Carson Polly A
Department of Dermatology and Skin Surgery, Roger Williams Medical Center, Providence, RI 02908, USA.
Dermatol Ther. 2006 Nov-Dec;19(6):377-82. doi: 10.1111/j.1529-8019.2006.00095.x.
Clinical research plays a very important role in the development of drugs and devices, including those for wound healing. The process of initiating a clinical trial can be rather daunting, particularly with the ever-increasing regulatory hurdles. Many clinicians are generally either not trained or have limited knowledge of these matters. In this short review, the present authors discuss the 10 most important steps required in initiating a clinical trial. This information is applicable not only to wound healing studies, but also to other investigational trials.
临床研究在药物和器械(包括伤口愈合相关的药物和器械)的研发中起着非常重要的作用。开展一项临床试验的过程可能相当艰巨,尤其是面对日益增加的监管障碍时。许多临床医生通常要么没有接受过相关培训,要么对这些问题的了解有限。在这篇简短的综述中,本文作者讨论了开展一项临床试验所需的10个最重要步骤。这些信息不仅适用于伤口愈合研究,也适用于其他研究性试验。