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 在健康成年人中，父母的研究，Xanthhohumol微生物组和签名（XMA），是RO1资助的多个 主要研究人员主导的FDA批准的1阶段临床试验旨在确定安全性和耐受性 由叶thohumol（Xn）制成的天然产物，该化合物在humulus lupulus（hops）中，健康 成年人。除了评估安全外，俄勒冈州立大学试验的合作者还将产生 XN代谢产物及其对炎症和肠道完整性生物标志物的影响。此外，合作者 在太平洋西北国家实验室将通过 测序和代谢组学分析。总的来说，这些数据将用作一个比较数据 随后在克罗恩病成年人的成年人进行的2期临床试验。家长项目正在积极招聘， 注册参与者，并将在整个2020年中这样做。 补充剂将为博士后，早期培训提供独特的培训机会，并 综合健康（CIH）临床：1。通过参与进行临床试验的提供者经验 在经验丰富的领导和心态下，在积极临床试验的运营方面 研究人员团队； 2。支持转化科学方法的独特曝光和说明 多PI团队实验室中使用的技术；和3。鼓励生物统计学的技能发展， 演示和出版。试验参与将通过在临床筛查中培训候选人来启动 以及其他访问，包括：调查数据和生物标本的收集以及不良事件报告， 在试验方案中概述。候选人还将获得试验中包括的特定测定法 作为微生物群测序和代谢组分析，通过每种旋转的动手体验 协作实验室。最后，生物统计学，演示和未来出版的技能发展将是 通过在系统评价，生物统计学课程中进行培训，进行辅助分析 预先存在数据并参加系统的审查写作团队。虽然参与的第一年是 预计将在这些目标方面产生可衡量的进展，第二年的支持将使 将培训扩展到父母研究的其他阶段。