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[如何改善患者及研究者对临床试验的了解:以法国肿瘤学临床试验登记处为例]

[How to improve patients and investigators' information on clinical trials: the example of French registry for clinical trials in oncology].

作者信息

Pauporté Iris, Manach E, Bachouche N, Hommais A, Détry S, Legrand-Lane C, Barbare J-C

机构信息

Institut national du cancer, Boulogne-Billancourt, France.

出版信息

Bull Cancer. 2008 Dec;95(12):1227-32. doi: 10.1684/bdc.2008.0753.

DOI:10.1684/bdc.2008.0753
PMID:19091658
Abstract

Cancer patients' willingness to be informed about clinical trials (CT) is rapidly increasing. Health professionals are also interested on being informed on CT in order to provide their patients the best access to innovative treatments. The French cancer plan (2003-2007) launched the creation of a national registry for clinical trials in oncology. The primary objective was to guarantee patients and investigators comprehensive, high quality and updated information about ongoing CT in France, accessed at www.e-cancer.fr. A second objective was to establish a single channel for registration of French CT in conformity with the requirements of the International Committee of Medical Journal Editors. A unique Web access for patients and investigators was created. Information important for patients is presented in the first pages. Scientific information is accessible under further clicks. An information page about clinical research, intended for patients and their relatives, was also prepared in collaboration with patients' advocacy and healthcare professionals. Achieving comprehensiveness is one of the founding principles of the RECF. Over 600 CT were registered as of end of July 2008. All French academic sponsors have registered their CT; the publication of the industrial trials has begun in early 2008.

摘要

癌症患者了解临床试验(CT)的意愿正在迅速上升。医疗专业人员也希望了解临床试验,以便为患者提供获得创新治疗的最佳途径。法国癌症计划(2003 - 2007年)启动了肿瘤学临床试验国家登记处的创建。主要目标是确保患者和研究人员能够获取有关法国正在进行的临床试验的全面、高质量且最新的信息,可通过www.e-cancer.fr网站获取。第二个目标是建立一个符合医学期刊编辑国际委员会要求的法国临床试验单一登记渠道。为患者和研究人员创建了唯一的网络访问途径。对患者重要的信息显示在首页。进一步点击可获取科学信息。还与患者权益倡导者和医疗专业人员合作,为患者及其亲属准备了一个关于临床研究的信息页面。实现全面性是法国癌症临床试验登记处(RECF)的基本原则之一。截至2008年7月底,已有600多项临床试验进行了登记。所有法国学术赞助商都已登记了他们的临床试验;工业试验的公布已于2008年初开始。

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