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.

项目摘要/摘要 我是女性认证的Radiotion肿瘤科医生和加利福尼亚大学圣地亚哥分校的教授， 在放射医学系。我的研究和临床工作涉及妇科的每个阶段 （GYN）临床试验的重点是转化科学，我是NRG肿瘤学NCI网络的领导者。 我在NRG肿瘤学中的国家领导层跨越了13年：我是辐射的核心成员 肿瘤学GOG委员会（2009- 2015年），I期发展治疗委员会和 宫颈癌委员会，该委员会成为GYN发育疗法的联合主席服务 2015 - 2018年委员会，并获得NRG肿瘤学的一项国民服务奖，作为主席 I阶段委员会于2018年。然后，我从2018年至今过渡到NRG宫颈癌联合主席。在 这些角色，我开发了推进NCI临床试验的战略大纲，开发了新的 及时的审判，振作和公众传播结果。我也很热衷于 NRG的初级研究人员的精神制度，以增加代表性不足的多样性作为研究者 国家临床试验，并担任首席研究员，主要导师或研究团队 自2018年以来，NRG的Gyn Portfolio。在UCSD上，我参与了临床试验办公室 通过UCSD社区宣传和参与赠款，以增加NCI临床试验中的股权 注册。我是摩尔癌中心（MCC）的GYN病小组的共同领导者， MCC的UM1 ETCTN Grant（Vicktory早期临床试验）的ECTCN试验网络的UCSD Co-PI 财团； UM1CA186689），目的是将实验室发现带给患者的治疗和 改善服务不足的人群的负担。我开发了一条在节点中的早期临床试验的管道 NCI资助正作为2009年的主要研究员的正面高风险宫颈癌，GOG 9292“ I期I期 在本地高级宫颈癌中使用顺序ipilimumab的试验。”并获得了NCI职业发展 2018年临床试验奖作为GYN NRG 017的首席研究员，“ Anti PD-L1（Atezolizumab）作为一个 免疫底漆，并同时与延长的场化学疗法，用于局部先进的节点阳性 我的目标是扩大我们目前的努力，以在整个过程中提供NCI资助的临床试验 区域，并通过临床试验开发确保与他们的公平访问权益，扩大我们的临床试验 代表人数不足的战略领域的办事处。有了R50奖，我将（1）扩展我的 当前作为NCI资助的NRG肿瘤学中新型临床试验提交的新型临床试验的PI和心理PI的努力 全国和本地妇科患者的网络； （2）确保股权领导力为NRG中的调查员地位 肿瘤学临床试验，并探索具有分子公平性的生物标志物驱动的临床试验翻译样品 测试； （3）在NRG肿瘤学小组中扮演新的和更高的领导角色。