A PHASE III TRIAL OF CELECOXIB IN BASAL CELL NEVUS SYNDROME

描述(申请人提供)：我们现在已经完成了四年周期中的三年。 在此期间，GCRC新的计划指导小组的主要目标是解决 在以前的审查中发现的不足之处，并继续为未来建立我们的计划。我们已经完成了住院部的翻新，现在有一个最先进的设施来 开展临床研究。我们已经将我们的核心实验室搬迁到住院部附近的新的、更新的和方便的空间。我们在所有活动领域都提高了生产力，A天和访问次数、礼仪数量、调查人员的数量和多样性稳步增长，医科学生和博士后培训人员的数量增加，培训活动范围扩大。与此同时，GCRC调查人员大幅提高了出版效率。我们新的研究对象倡导者(RSA)计划在帮助和教育GCRC调查人员在研究对象同意、安全监控和法规遵从性方面发挥了重要作用。核心实验室扩大了其在基因组学和其他DNA技术方面的服务，我们新的运动生理学和身体成分实验室一直在为越来越多的研究人员提供服务。GCRC上的活动和兴奋程度从未像现在这样高。在这项相互竞争的更新提案中，66名不同的首席研究人员将在几个领域执行89项方案，包括结缔组织疾病和其他疾病的遗传流行病学、药物遗传学、痴呆症研究、癌症的基因表达谱、艾滋病毒的自然病史和发病机制、慢性病的运动生理学，以及代谢研究，重点是肥胖症、高血压、骨丢失和糖尿病的发病机制和治疗。这些是对其他几个已经在进行的项目的补充，包括肿瘤学和药物成瘾的精神药理学。随着人口老龄化，这些领域涵盖了许多新出现的关键健康问题。在接下来的5年里，我们的重点将是继续扩大GCRC的培训；继续扩大我们的协议多样性；投资并扩大新的实验室和信息学技术，使GCRC的研究人员能够应对未来的研究挑战。为此，我们正在请求新的资源，以扩大我们在数据库设计、基因组学能力和 运动生理学。在这样做的同时，我们将继续以患者护理、道德、安全和法规遵从性的最高标准进行这项研究。

DESCRIPTION (provided by applicant): We have now completed three years of a four-year cycle. The primary aim of the new program direction team of the GCRC during this time was to address shortcomings identified in previous reviews and to continue to build our program for the future. We have completed the renovation of our inpatient unit and now have a state-of-the-art facility to conduct clinical research. We have relocated our Core Laboratory to new, updated and convenient space near the inpatient unit. We have improved our productivity in all spheres of activity, with steady growth in number of A days and visits, number of protocols, number and diversity of investigators, increased number of medical students and post-doctoral trainees on the unit and expansion of the scope of training activities. This has been accompanied by a substantial increase in publication productivity by GCRC investigators. Our new Research Subject Advocate (RSA) program has played an important role in assisting and educating GCRC investigators in the areas of research subject consent, safety monitoring and regualtory compliance. The Core Laboratory expanded its services in genomics and other DNA technologies, and our new Exercise Physiology and Body Composition Laboratory has been providing services to a growing number of investigators. The level of activiy and excitement on the GCRC has never been higher. In this competing renewal proposal, 66 different principal investigators will perform 89 protocols in several areas including genetic epidemiology of connective tissue diseases and other disorders, pharmacogenetics, dementia research, gene expression profiling in cancer, HIV natural history and pathogenesis, exercise physiology in chronic diseases, and metabolic research with an emphasis on pathogenesis and treatment obesity, hypertension, bone loss and diabetes mellitus. These complement several other already active programs including oncology and psychopharmacology of drug addiction. These areas cover many of the emerging critical health issues as the population ages. Our focus over the next 5 years will be to continue to expand training on the GCRC; continue to expand our protocol diversity; and invest in and expand new laboratory and informatics technologies to allow the GCRC investigators to meet the research challenges of the future. To this end, we are requesting new resources to expand our services in database design, genomics capabilities and exercise physiology. As we do so, we will continue to perform this research with the highest standards of patient care, ethics, safety and regulatory compliance.