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

项目摘要/摘要 我是一名获得董事会认证的女性放射肿瘤学家，也是加州大学圣地亚哥分校的教授， 在放射医学部。我的研究和临床工作涉及到妇科的各个阶段 (GYN)专注于翻译科学的临床试验，我是NRG肿瘤学NCI网络的领导者。 我在NRG肿瘤学领域的全国领导长达13年之久：我是放射科的核心成员 肿瘤学GOG委员会(2009-2015)，第一阶段开发治疗委员会，以及 宫颈癌委员会，这将导致服务作为妇科发展治疗的联合主席 2015-2018年委员会并接受NRG肿瘤学作为联合主席颁发的国家服务奖 2018年第一阶段委员会。然后，我从2018年到现在过渡到NRG宫颈癌联席主席。在……里面 这些角色，我通过写作制定了推进NCI临床试验的战略纲要，开发了新的 试验、积累，并及时向公众公布结果。我也热衷于 指导NRG的初级调查人员，以增加代表不足的多样性，因为调查人员 国家临床试验，并担任13项提案的首席研究员、主要导师或研究团队 自2018年以来一直在NRG担任GYN投资组合。在加州大学圣地亚哥分校，我深度参与了临床试验办公室，并 通过UCSD社区推广和参与提供的赠款，以增加NCI临床试验的公平性 招生。我是摩尔癌症中心(MCC)妇科疾病小组的联合组长 UCSD联合PI为ECTCN试验网络提供MCC的UM1 ETCTN赠款(VICKtOrY早期临床试验 联盟；UM1CA186689)，目标是将实验室发现带到患者和 改善未得到充分服务的人口的收益。我在Node开发了一系列早期临床试验 NCI资助的阳性高危宫颈癌，从2009年起担任GOG 9292“I期”的主要研究员 使用连续的ipilimumab治疗局部晚期宫颈癌的试验。并获得了NCI的职业发展 2018年临床试验获奖，作为GYN NRG 017的首席研究员，“抗PD-L1(Atezolizumab)作为 局部晚期淋巴结阳性的免疫底物联合扩大野放化疗 宫颈癌。“我的目标是扩大我们目前的努力，在整个 并通过临床试验开发、扩大我们的临床试验来确保公平获得这些药物 在少数族裔收入偏低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NCI资助的NRG肿瘤学新临床试验提交的PI和导师PI所做的努力 为全国和当地的妇产科患者建立网络；(2)确保在NRG内作为调查者的公平领导地位 肿瘤学临床试验，探索生物标记物驱动的临床试验翻译样本在分子上的公平性 测试；(3)在NRG肿瘤学小组中承担新的更高的领导角色。

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.