GENETIC SUSCEPTIBILITY AND ENVIRONMENTAL FACTORS

遗传易感性和环境因素

基本信息

批准号：
8151590
负责人：
RICHARD COHN
金额：
$ 565.38万
依托单位：
CONSTELLA GROUP, LLC
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-09-30 至 2011-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8151590
关键词：
Adverse effects Biochemical Biological Biological Products Blood Chemicals Clinical Clinical Research Clinical Trials Complex Conduct Clinical Trials Consent Forms Contract Services Contracts Data Data Collection Databases Development Diagnosis Diagnostic Procedure Diet Disease Electronics Environmental Exposure Environmental Risk Factor Genetic Genetic Predisposition to Disease Goals Health Insurance Portability and Accountability Act Human Human Resources Intervention Interview Intramural Research Laboratories Life Style Minerals Molecular Monitor National Institute of Environmental Health Sciences Operative Surgical Procedures Outpatients Pamphlets Patient Care Patients Pharmaceutical Preparations Phase Population Preventive Intervention Principal Investigator Private Sector Procedures Protocols documentation Quality Control Questionnaires Radiation Records Recruitment Activity Research Ethics Committees Sampling Shipping Ships Site Specimen Study Subject Support Contracts Techniques Testing Therapeutic Uses Training Support Translations Update Urine Validation Vitamins Work abstracting base case history design dietary supplements experience human disease human tissue instrument programs research clinical testing research study trait

项目摘要

The Clinical Research Program at the NIEHS conducts or oversees clinical research studies within the Division of Intramural Research. The objectives of these studies are to: 1) investigate the interaction between genetic susceptibility and environmental factors as related to complex traits and diseases in human populations; and 2) intervene in disease development or progression by reducing genetic and environmental risk factors using therapeutic, surgical or radiation techniques, or by altering environmental exposures, diet and lifestyles. This contract will provide all types of support to principal investigators (PIs) in the OCR and DIR needed to conduct both observational clinical research studies and interventional clinical trials. Although clinical research has been ongoing within the DIR, it has been severely limited by the number of personnel in the CRP, the lack of support personnel required to carry out the various tasks, and lack of already established mechanisms for patient care and conducting clinical trials. Furthermore, conducting clinical research studies by DIR staff in various localities, especially for smaller studies, can be costly, difficult, or simply not feasible. Private sector efforts now exist with access to national networks of personnel with experience in many phases of such work, and could more effectively provide such support. Especially for small projects, a single team of support personnel under a central management concept would be more efficient, provide more continuity, and be more subject to quality control than periodically finding and training support personnel at the site of each project. Such a support services contract for conducting clinical research will facilitate achieving NIEHS goals which are to identify and understand genetic susceptibility and environmental influences in human disease, and develop prevention and intervention strategies for reducing these same human diseases.

NIEHS的临床研究计划在壁内研究部门内进行或监督临床研究。这些研究的目标是：1）研究遗传易感性与环境因素之间的相互作用与人类种群中的复杂性状和疾病有关； 2）通过使用治疗，手术或辐射技术来减少遗传和环境风险因素，或通过改变环境暴露，饮食和生活方式来干预疾病的发育或进展。该合同将为OCR中的主要研究人员（PI）提供所有类型的支持，并且需要进行观察性临床研究和介入临床试验所需的DIR。尽管DIR内的临床研究一直在进行中，但它受到CRP中人员人数的严重限制，执行各种任务所需的支持人员缺乏支持人员，并且缺乏已经确定的患者护理和进行临床试验的机制。此外，DIR员工在各个地方（尤其是对于较小的研究）进行临床研究可能是昂贵，困难或根本不可行的。私营部门的努力现在存在着在许多阶段经验的国家网络，并可以更有效地提供这种支持。特别是对于小型项目，与每个项目站点的定期查找和培训支持人员相比，一个中央管理概念下的一组支持人员将更有效，提供更多的连续性，并受到质量控制。进行临床研究的这种支持服务合同将有助于实现NIEHS目标，这些目标将确定和理解人类疾病中的遗传易感性和环境影响，并制定预防和干预策略来减少这些相同的人类疾病。