Administrative supplement for Early Drug Development Opportunity Program (EDDOP)

摘要 该提案涉及达特茅斯癌症中心(DCC)开展和参与 通过实验治疗学临床试验网络进行癌症早期临床试验 美国国家癌症研究所(NCI)的。它是对 NCI的P30癌症中心对NCI指定的癌症的资助行政补助金 以前参与的中心为未得到充分服务的人创造获得靶向癌症治疗的机会 人口(追赶)，以促进继续与CTEP的ETCTN合作 融资机会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，即在 广泛的癌症和不同的患者群体，重点是罕见疾病。 DCC通过同行评审，用于NCI癌症中心的早期临床 NCI中心拨款的研究部分。达特茅斯大学是领先的学术参与网站。 在NCI国家临床试验网络中。我们目前没有与任何ETCTN UM1有关联 被资助进行NCI-IND药物研究的受赠者，阶段1，以及更多 最近还与第二阶段，重点。我们的建议利用了一个预先存在的和正在运行的 在DCC，盖泽尔学院的资深跨学科和多学科调查人员 达特茅斯(盖泽尔)、达特茅斯健康(卫生)和塞耶工程学院的医学 在达特茅斯，分享共同的临床、基础科学和临床转化研究 对癌症治疗和成像感兴趣。我们拥有核心实验室和基础设施， 支持开展广泛的相关科学研究，这些研究通常与 癌症生物学、免疫学和成像领域的早期试验和基础研究。作为一种 学术NCI指定的综合性癌症中心，我们有能力提供 在开发和开展抗癌早期创新研究方面的科学领导 根据CTEP的IND持有的代理，以及有资格获得应计费用的大量患者 在整个ETCTN进行的临床试验。

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.