NCI Clinical Trial Research Strategy, Harnessing of Equity, and Implementation

NCI 临床试验研究策略、公平利用和实施

• 批准号: 10721134
• 负责人: Jyoti Mayadev
• 金额: $ 17.39万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-04 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10721134
• 关键词: Area; Award; Board Certification; California; Cancer Center; Cervix Uteri; Clinical; Clinical Trials; Committee Members; Community Outreach; Development; Developmental Therapeutics Program; Early Therapeutic-Clinical Trials Network; Ensure; Equity; Female; Female Genital Diseases; Funding; Goals; Grant; Gynecologic; Gynecologic Oncology Group; Immune; Information Dissemination; Institution; K-Series Research Career Programs; Leadership; Malignant neoplasm of cervix uteri; Medicine; Mentors; Mentorship; Molecular; Oncology; Oncology Group; Outcome; Patients; Phase; Positive Lymph Node; Principal Investigator; Qualifying; Radiation; Radiation Oncologist; Radiation Oncology; Rebecca and John Moores UCSD Cancer Center; Research; Research Personnel; Role; Sampling; Services; Testing; Therapeutic; Therapeutics Committee; Translational Research; Underrepresented Minority; Underserved Population; Universities; Writing; anti-PD-L1; biomarker driven; cancer clinical trial; chemoradiation; clinical trial enrollment; community engagement; early phase clinical trial; health care disparity; high risk; improved; ipilimumab; member; novel; phase I trial; professor; programs; translational clinical trial; treatment trial

PROJECT SUMMARY/ABSTRACT I am a female board-certified radiation oncologist and Professor at the University of California (UC), San Diego, in the Department of Radiation Medicine. My research and clinical efforts involve every phase of gynecologic (GYN) clinical trials with a focus on translational science, and I am a leader in the NRG Oncology NCI network. My national leadership within NRG Oncology spans over 13 years: I served as a core Member of the Radiation Oncology GOG committee (2009–2015), the Phase I Developmental Therapeutics Committee, and the Cervical Cancer Committee, which lead to service as Co-Chair of the GYN Developmental Therapeutics Committee 2015–2018 and receipt of a National Service Award from NRG Oncology as the Co-Chair of the Phase I Committee in 2018. I then transitioned to the NRG cervical cancer co-chair from 2018-present. In these roles, I develop the strategic outline of advancing NCI clinical trials though writing, development of new trials, accrual, and public dissemination of the results in a timely fashion. I am also keenly involved with the mentorship of junior investigators at the NRG to increase underrepresented diversity as investigators on national clinical trials and serve as the principal investigator, primary mentor, or study team on 13 proposals in the GYN portfolio at NRG since 2018. At UCSD, I am heavily involved with the clinical trials office and have grants through the UCSD community outreach and engagement to increase equity among NCI clinical trial enrollment. I serve as the Co-Leader of the GYN Disease Team at the Moores Cancer Center (MCC), the UCSD Co-PI for the ECTCN trial network on MCC’s UM1 ETCTN grant (VICKtOrY Early Clinical Trials Consortium; UM1CA186689), with the goal of bringing lab discoveries to the treatment of patients and improving accrual of underserved populations. I developed a pipeline of early phase clinical trials in node positive high risk cervical cancer with NCI funding as principal investigator from 2009 for GOG 9292 “Phase I trial using sequential ipilimumab in locally advanced cervical cancer.” and received a NCI career development award for the clinical trial in 2018 as principal investigator on GYN NRG 017, “Anti PD-L1 (Atezolizumab) as an immune primer and concurrently with extended field chemoradiotherapy for node positive locally advanced cervical cancer.” My goal is to expand our current efforts to offer NCI-funded clinical trials throughout the region, and ensure equity access to them through clinical trial development, expansion of our clinical trials office in strategic areas of underrepresented minority accrual. With the R50 Award, I would (1) expand my current efforts as a PI and mentor PI for novel clinical trial submissions in the NCI funded NRG Oncology network for GYN patients nationally and locally; (2) ensure equity leadership as investigator status within NRG Oncology clinical trials, and explore biomarker-driven clinical trial translational samples with equity in molecular testing; (3) take on new and higher leadership roles within the NRG oncology group.

项目概要/摘要 我是一名女性委员会认证的放射肿瘤学家，也是圣地亚哥加利福尼亚大学 (UC) 的教授， 在放射医学系。我的研究和临床工作涉及妇科的各个阶段 （妇科）临床试验，重点关注转化科学，我是 NRG 肿瘤学 NCI 网络的领导者。 我在 NRG 肿瘤学领域的国家领导地位已超过 13 年：我曾担任放射中心的核心成员 肿瘤学 GOG 委员会（2009-2015）、第一阶段发展治疗委员会和 宫颈癌委员会，担任妇科发展治疗学联合主席 委员会 2015-2018 并作为联合主席获得 NRG 肿瘤学国家服务奖 2018 年第一阶段委员会。然后，我从 2018 年至今转任 NRG 宫颈癌联合主席。在 这些角色，我通过写作、开发新药物来制定推进 NCI 临床试验的战略大纲 并及时向社会公布试验结果。我也热衷于参与 对 NRG 的初级调查员进行指导，以增加调查员代表性不足的多样性 担任国家级临床试验项目的主要研究者、主要导师或研究团队13项 自 2018 年以来，我在 NRG 担任 GYN 项目组合。在 UCSD，我积极参与临床试验办公室的工作，并 通过 UCSD 社区外展和参与提供资助，以提高 NCI 临床试验的公平性 注册。我担任摩尔斯癌症中心 (MCC) 妇科疾病团队的联合领导者， UCSD 的 ECTCN 试验网络联合 PI，获得 MCC 的 UM1 ETCTN 资助（VICKtOrY 早期临床试验 财团； UM1CA186689），目标是将实验室发现应用于患者的治疗和 提高服务不足人群的收益。我在 Node 中开发了一系列早期临床试验 阳性高危宫颈癌，自 2009 年起由 NCI 资助作为 GOG 9292“第一阶段”的首席研究员 使用序贯伊匹单抗治疗局部晚期宫颈癌的试验。”并获得 NCI 职业发展 2018 年作为 GYN NRG 017 的主要研究者获得临床试验奖，“抗 PD-L1（Atezolizumab）作为一种 免疫引物并同时联合大范围放化疗治疗淋巴结阳性局部晚期 宫颈癌。”我的目标是扩大我们目前的努力，在整个国家/地区提供 NCI 资助的临床试验 地区，并通过临床试验开发、扩大我们的临床试验确保公平地获得它们 代表不足的少数族裔应计战略领域的办公室。凭借 R50 奖，我将 (1) 扩展我的 目前作为 PI 和导师 PI 在 NCI 资助的 NRG 肿瘤学中提交新的临床试验 全国和地方妇科患者网络； (2) 确保 NRG 内作为研究者的平等领导地位 肿瘤学临床试验，探索具有分子公平性的生物标志物驱动的临床试验转化样本 测试； (3) 在 NRG 肿瘤学小组中担任新的更高领导角色。