主要医学期刊上新药研究报告：乳腺癌的案例研究。

Reporting of studies on new medicines in major medical journals: a case study in breast cancer.

机构信息

Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute, University of South Australia, Australia.

出版信息

Clin Pharmacol Ther. 2010 Apr;87(4):398-400. doi: 10.1038/clpt.2009.278.

DOI:10.1038/clpt.2009.278

PMID:20305673

Abstract

A comparison of the results of pivotal trials on three new medicines for advanced breast cancer published in medical journals with those presented in the US Food and Drug Administration (FDA) reviews showed that analyses reported in journals were of lower quality and were given a favorable interpretation by minimizing toxicity and ignoring methodological shortcomings. Several proposals to strengthen the quality of reporting of clinical trials in medical journals and to support reliable assessment of the therapeutic value of new medicines are discussed.

摘要

将医学期刊上发表的关于三种新的晚期乳腺癌药物的关键试验结果与美国食品和药物管理局（FDA）审查中报告的结果进行比较后发现，期刊中报告的分析质量较低，通过最小化毒性和忽略方法学缺陷，对其进行了有利的解释。本文讨论了一些加强医学期刊临床试验报告质量的建议，并为可靠评估新药的治疗价值提供支持。