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[研究成果应免费获取!——病例报告显示与制药行业接触存在障碍]

[Research results should be freely accessible!-- Case reports demonstrate obstacles to contact with drug industry].

作者信息

Eliasson M, Bergqvist D

机构信息

Sunderby sjukhus, Luleå.

出版信息

Lakartidningen. 2001 Sep 12;98(37):3913-6.

Abstract

Recommendations on the use of medical technologies should be based on best available evidence. Publication bias due to delayed publication or non-publication of negative studies leads to inflated effect sizes in systematic reviews. We carried out a health technology assessment on prevention and treatment of venous thromboembolism, and in order to minimize publication bias asked the six pharmaceutical companies with antithrombotic drugs registered in Sweden to supply us with results from unpublished clinical trials. The answers were returned after 4 to 60 weeks, and with only one exception, after multiple reminders by telephone, fax and e-mail. No relevant unpublished studies were reported to us although we were made aware of two published studies that our literature search had not identified. One company did not mention a large negative unpublished clinical trial with their drug which has remained unpublished due to conflict between the company and the steering committee. We conclude that the companies did not contribute much and that the process was very time consuming with little result. As non-publication of trial results is unethical, we propose agreements between industry and researchers that all studies be prospectively registered and made publicly available.

摘要

关于医疗技术使用的建议应基于现有的最佳证据。由于阴性研究的延迟发表或未发表导致的发表偏倚会使系统评价中的效应量虚增。我们对静脉血栓栓塞的预防和治疗进行了一项卫生技术评估,为尽量减少发表偏倚,我们要求在瑞典注册了抗血栓药物的六家制药公司向我们提供未发表的临床试验结果。在通过电话、传真和电子邮件多次提醒后,4至60周后收到了回复,只有一个例外。尽管我们知晓两项我们的文献检索未发现的已发表研究,但没有公司向我们报告相关的未发表研究。一家公司未提及一项关于其药物的大型阴性未发表临床试验,该试验因公司与指导委员会之间的冲突而一直未发表。我们得出结论,各公司贡献不大,而且该过程非常耗时,结果甚微。由于不公布试验结果是不道德的,我们提议行业与研究人员达成协议,对所有研究进行前瞻性注册并公开。

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