GENETIC SUSCEPTIBILITY AND ENVIRONMENTAL FACTORS

遗传易感性和环境因素

• 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
• 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

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的临床研究项目在校内研究部门内进行或监督临床研究。这些研究的目的是：1）调查遗传易感性和环境因素之间的相互作用，这些因素与人群中复杂的性状和疾病有关; 2）通过使用治疗、手术或放射技术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，干预疾病的发展或进展。该合同将为OCR和ODR的主要研究者（PI）提供进行观察性临床研究和干预性临床试验所需的所有类型的支持。虽然在国家康复中心内一直在进行临床研究，但由于中心的人员数量有限，缺乏执行各种任务所需的支助人员，以及缺乏已经建立的病人护理和进行临床试验的机制，临床研究受到严重限制。此外，在不同的地方，特别是对于较小的研究，进行临床研究的工作人员，可能是昂贵的，困难的，或者根本不可行。私营部门的努力现在可以利用在这类工作的许多阶段都有经验的国家人员网络，可以更有效地提供这类支助。特别是对于小型项目而言，在中央管理概念下的一个支助人员小组将比在每个项目现场定期寻找和培训支助人员更有效率，提供更大的连续性，并更容易受到质量控制。这种临床研究的支持服务合同将有助于实现NIEHS的目标，即确定和了解人类疾病的遗传易感性和环境影响，并制定预防和干预战略，以减少这些人类疾病。