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交流:是否应建立机制,以便临床试验研究者之间分享在设计、实施和分析中处理问题的经验?方法:支持加强交流的理由。

Communications: Should mechanisms be established for sharing among clinical trial investigators experiences in handling problems in design, execution, and analysis? Methodology: the case for improved communications.

作者信息

Meinert C L, Hawkins B S

出版信息

Clin Pharmacol Ther. 1979 May;25(5 Pt 2):754-7.

PMID:373968
Abstract

Despite their long history, the number that are in operation now, and the current level of expenditures on them, clinical trials have not been the focus of sufficient methodologic research. The paucity of metholologic explorations is further aggravated by the constraints on communications regarding methodology. Those individuals working in the area of clinical trials need to establish some professional identity with the field. Methodology in the areas of design and management of clinical trials needs to be stimulated, perhaps through special requests for applications (RFAs) and requests for proposals (RFPs). Communications could be improved by the establishments of a professional society, the development of an appropriate journal, and establishment of national training and information centers for clinical trials.

摘要

尽管临床试验历史悠久,目前仍在运行的数量众多,且在其上的当前支出水平也较高,但它尚未成为充分的方法学研究的重点。方法学探索的匮乏因方法学交流方面的限制而进一步加剧。从事临床试验领域工作的人员需要确立与该领域的某种专业身份。或许可以通过特殊申请要求(RFAs)和提案要求(RFPs)来推动临床试验设计和管理领域的方法学发展。通过建立专业协会、创办合适的期刊以及设立国家临床试验培训和信息中心,可以改善交流情况。

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