庆祝国际临床试验日

1747年5月20日,詹姆斯·林德开创了HMS索尔兹伯里(HMS Salisbury)的一项严重的审判。每天为一些机组人员提供两个橙子和一个柠檬,而另一些则为苹果酒,醋,硫酸或海水及其正常口粮提供,将Lind的实验评为医学史上最早的临床试验之一。250年后,他的开创性工作周年纪念日被庆祝国际临床试验日。Held annually by the National Institute of Health Research, the principles of Lind’s work still form the basis of modern clinical trials.

在一个评论forTrials,,,,大卫·萨克特(David Sackett)博士offers his perspective on more recent developments in clinical trials, evaluating the changes that have taken place over the last decade, and contemplating the future of trial practice. One noticeable change, Dr Sackett notes, is that patients are becoming ever more informed and demanding: ‘Patient groups are increasingly holding trialists’ feet to the fire and forcing us to honour our obligations to them and their diseases, illnesses, predicaments, and other patient-relevant outcomes, rather than focusing only on our interests and those of the drug and device industries.’ The commentary also highlights the growing number of trials conducted in the developing world by trialists hailing from those regions, and the higher levels of recognition this research is receiving.

临床试验的未来看起来是积极的,尤其是使用试验结果。正如注册临床试验已成为常态一样,也有人呼吁发布所有试验结果(无论结果如何)是一种既定的实践。这AllTrials initiative,2013年1月推出,正在采取速度,获得欧洲医疗机构的支持,许多患者团体和“大型制药”巨头,最著名的是葛兰素史克林,现在致力于在线发布所有试验结果。在许多研究人员看来,向所有结果发布的转变是重要的。专门出版空间的期刊结合在一起,以更有趣的积极发现以及研究人员发表不受欢迎的结果的沉默,导致了出版偏见,并且在医生和患者中对他们处方和服用的干预措施的不信任确实如此最适合患者。在问答中生物群落new online magazine from BioMed Central,Ben Goldacre博士Alltrials倡议的联合创始人讨论了该活动,以及它如何显着改变审判报告的格局。Goldacre博士评论说:“医生,患者,付款人和研究人员需要访问所有治疗中所有试验的结果,以便对哪种最好的决定做出明智的决定。应保留试验结果的想法是荒谬的,它只是破坏了基于证据的医学,并使医学专业暴露于合理的嘲弄。’

向所有结果发布的转变可以看作是使研究更广泛地为受过教育的公众以及那些直接使用此类研究结果的研究人员和临床医生提供更广泛的行动的一部分。去年,英国政府委托芬奇报告,建议议会要求将所有由公共资金资助的研究出版为“绿色”或“黄金”开放访问权限。大学和科学部长戴维·威利斯(David Willets)迅速宣布这一消息这1000万英镑将被指定为帮助引入此类政策。

作为公开通道的先驱,Biomed Central看到开放研究可以带来的好处。该杂志利用需要更高透明度的透明度的需求Trialsand all other BioMed Central journals that publish trials and trial protocols, demand that authors register their clinical trials as a condition of submission. To that end, BioMed Central runsCurrent Controlled Trials代表英国审判注册服务ISRCTN。迄今为止,登记册持有11,500多次试验的记录。Biomed Central也欢迎HRA建议‘to make the registration of clinical trials within an agreed timeframe a condition of ethics approval’ and ‘to work with publishers to dispel the myths and perceptions about the difficulties in publishing results’.

这publication of negative results is gaining more attention among researchers, and trialists in particular.Trialsjournal supports the publication of negative results, alongsideJournal of Negative Results,,,,established for the sole purpose of publishing unexpected results, or results that go against the current understanding.

如今,全球数十亿人将服用毒品 - 从扑热息痛片到抗逆转录病毒,这些毒品正在挽救生命和增强生命,并且已经通过了漫长的激烈测试过程。超过四分之一的千年研究人员已经完善了这一过程,并继续今天这样做,以确保詹姆斯·林德(James Lind)在HMS索尔兹伯里(HMS Salisbury)持久的工作中开始。

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