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晚期前列腺癌临床试验的设计:避免走入死胡同。

Design of clinical trials in advanced prostate cancer: avoiding the dead ends.

作者信息

Debruyne Frans M J

机构信息

Department of Urology, Radboud University Nijmegen Medical Centre, Geert Grooteplein 30, Nijmegen, the Netherlands.

出版信息

BJU Int. 2005 Dec;96 Suppl 2:47-53. doi: 10.1111/j.1464-410X.2005.05947.x.

Abstract

Despite more than 30 years of clinical trials, investigations in prostate cancer have not succeeded in making advances comparable to those in other branches of research, such as breast cancer. Indeed, prostate cancer trials have repeatedly run into a series of "dead ends", as investigators face the problems of inadequate funding for research, treatments that result in only minimal improvements in survival, and lack of treatment options that have sufficient prospects for success. This article briefly reviews the strategies behind clinical investigations into prostate cancer over the last three decades, evaluates the pitfalls that have hindered research, and makes suggestions for the appropriate design of clinical trials that are safe and beneficial to patients while maintaining cost-effectiveness and accountability to patients and society.

摘要

尽管进行了30多年的临床试验,但前列腺癌研究并未取得与乳腺癌等其他研究领域相媲美的进展。事实上,前列腺癌试验屡屡陷入一系列“死胡同”,因为研究人员面临着研究资金不足、治疗仅能带来微小生存改善以及缺乏有足够成功前景的治疗选择等问题。本文简要回顾了过去三十年前列腺癌临床研究背后的策略,评估了阻碍研究的陷阱,并就如何合理设计既安全有益患者又能保持成本效益并对患者和社会负责的临床试验提出建议。

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