Considerations for clinical trial design with obesity-related devices

Herbert Lerner, Martha W. Betz
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引用次数: 1

Abstract

Abstract Diet and exercise as a first line therapy do not appear to adequately address the epidemic of obesity seen worldwide. In the US there have only been two devices legally marketed in the last 10 years intended to treat obesity, with many more under clinical investigation. New drugs have recently been approved and, although they appear to provide some benefit, the use of these is associated with many side-effects and with an uncertain sustained weight loss. Using the benefit–risk paradigm as a basis for future study design, this editorial discusses the significant issues associated with the clinical trials intended to provide data to support the safety and effectiveness of new devices for obesity. Some of these issues include the choice of the appropriate study end-points, duration of the study, the need for sham comparators, and patient preference. Ideas are then proposed for future studies to aid in getting new devices to market.
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使用肥胖相关装置进行临床试验设计的考虑
饮食和运动作为一线治疗似乎不能充分解决肥胖在世界范围内的流行。在美国,在过去的10年里,只有两种用于治疗肥胖的设备合法上市,还有更多的设备正在临床研究中。新的药物最近被批准,虽然它们似乎提供了一些好处,但使用这些药物有许多副作用,并且不确定是否能持续减肥。利用获益-风险范式作为未来研究设计的基础,这篇社论讨论了与临床试验相关的重要问题,旨在提供数据来支持治疗肥胖的新设备的安全性和有效性。其中一些问题包括选择适当的研究终点、研究的持续时间、是否需要假比较器以及患者的偏好。然后为未来的研究提出想法,以帮助将新设备推向市场。
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