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.

项目总结/摘要 我是一名女性委员会认证的放射肿瘤学家和教授，在加州大学（UC），圣地亚哥， 在放射医学部。我的研究和临床工作涉及妇科的每一个阶段， (GYN)临床试验，重点是转化科学，我是NRG肿瘤NCI网络的领导者。 我在NRG肿瘤学的国家领导跨越了13年：我曾担任辐射的核心成员， 肿瘤GOG委员会（2009-2015）、I期开发治疗委员会和 宫颈癌委员会，导致服务作为共同主席的妇科发展治疗 委员会2015-2018年，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年至今过渡到NRG宫颈癌联合主席。在 这些角色，我制定了推进NCI临床试验的战略纲要，通过写作，开发新的 试验、累积和及时公布结果。我也积极参与了 指导NRG的初级调查员，以增加代表性不足的多样性， 国家临床试验，并担任主要研究者，主要导师，或研究团队的13个建议， 自2018年以来，NRG的GYN组合。在UCSD，我积极参与临床试验办公室的工作， 通过UCSD社区外展和参与提供赠款，以增加NCI临床试验之间的公平性 招生我是摩尔斯癌症中心（MCC）妇科疾病团队的联合负责人， UCSD Co-PI for the ECTCN trial network on MCC's UM1 ETCTN grant（VICKtOrY Early Clinical Trials Consortium; UM 1CA 186689），目标是将实验室发现用于患者治疗， 改善服务不足人口的增加。我在Node开发了一系列早期临床试验 从2009年起，作为GOG 9292“I期”的主要研究者，由NCI资助， 在局部晚期宫颈癌中使用依匹单抗的试验。”并获得了NCI职业发展 作为GYN NRG 017的主要研究者，2018年获得临床试验奖，“抗PD-L1（Atezolizumab）作为一种 免疫引物联合扩大野放化疗治疗局部晚期淋巴结阳性 宫颈癌。”我的目标是扩大我们目前的努力，在整个国家提供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， 在少数族裔应计权益不足的战略领域设立办事处。有了R50奖，我将（1）扩大我的 目前作为PI和导师PI在NCI资助的NRG肿瘤学中提交新临床试验的工作 全国和地方妇科患者网络;（2）确保NRG内作为研究者地位的平等领导 肿瘤学临床试验，并探索生物标志物驱动的临床试验转化样本，在分子水平上具有公平性 测试;（3）在NRG肿瘤组中担任新的更高的领导角色。