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Administrative Supplement for VICKtOrY Early Clinical Trials Consortium

VICKtory 早期临床试验联盟的行政补充

基本信息

批准号：
10392078
负责人：
PATRICIA M. LORUSSO
金额：
$ 10万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-03-01 至 2022-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10392078
关键词：
Administrative Supplement Area Award Back Biological Markers California Cancer Center Cancer Patient Cancer Therapy Evaluation Program Clinic Clinical Clinical Research Clinical Trials Clinical Trials Network Collaborations Data Development Drug Delivery Systems Drug Kinetics Faculty Florida Funding Geography Goals Grant Infrastructure Institution Investigation Investigational Therapies Laboratories Lead Leadership Letters Malignant Neoplasms Mentors Mentorship Methods Minority Groups Mission Molecular Notification Oklahoma Patient Recruitments Patient Selection Patient-Focused Outcomes Patients Pharmacodynamics Pharmacopoeias Phase Philosophy Population Protocols documentation Reporting Research Research Design Research Personnel Resistance Rural Population Science Selection for Treatments Serum Services Site Special Population Therapeutic Toxic effect Training Translating Translational Research Translations Universities Variant Washington Work Yale Cancer Center biomarker-driven career clinical investigation cohesion cost design drug development early phase clinical trial early phase trial follow-up imaging biomarker improved outcome interest member next generation novel novel anticancer drug novel therapeutic intervention novel therapeutics patient biomarkers patient subsets rare cancer recruit resistance mechanism response student mentoring tissue biomarkers translational medicine treatment optimization trial design tumor

项目摘要

ABSTRACT: This application is being submitted to request additional funds for three Affiliated Organizations (AOs) to an NCI Experimental Therapeutics-Clinical Trials Network (ETCTN) UM1 Lead Academic Organization. The purpose of the ETCTN is to develop new therapeutic options while also defining better approaches for the development of novel anticancer agents that capitalize on the ability to characterize tumors molecularly. As biomarker-driven trials become the cornerstone of early phase investigation, allowing for the study of potential mechanisms of response and resistance, incorporation of these biomarkers is lending itself to novel trial designs which incorporate fewer, and often rarer patient subsets, defining greater patient outcomes with smaller recruited populations. As a result, a unique network such as the ETCTN, consisting of multiple scientifically-driven sites and investigators with a vast array of expertise, is needed. In 2020, we were awarded a UM1 grant (2UM1CA186689) which was a re-competition of a previous ETCTN UM1 award, demonstrating both our progress over the past funding period as well as our capabilities to conduct early phase clinical trials. In response to a notification from the NCI Cancer Therapy Evaluation Program (CTEP), we are submitting this administrative supplement to offset some of the costs of absorbing three additional AOs leading active ETCTN clinical trials but which were not included in our original funded ETCTN UM1 Type 2 award. These centers were added to our consortium in the interest of providing continuity for productive ETCTN sites leading active trials (those with patients on ETCTN trials in treatment and in follow-up). Our original partnerships included Vanderbilt-Ingram, University of California San Diego, University of Oklahoma Stephenson Cancer Center and the Yale Cancer Center (VICtOrY). We have added Columbia University, Washington University in St. Louis, and the University of Florida to this consortium to form VICtOrY-CWF. Our team aims to 1) leverage novel scientific discoveries for translation into early phase trials, using the CTEP pharmacopeia, in rare cancers, common cancers, and uncommon variants of common cancers; 2) incorporate serum, tissue and imaging biomarkers to better understand the effects of novel agents either alone or in combination; 3) train early career investigators to be knowledgeable and proficient in conducting early phase clinical trials by providing clinical research leadership opportunities and mentoring; and 4) include as a component of our early phase clinical trial recruitment, no less than 10% underserved/special populations. The members of our team, along with the proposed additional sites, have a unique set of complementary expertise and a similar philosophy regarding collaborative research and mentorship of the next generation of cancer investigators. Together, VICtOrY-CWF is committed to utilizing our areas of expertise, integrating the science at our institutions, and maximizing our collaborative relationships to conduct cutting-edge early phase trials within the ETCTN with the ultimate mission of improving outcomes for cancer patients.

摘要：本申请为三个附属机构申请额外资金