CIH Practitioner Mentorship in Translational Clinical Research

CIH 转化临床研究从业者指导

基本信息

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
项目类别：
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&apos 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

项目摘要

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.

项目摘要父母研究，xanthhohumol微生物组和签名（XMA），是RO1资助的多个主体研究人员主导的FDA批准的临床试验于今年早些时候完成了其1期临床操作。这 1阶段试验旨在确定由Xanthohumol（XN）制成的天然产物的安全性和耐受性在健康成年人中发现了在Humulus lupulus（Hops）中发现的化合物。除了评估安全外，合作者还俄勒冈州立大学的试验还将生成有关XN代谢产物及其对生物标志物的影响的数据炎症和肠道完整性以及太平洋西北国家实验室的合作者将确定 XN通过测序和代谢组学分析对微生物群的影响。总的来说，这些数据将是用作克罗恩病第二阶段临床试验的比较数据，该试验于9月开始招募 2020年16日。兰利博士二年级行政补充的额外支持将允许继续进行博士后，早期护理和综合健康（CIH）的培训机会临床作者：1。基于通过参与临床试验的经验而建立的经验在经验丰富的团队的领导和心态下，主动临床试验的各个方面研究人员； 2。获得有关使用的翻译科学方法和技术的说明 Multi-Pi团队的合作实验室； 3。鼓励技术写作的技能发展，演示，出版和统计分析； 4。发展生物统计学，流行病学和临床试验方法通过教学课程。审判参与将通过培训候选人来发起在临床筛查和其他访问中，包括：调查数据和生物标本的收集以及逆境事件报告，如试验协议中概述。候选人还将获得包括特定测定法在试验中，通过旋转的动手经验，例如微生物群测序和代谢组分析在每个协作实验室中。最后，生物统计学，演示和未来出版的技能发展将是通过确定目前开发，生物统计学和流行病学课程的范围审查来进行的，继续手稿开发，并在我们的指导下进行次要数据分析居民生物统计学家。随着他最初的培训的成功完成，第二年的支持兰利博士将提供宝贵的经验，因为他在临床上变得更加竞争力并翻译研究。