support later-phase activities with these interventions or as a basis for acquiring funding from other sources to continue the piloted activities. This critical early support provided by Early Phase Clinical Research Support (EPCRS) is necessary to move such trials forward, especially because per-patient costs are not reimbursed. EPCRS funds will be for UMGCC personnel, including research coordinators and data managers, to facilitate innovative clinical investigation efforts. Trials supported by EPCRS will be subject to additional criteria for consideration by the Clinical Research Committee either before their implementation and development or after needs emerge that are not addressed by other sponsoring agencies. The trials will be assigned a priority scale for funding based on how the protocol is significant and innovative in promoting the development of novel cancer diagnosis, treatment, imaging, or prevention strategies and based on evidence that the trial will enable correlative science as a result of EPCRS funding, with translational collaborators and assays in place. During the most recent 5-year funding period, 21 trials were developed by UMGCC investigators within the guidelines for funding through EPCRS. The narrative highlights five protocols recently launched or in development as examples of trials that will benefit from EPCRS in the future. These trials flow from investigator-initiated clinical research or are the logical consequence of an alliance between basic scientists at UMGCC and clinicians well suited to address a translational science goal and are either not incorporated into other grant-supported or Cooperative Group trials of NCI or other funding agencies or have only partial industry support.

14.0摘要：早期临床研究支持 UMGCC研究人员发起的试验(第一阶段前)或第一阶段试验，测试候选患者的临床干预措施 用于诊断、预防、检测或治疗癌症的试剂或设备经常需要资金 支持研究协调、数据管理和监管职能。来自这些试验方案的数据可以 用于通过这些干预措施支持后期活动，或作为从其他机构获得资金的基础 消息来源继续开展试点活动。这一关键的早期支持由早期临床研究提供 支持(EPCR)对于推进此类试验是必要的，特别是因为每个患者的成本不是 已经报销了。EPCRS资金将用于UMGCC人员，包括研究协调员和数据管理员， 以促进创新的临床研究工作。由EPCRS支持的试验将受到额外的 供临床研究委员会考虑的标准，在实施前和 发展或在出现其他赞助机构没有解决的需求之后。选拔赛将是 根据议定书在促进可持续发展方面的重要性和创新性，为供资分配了优先级别 开发新的癌症诊断、治疗、成像或预防策略并以证据为基础 该试验将使相关科学成为EPCRS资助的结果，并与翻译合作者和 化验已就位。在最近的5年资助期内，UMGCC开发了21项试验 调查人员在指导方针内通过EPCRS获得资金。这一叙述突出了最近的五项协议 已启动或正在开发中，作为今后受益于环境影响评估的试验的范例。这些试验流畅 来自研究人员发起的临床研究，还是基础研究联盟的合乎逻辑的结果 UMGCC的科学家和临床医生非常适合实现翻译科学目标，而不是 纳入NCI或其他资助机构的其他赠款支持或合作小组试验，或已 只有部分行业支持。