School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China.
Trials. 2010 May 26;11:64. doi: 10.1186/1745-6215-11-64.
Public confidence in clinical trials has been eroded by data suppression, misrepresentation and manipulation. Although various attempts have been made to achieve universal trial registration- e.g., Declaration of Helsinki, WHO clinical Trial Registry Platform (WHO ICTRP), the International Committee of Medical Journal Editors requirement- they have not succeeded, probably because they lack the enough power of enforcement.Legislation appears to be the most efficient and effective means to ensure that all researchers register their trials and disseminate their data accurately and in a timely manner. We propose that a global network be established. This could be accomplished in two steps. The first step is to legislate about trial registration and data transparency, such as USA's FDAAA Act 2007; and the second step to establish a global network to ensure uniform, international consistency in policy and enforcement of trial registration and data transparency.
公众对临床试验的信心已经被数据掩盖、歪曲和操纵所削弱。尽管已经做出了各种努力来实现临床试验的全球注册，例如《赫尔辛基宣言》、世界卫生组织临床试验注册平台（WHO ICTRP）、国际医学期刊编辑委员会的要求，但这些努力都没有成功，可能是因为它们缺乏足够的执行力度。立法似乎是确保所有研究人员准确、及时地注册他们的试验并传播他们的数据的最有效和最有效的手段。我们建议建立一个全球网络。这可以分两步完成。第一步是立法规定临床试验注册和数据透明度，例如美国的 FDAAA 法案 2007 年；第二步是建立一个全球网络，以确保在政策和执行临床试验注册和数据透明度方面的统一和国际一致性。
