CIH Practitioner Mentorship in Translational Clinical Research

CIH 转化临床研究从业者指导

• 批准号: 10273070
• 负责人: Ryan D Bradley
• 金额: $ 9.51万
• 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/10273070
• 关键词: Administrative Supplement; Adult; Adverse event; Alternative Medicine; Analytical Chemistry; Award; Biological; Biological Assay; Biological Markers; Biometry; Blood; COVID-19; Clinical; Clinical Research; Clinical Trials; Collaborations; Collection; Complementary Health; Complementary Medicine; Conduct Clinical Trials; Controlled Clinical Trials; Coupled; Crohn' s disease; Data; Data Analyses; Development; Doctor of Philosophy; Enrollment; Epidemiology; Exposure to; FDA approved; First Year Experience; Funding; Future; Grant; Health Promotion; Humulus; Immersion; Individual; Inflammation; Institutional Review Boards; Instruction; Integrative Medicine; Interview; Intestinal permeability; Investments; Laboratories; Leadership; Manuscripts; Measurement; Measures; Medical; Medicine; Mentorship; Metabolism; Methodology; Methods; Natural Products; Oregon; Pacific Northwest; Parents; Participant; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Placebos; Population; Postdoctoral Fellow; Principal Investigator; Process; Protocols documentation; Publications; Publishing; Reporting; Research; Research Personnel; Research Training; Rotation; Safety; Site; Specimen; Statistical Data Interpretation; Structure; Surveys; Techniques; TimeLine; Training; Translational Research; United States; United States National Institutes of Health; Universities; Urine; Visit; Writing; blind; career; career development; clinical toxicology; coronavirus disease; experience; follow-up; inflammatory disease of the intestine; innovation; interest; meetings; member; metabolomics; microbiome signature; microbiota; operation; patient population; phase I trial; phase II trial; recruit; response; screening; skill acquisition; skills; skills training; stool sample; success; systematic review; technical writing; training opportunity

Project Summary The parent study, Xanthohumol Microbiome and Signature (XMaS), is a RO1-funded, multiple principal investigator-led, FDA-approved clinical trial that completed its Phase 1 clinical operation earlier this year. The Phase 1 trial aimed 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, and 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 the Phase 2 clinical trial in Crohn’s Disease, which began recruitment on September 16th, 2020. The additional support of a second-year administrative supplement for Dr. Langley will allow for continued training opportunity for a post-doctoral, early-career Complementary and Integrative Health (CIH) clinician by: 1. Building upon 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. Gaining exposure and instruction on the translational scientific methods and techniques used in the collaborative laboratories of the multi-PI team; 3. Encouraging skill development in technical writing, presentation, publication, and statistical analysis; and 4. Developing skills in biostatistics, epidemiology, and clinical trial methodology through didactic coursework. 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 by finalizing the scoping review currently in development, biostatistics and epidemiology coursework, continuing manuscript development, and performing secondary data analysis under the mentorship of our resident biostatistician. With the successful completion of his initial year of training, a second year of support for Dr. Langley will provide valuable experience as he becomes more competitive for future training awards in clinical and translational research.

项目概要 父研究“黄腐酚微生物组和特征 (XMaS)”是一项由 RO1 资助的多主体研究 由研究者主导、 FDA 批准的临床试验于今年早些时候完成了 1 期临床操作。这 第一阶段试验旨在确定由黄腐酚 (XN) 制成的天然产品的安全性和耐受性，黄腐酚是一种 在健康成年人的啤酒花（啤酒花）中发现的化合物。除了评估安全性之外，合作者还 俄勒冈州立大学的试验还将生成 XN 代谢物及其对生物标志物影响的数据 炎症和肠道完整性，太平洋西北国家实验室的合作者将确定 通过测序和代谢组学分析 XN 对微生物群的影响。总的来说，这些数据将 用作克罗恩病 2 期临床试验的比较数据，该试验于 9 月开始招募 2020 年 16 日。兰利博士第二年行政补充的额外支持将允许 博士后、职业早期补充和综合健康 (CIH) 的继续培训机会 临床医生： 1. 通过参与运营，积累进行临床试验的经验 在经验丰富的团队的领导和指导下进行积极的临床试验的各个方面 研究人员； 2. 获得有关转化科学方法和技术的接触和指导 多PI团队的协作实验室； 3. 鼓励技术写作技能的发展， 演示、出版和统计分析； 4. 培养生物统计学、流行病学和 通过教学课程学习临床试验方法。试用参与将通过培训候选人来启动 在临床筛查和其他访问中，包括：收集调查数据和生物样本，以及不良反应 事件报告，如试验方案中所述。候选人还将接触到特定的检测，包括 在试验中，通过轮换的实践经验，例如微生物群测序和代谢组学分析 在每个合作实验室。最后，生物统计学、演示和未来出版方面的技能发展将是 通过完成目前正在开发的范围界定审查、生物统计学和流行病学课程作业来进行， 继续手稿开发，并在我们的指导下进行二次数据分析 常驻生物统计学家。成功完成第一年的培训后，第二年的支持 兰利博士将提供宝贵的经验，因为他在未来的临床培训奖项中更具竞争力 和转化研究。