Interventional oncology clinical research specialist

介入肿瘤学临床研究专家

• 批准号: 10569146
• 负责人: MICHAEL C SOULEN
• 金额: $ 17.31万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10569146
• 关键词: Ablation; Address; Area; Autophagocytosis; Cancer Center; Cancer Patient; Caring; Chemosensitization; Clinical Investigator; Clinical Oncology; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Discipline; Educational process of instructing; Event; Failure; Fostering; Free Radicals; Generations; Immunologic Adjuvants; Injections; Institution; Intervention; Investigation; Ischemia; Malignant Neoplasms; Medical Oncology; Oncologist; Oncology; Operative Surgical Procedures; Outcome; Physicians; Process; Radiation; Radiation Oncology; Radiation-Sensitizing Agents; Research Personnel; Role; Solid Neoplasm; Specialist; Surgical Oncology; Therapeutic Agents; Therapeutic Embolization; Time; Toxic effect; Vaccines; cancer care; checkpoint inhibition; chemotherapy; chimeric antigen receptor T cells; clinical trial protocol; image guided; image guided therapy; improved; interdisciplinary collaboration; internal radiation; medical specialties; minimally invasive; multidisciplinary; nano; novel; novel therapeutics; recruit; synergism; trial design

Interventional Oncology (IO) is emerging as the fourth pillar of cancer care alongside medical, radiation, and surgical oncology. Interventional oncologists provide minimally invasive image-guided therapies to treat cancers without the toxicities and disfigurement of chemotherapy, radiation or surgery. New clinical trial designs and collaborations are essential to determine how and when IO therapies should be integrated into multidisciplinary care plans to achieve optimal outcomes for cancer patients. Obstacles to this are many. Trial designs must accommodate staged and repeatable therapies, which complicates time-to-event analysis. There is a dearth of interventional oncology clinical investigators, who are needed to build collaborations with other oncologic disciplines to develop new concepts and protocols for clinical trials. The NCI cooperative group hierarchy is the domain of medical oncology. Surgical and interventional concepts struggle to hurdle the many layers of the review process, which is a barrier to the recruitment and retention of young investigators. Less than 5% of the >100 NCTN trials open at the applicant’s cancer center involve more than one cancer specialty, a stark indicator of the deficit in interdisciplinary clinical research. Conducting interdisciplinary trials is fraught with logistical and administrative challenges when the treating physicians practice in different departments, which historically is a major determinant of trial failure. The role of a senior IO clinical research specialist is to address each of these obstacles at the institutional and NCTN level. This starts with teaching clinical trial design and execution to a new cadre of young investigators from all cancer disciplines. Interdisciplinary collaborations can then be created within and across NCTN institutions to generate new trial concepts investigating the intersection of systemic and image-guided therapies to create new therapeutic synergies. Areas ripe for investigation include potentiation of ischemia by targeting HIF activation, autophagy, and free radical generation; potentiation of selective internal radiation with radiosensitizers; potentiation of thermal-based therapies to improve ablation margins; ablation and embolization as immunostimulants to potentiate immune checkpoint inhibition; image-guided delivery of CAR-T cells into solid tumors; direct injection and intralymphatic administration of vaccine-based agents; and nanoconstructs for delivery of therapeutic agents. These novel concepts need to be guided through the labyrinthian NCTN process, and new platforms developed for execution of interdepartmental clinical trials.

介入肿瘤学 (IO) 正在成为癌症治疗的第四大支柱 医学、放射学和肿瘤外科。介入肿瘤科医生提供微创治疗 图像引导疗法治疗癌症，没有化疗的毒性和毁容， 放射或手术。新的临床试验设计和合作对于确定如何进行至关重要 何时应将 IO 疗法纳入多学科护理计划以达到最佳效果 癌症患者的结果。这方面的障碍有很多。试验设计必须适应 分阶段和可重复的治疗，这使得事件时间分析变得复杂。缺乏 介入肿瘤学临床研究人员，需要与其他人建立合作 肿瘤学科开发新的临床试验概念和方案。美国国家癌症研究所 合作小组层次结构是肿瘤医学领域。手术和介入 概念很难跨越审查过程的多层，这是阻碍 招募和保留年轻研究者。在超过 100 项 NCTN 试验中，只有不到 5% 的试验在 申请人的癌症中心涉及多个癌症专科，这是一个明显的指标 缺乏跨学科临床研究。进行跨学科试验充满了 当治疗医生在不同的领域执业时，后勤和行政方面的挑战 部门，这在历史上是审判失败的一个主要决定因素。 高级 IO 临床研究专家的作用是解决这些障碍 机构和 NCTN 层面。首先向患者教授临床试验设计和执行 来自所有癌症学科的年轻研究人员的新骨干。跨学科合作可以 然后在 NCTN 机构内部和跨机构创建，以产生新的试验概念调查 系统治疗和图像引导治疗的交叉，创造新的治疗协同作用。 成熟的研究领域包括通过靶向 HIF 激活来增强缺血， 自噬和自由基产生；选择性内辐射的增强 放射增敏剂；增强热疗法以改善消融裕度；消融 和栓塞作为免疫刺激剂以增强免疫检查点抑制；图像引导 将 CAR-T 细胞递送至实体瘤；直接注射和淋巴内给药 疫苗制剂；和用于递送治疗剂的纳米结构。这些小说 概念需要通过迷宫般的 NCTN 流程和新平台来引导 为执行跨部门临床试验而开发。