国际著名医学期刊重申了药物临床试验准则

11家国际医学期刊在一篇联合社论中，重申了他们对2005年7月1日之后入选的临床试验的要求，必须在公共注册处登记，能够通过网络搜索，而且在第1例患者入选之前无须任何费用就能够进入。

这些期刊宣布，对在2005年7月之前开始入选的临床试验，只要在2005年9月13日之前完成登记，他们将接受回顾性的登记。这项申明扩大了在2004年9月由国际医学期刊编辑委员会(ICMJE)社论的要求。

《国际医学年报》编辑Harold Sox说：“我们的第一份社论旨在提醒研究人员、临床试验发起人和赞助人。这篇社论再次确认我们的意图，并告诉研究人员他们必须满足我们社论中提出的要求。”

ICMJE指出研究人员在登记临床试验的时候，不能省略关键信息。特别是他们必须指出治疗是有意义的，这样患者以及其他人就能够知道试验中的干预措施。建议临床试验发起人不要“使用无意义短语来描述关键的信息。”ICMJ采纳世界卫生组织的最小资料表格，该列表所要求的项目在每一项临床试验中都是必不可少的。

2005年5月23日ICMJE网站（www.icmje.org）公布了这篇社论。 这些医学期刊包括：《新英格兰医学期刊》、《挪威医学期刊》、《柳叶刀》、《美国医学会期刊》、《丹麦医学会期刊》、《克罗地亚医学期刊》、《新西兰医学期刊》、《加拿大医学会期刊》、《荷兰医学期刊》、《澳大利亚医学期刊》、《内科学年报》。
 
Medical Journals Repeat Drug Trial Rules
 
In a joint editorial, the editors of eleven international medical journals have repeated their requirement that clinical drug trials that begin enrollment on or after July 1, 2005, be registered in a public registry that is electronically searchable and publicly accessible at no charge before the first patient is enrolled.

The journals have announced they will accept retrospective registration of trials that began enrollment before July 2005 as long as registration is complete by September 13, 2005. This announcement amplifies the requirement stated in an editorial in September 2004 by the International Committee of Medical Journal Editors (ICMJE).

“Our first editorial was a wake-up call for researchers, trial authors, and sponsors,” noted Harold Sox, editor of Annals of Internal Medicine. “This editorial reaffirms our intent and tells researchers what they must do to meet our requirements for editorial review and subsequent publication.”

The ICMJE states that researchers must not omit key information when they register a trial. Specifically, they must name the treatment in a meaningful way so that patients and others know what intervention is under study. Authors are advised not to “use meaningless phrases to describe key information.” The ICMJE has adopted the minimal data set of the World Health Organization (WHO, Geneva, Switzerland), a list of required items that must be included in every trial.

The editorial was released on the ICMJE website (www.icmje.org) on May 23, 2005. Participating journals include The New England Journal of Medicine, Norwegian Medical Journal, The Lancet, The Journal of the American Medical Association, Journal of the Danish Medical Association, Croatian Medical Journal, the New Zealand Medical Journal, the Canadian Medical Association Journal, the Dutch Journal of Medicine, the Medical Journal of Australia, and the Annals of Internal Medicine.