Bergqvist D, Forbes C D, Minder C E, Planes A, Cate J W
Department of Surgery, University Hospital, Uppsala, Sweden.
Scott Med J. 1998 Apr;43(2):42-4. doi: 10.1177/003693309804300205.
In an increasing number of recent major clinical trials, independent safety committees or safety monitors have been involved. Their role and function is not yet defined and continues to evolve. The aim of this paper is to discuss the role and tasks of safety committees as a result of our collective experience as members of three safety committees of studies evaluating antithrombotic prophylaxis against postoperative deep vein thrombosis. We believe that the type of pharmacological intervention used is of less importance than the general experiences gained, which can be extrapolated to other studies and should stimulate a more general debate.
在最近越来越多的大型临床试验中，都有独立安全委员会或安全监测人员参与。它们的作用和功能尚未明确，且仍在不断演变。本文旨在根据我们作为三项评估抗血栓预防术后深静脉血栓形成研究的安全委员会成员的集体经验，探讨安全委员会的作用和任务。我们认为，所使用的药物干预类型不如所获得的一般经验重要，这些经验可以推广到其他研究中，并应引发更广泛的讨论。
