CIH Practitioner Mentorship in Translational Clinical Research

CIH 转化临床研究从业者指导

• 批准号: 10027107
• 负责人: Ryan D Bradley
• 金额: $ 13.96万
• 依托单位: OREGON STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-21 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10027107
• 关键词: Administrative Supplement; Adult; Adverse event; Analytical Chemistry; Award; Biological; Biological Assay; Biological Markers; Biometry; Blood; Clinical; Clinical Research; Clinical Trials; Collaborations; Collection; Complementary Health; Complementary therapies; Conduct Clinical Trials; Controlled Clinical Trials; Coupled; Crohn' s disease; Data; Doctor of Philosophy; Enrollment; Ensure; Exposure to; FDA approved; Feces; Funding; Future; Human; Humulus; Immersion; Individual; Inflammation; Institutional Review Boards; Instruction; Integrative Medicine; Intestinal permeability; Investigational New Drug Application; Investments; Knowledge; Laboratories; Leadership; Learning; Lymphocyte; Manuscripts; Measurable; Measurement; Measures; Medical; Medicine; Mentorship; Metabolism; Methods; Natural Products; Oregon; Pacific Northwest; Paper; Parents; Participant; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Placebos; Population; Postdoctoral Fellow; Principal Investigator; Process; Protocols documentation; Public Health; Publications; Randomized; Recommendation; Recruitment Activity; Reporting; Research; Research Personnel; Research Training; Review Literature; Rotation; Safety; Specimen; Surveys; Techniques; Telephone; Time; TimeLine; Training; Translational Research; United States; United States National Institutes of Health; Universities; Urine; Visit; Writing; blind; career; career development; clinical toxicology; comparison group; expectation; experience; healthy volunteer; inflammatory disease of the intestine; innovation; interest; meetings; member; metabolomics; microbiome; microbiota; neutrophil; novel; operation; parent project; phase I trial; phase II trial; recruit; response; screening; skill acquisition; skills; skills training; success; systematic review; training opportunity

Project Summary The parent study, Xanthohumol Microbiome and Signature (XMaS) in Healthy Adults, is a RO1-funded, multiple principal investigator-led, FDA-approved Phase 1 clinical trial which aims to determine the safety and tolerability of a natural product made from xanthohumol (XN), a compound found in Humulus lupulus (hops), in healthy adults. In addition to assessing safety, collaborators on the trial from Oregon State University will also generate data on XN metabolites and its effects on biomarkers of inflammation and gut integrity. Additionally, collaborators at the Pacific Northwest National Laboratory will determine the effects of XN on the microbiota through sequencing and metabolomics profiling. Collectively, these data will be used as comparison data for a subsequent Phase 2 clinical trial in adults with Crohn’s Disease. The parent project is actively recruiting and enrolling participants, and will be doing so throughout 2020. The additional support of an administrative supplement will allow for a unique training opportunity for a post-doctoral, early-career Complementary and Integrative Health (CIH) clinician by: 1. Providing experience in the conduct of clinical trials through participation in the operational aspects of an active clinical trial while under the leadership and mentorship of an experienced team of researchers; 2. Supporting unique exposure and instruction on the translational scientific methods and techniques used in the laboratories of the multi-PI team; and 3. Encouraging skill development in biostatistics, presentation and publication. Trial participation will be initiated by training the candidate in clinical screenings and other visits, including: collection of survey data and biologic specimens, and adverse event reporting, as outlined in the trial protocol. The candidate will also gain exposure to specific assays included in the trial, such as microbiota sequencing and metabolomic profiling, through hands-on experience with rotations in each collaborative lab. Finally, skills development in biostatistics, presentation, and future publication will be conducted through training in systematic reviews, biostatistics coursework, performing an ancillary analysis of pre-existing data and participating in a systematic review writing team. While an initial year of participation is expected to produce measurable progress toward these aims, a second year of support would enable an extension of training into additional stages of the parent study.

项目摘要 父母研究，黄腐酚微生物组和签名(XMAS)在健康成年人中，是一项由RO1资助的多项 首席研究员领导，FDA批准的1期临床试验，旨在确定安全性和耐受性 一种由黄腐酚(XN)制成的天然产品，黄腐酚是一种在啤酒花中发现的化合物，在健康人群中 成年人。除了评估安全性外，俄勒冈州立大学的试验合作者还将产生 有关XN代谢物及其对炎症和肠道完整性生物标志物的影响的数据。此外，合作者 太平洋西北国家实验室将通过以下途径确定XN对微生物区系的影响 测序和代谢组学分析。总的来说，这些数据将用作 随后在成人克罗恩病患者中进行的第二阶段临床试验。母项目正在积极招聘和 招募参与者，并将在整个2020年这样做。行政部门的额外支持 补充将为博士后、职业生涯早期补充和 综合健康(CIH)临床医生：1.通过参与提供进行临床试验的经验 在有经验的专家的领导和指导下进行积极的临床试验的操作方面 研究人员团队；2.支持对翻译科学方法和 多PI小组实验室中使用的技术；以及3.鼓励生物统计方面的技能发展， 演示文稿和出版。参加试验将通过对候选人进行临床筛查培训来启动 和其他访问，包括：收集调查数据和生物标本，以及不良事件报告，如 在试验方案中概述。候选人还将接触到试验中包括的特定化验，如 作为微生物区系测序和代谢组谱分析，通过在每个轮换中的实践经验 协作实验室。最后，生物统计、演讲和未来出版方面的技能发展将是 通过系统审查、生物统计学课程工作的培训进行，执行对 预先存在的数据，并参加一个系统的综述写作团队。虽然参加的最初一年是 预计将在实现这些目标方面取得可衡量的进展，第二年的支持将使 将培训扩展到家长研究的其他阶段。