Administrative supplement for Early Drug Development Opportunity Program (EDDOP)

摘要 本提案涉及达特茅斯癌症中心（DCC）开展和参与以下活动的能力： 通过实验治疗药物临床试验网络进行癌症早期临床试验 （ETCTN）的国家癌症研究所（NCI）。它是对 NCI的P30癌症中心支持补助金行政补充，以NCI指定的癌症 曾参与为服务不足的人提供靶向癌症治疗的中心 人口（追赶），以促进与CTEP的ETCTN继续合作， 资助机会PA-20-272. DCC作为NCI指定的综合性癌症的目标 中心与ETCTN的目标保持一致，在一个 广泛的癌症和不同的患者人群，重点是罕见疾病。 DCC通过NCI癌症中心早期临床研究的同行评审获得批准 NCI中心赠款的研究部分。达特茅斯是一个领先的学术参与网站 NCI国家临床试验网络我们目前不隶属于任何ETCTN UM 1 受资助的受资助者进行NCI-IND药物的研究，1期，以及更多 最近也有第二阶段，重点。我们的建议利用了一个预先存在的和功能 在DCC建立跨学科和多学科的研究人员骨干，盖泽尔学院 医学在达特茅斯（Geisel），达特茅斯健康（DH），和工程的塞耶学院 在达特茅斯，它共享共同的临床，基础科学和临床转化研究 对癌症治疗和成像感兴趣。我们有核心实验室和基础设施， 支持进行广泛的相关科学研究，通常与 癌症生物学、免疫学和成像的早期试验和基础研究。作为 学术NCI指定的综合性癌症中心，我们有能力提供 在开发和开展创新性抗癌早期研究方面的科学领导力 根据CTEP的IND持有的药物，以及大量有资格累积的患者， 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.