Design, Analysis, & Interpretation of RCTs in Obesity

设计、分析、

• 批准号: 7225163
• 负责人: DAVID B ALLISON
• 金额: $ 2.5万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-25 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7225163
• 关键词: clinical trials; experimental designs; meeting /conference /symposium; obesity; travel

DESCRIPTION (provided by applicant): Obesity is a serious condition that is associated with and believed to cause much morbidity, reduced quality of life, and decreased longevity. The most recent figures from the Centers for Disease Control indicate that obesity continues to increase in prevalence in the overall US population. Currently available treatments are only modestly efficacious and rigorously evaluating new (and in some cases existing) treatments for obesity is clearly in order. Conducting such evaluations to the highest standards and so that they are maximally informative requires an understanding of best methods for the conduct of randomized clinical trials in general and how they can be tailored to the specific needs of obesity research in particular. In response to recent Medicare calls for increased evaluation of obesity treatments, a FDA meeting on open questions in the conduct of obesity treatment trials, and high profile editorials in general medical journals questioning the way we design, execute, analyze, and interpret randomized clinical trials in obesity research, we propose a two-day meeting in which leading obesity researchers and methodologists convene to discuss best practices for randomized clinical trials in obesity. The meeting will take place in December of 2006 and be attended by scientists from academia, government, and industry.

描述（由申请人提供）： 肥胖是一种严重的疾病，与发病率、生活质量下降和寿命缩短有关，并被认为会导致这种情况。美国疾病控制中心的最新数据表明，美国总人口中肥胖症的患病率持续上升。目前可用的治疗方法效果有限，严格评估新的（在某些情况下是现有的）肥胖治疗方法显然是合理的。要按照最高标准进行此类评估，并使其提供最大程度的信息，需要了解一般进行随机临床试验的最佳方法，以及如何根据肥胖研究的具体需求进行调整。为了响应最近医疗保险呼吁加强对肥胖治疗的评估，FDA 召开了一次关于肥胖治疗试验中开放问题的会议，以及一般医学期刊上发表的高调社论质疑我们设计、执行、分析和解释随机临床试验的方式在肥胖研究中，我们建议召开为期两天的会议，由领先的肥胖研究人员和方法学家聚集在一起，讨论肥胖随机临床试验的最佳实践。这次会议将于 2006 年 12 月举行，来自学术界、政府和工业界的科学家将出席。