Administrative supplement for Early Drug Development Opportunity Program (EDDOP)

早期药物开发机会计划 (EDDOP) 的行政补充

• 批准号: 10677500
• 负责人: Steven D Leach
• 金额: $ 7.5万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10677500
• 关键词: Address; Administrative Supplement; Antineoplastic Agents; Award; Basic Science; Cancer Biology; Cancer Center; Cancer Center Support Grant; Cancer Therapy Evaluation Program; Clinical; Clinical Cancer Center; Clinical Data; Clinical Protocols; Clinical Research; Clinical Treatment; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Collaborations; Component of the National Cancer Institute; Comprehensive Cancer Center; Conduct Clinical Trials; Development; Disease; Engineering; Evaluation; Funding; Funding Opportunities; Geographic Locations; Goals; Grant; Health; Image; Immunology; Infrastructure; Investigational Therapies; Laboratories; Lead; Leadership; Malignant Neoplasms; Mission; Monitor; Multi-Institutional Clinical Trial; National Cancer Institute; National Clinical Trials Network; New England; Participant; Patients; Peer Review; Phase; Positioning Attribute; Process; Protocols documentation; Rare Diseases; Request for Applications; Research; Research Personnel; Schools; Science; Services; Signal Transduction; Site; Testing; Therapeutic; Translational Research; Underserved Population; base; cancer imaging; cancer therapy; data management; drug development; early phase clinical trial; early phase trial; improved; improved outcome; innovation; interest; medical schools; meetings; member; multidisciplinary; patient population; phase III trial; programs; ranpirnase; rare cancer; response; rural underserved; targeted cancer therapy; treatment trial

ABSTRACT This proposal addresses Dartmouth Cancer Center’s (DCC) ability to conduct and participate in cancer early phase clinical trials through the Experimental Therapeutics Clinical Trials Network (ETCTN) of the National Cancer Institute (NCI). It serves as a comprehensive response to the NCI’s P30 Cancer Center Support Grant Administrative Supplement, to NCI-designated Cancer Centers previously participating in Create Access to Targeted Cancer Therapy for Underserved Populations (CATCH-UP), to promote continued collaboration with CTEP’s ETCTN under funding opportunity PA-20-272. DCC’s objectives as an NCI-designated comprehensive cancer center are aligned with ETCTN’s goals to conduct early phase clinical treatment trials across a broad range of cancers and diverse patient populations, with an emphasis on rare diseases. DCC was approved through peer review for the NCI Cancer Center’s Early Phase Clinical Research component of NCI Center Grants. Dartmouth is a Lead Academic Participating Site in the NCI National Clinical Trials Network. We currently are not affiliated with any ETCTN UM1 grantees that are funded to conduct studies of NCI-IND agents with a phase 1, and more recently also with phase 2, emphasis. Our proposal utilizes a pre-existing and functioning cadre of established inter- and multidisciplinary investigators at DCC, The Geisel School of Medicine at Dartmouth (Geisel), Dartmouth Health (DH), and the Thayer School of Engineering at Dartmouth, which share common clinical, basic science and clinical translational research interests in cancer treatment and imaging. We have core laboratories and an infrastructure that supports the conduct of a wide spectrum of correlative science studies typically associated with early phase trials and basic research in cancer biology, immunology, and imaging. As an academic NCI-designated comprehensive cancer center, we are well-positioned to provide scientific leadership in developing and conducting innovative early phase studies of anti-cancer agents held under CTEP’s IND, as well as substantial numbers of patients eligible for accrual to clinical trials conducted across the entire ETCTN.

抽象的 该提案涉及达特茅斯癌症中心（DCC）进行和参与的能力 通过实验疗法临床试验网络进行癌症早期临床试验 国家癌症研究所（NCI）（ETCTN）。它是对 NCI的P30癌症中心支持赠款的行政补充，以供NCI指定的癌症 以前参与创建目标癌症治疗的中心用于服务欠佳 人口（追赶），以促进与CTEP的ETCTN继续合作 资金机会PA-20-272。 DCC作为NCI指定的综合癌症的目标 中心与ETCTN的目标保持一致，以进行早期临床治疗试验 广泛的癌症和不同患者人群，重点是罕见疾病。 DCC通过NCI癌症中心早期临床的同行评审获得了批准 NCI中心补助金的研究组成部分。达特茅斯（Dartmouth）是主要的学术参与网站 在NCI国家临床试验网络中。我们目前不属于任何ETCTN UM1 资助以1阶段进行NCI-IND代理的研究的祖母，更多 最近也有第2阶段的重点。我们的建议利用了先前的和功能 DCC的DCC的既定学科和多学科研究人员的干部，Geisel学校 达特茅斯（Geisel），达特茅斯健康（DH）的医学和泰耶工程学院 在达特茅斯（Dartmouth），共享共同的临床，基础科学和临床翻译研究 对癌症治疗和成像的兴趣。我们有核心实验室和基础设施 支持通常与 早期试验和癌症生物学，免疫学和成像的基础研究。作为 学术NCI指定的综合癌症中心，我们有很好的位置 科学领导力在开发和进行反癌者的创新早期研究 在CTEP的IND下持有的代理商以及有资格获得准确性的大量患者 在整个ETCTN中进行的临床试验。