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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：
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
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/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&apos 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

项目摘要

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.

项目总结