从试验注册到结果公开进一步提高临床试验的透明化

Maximize transparency of clinical trial from trial registry to results disclosure

临床试验的结果公开和数据共享能真正让临床试验的研究价值得以实现。本文概述了国际上临床试验结果公开制度的发展历程和现状,包括EMA,FDA,WHO和国际医学杂志编辑委员会(ICMJE)在临床试验透明化方面政策的变化。同时讨论了临床试验结果公开的趋势和优势,并对国内临床试验结果公开的实施提出启示,例如CFDA可结合药物临床试验登记与信息公示平台逐步建立配套的临床试验公开制度,以及针对学术性临床试验可把研究结果公开作为基金资助的立项要求等多项建议,以期进一步为提高国内临床试验的透明化提供参考。

Clinical trial results disclosure and data sharing can fulfill the value of clinical trial. This paper introduce the history and current trends of the global clinical trial disclosure,including the policies development of EMA,FDA,ICMJE and WHO. Given the advantage of the full transparency of clinical trial,China should put more efforts on the clinical trial disclosure and improve the transparency of clinical trial,such as the CFDA establish the related policies to guide the clinical trial results disclosure on official registry platform,and the National Fund Committee enforce clinical data sharing as the requirement for the fund of academic clinical trials,in order to further improve the transpareney of domestic clinical trials.