Richards Duncan
Department of Clinical Pharmacology, University of Oxford, Radcliffe Infirmary, Woodstock Road, Oxford, OX2 6HE, UK.
Expert Opin Drug Saf. 2003 Sep;2(5):509-11. doi: 10.1517/14740338.2.5.509.
Most of the advertising material and articles in scientific journals about new drugs focus on their potential benefits. Data on the safety and tolerability of drugs are collected and carefully analysed during clinical trials, but the scope of this information is limited. Safe use of medicines requires a balanced assessment of both risks and benefits. This symposium at the Royal College of Physicians sought to highlight current issues in assessing the risks associated with prescription medicines. The result was a lively and informative debate with insights and challenges for prescribers and drug developers alike. This report focuses on the issues of most interest to drug developers.
科学期刊上关于新药的大多数广告材料和文章都聚焦于其潜在益处。药物的安全性和耐受性数据在临床试验期间会被收集并仔细分析,但这些信息的范围是有限的。安全用药需要对风险和益处进行平衡评估。皇家内科医学院举办的这次研讨会旨在突出评估处方药相关风险方面的当前问题。结果是一场热烈且信息丰富的辩论,为开处方者和药物开发者都带来了见解和挑战。本报告聚焦于药物开发者最感兴趣的问题。