Sim Ida
Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, 400 Parnassus Ave., Rm. A-405, San Francisco, CA 94143-0320, USA.
J Gen Intern Med. 2008 Jan;23 Suppl 1(Suppl 1):64-8. doi: 10.1007/s11606-007-0300-7.
Recently, several pharmaceutical companies have been shown to have withheld negative clinical trial results from the public. These incidents have resulted in a concerted global effort to register all trials at inception, so that all subsequent results can be tracked regardless of whether they are positive or negative. These trial registration policies have been driven in large part by concern about the pharmaceutical sector. The medical device industry is much smaller, and different from the pharmaceutical industry in some fundamental ways. This paper examines the issues surrounding registration of device trials and argues that these differences with pharmaceutical should not exempt device trials from registration.
最近，有几家制药公司被证明向公众隐瞒了负面的临床试验结果。这些事件促使全球共同努力，在试验开始时就对所有试验进行登记，以便能够追踪所有后续结果，无论其是阳性还是阴性。这些试验登记政策在很大程度上是出于对制药行业的担忧。医疗器械行业规模要小得多，并且在一些基本方面与制药行业不同。本文探讨了围绕器械试验登记的问题，并认为与制药行业的这些差异不应使器械试验免于登记。
