Koopmans P P, de Graeff P A, van Zwieten-Boot B J, Lekkerkerker J F, Broekmans A W
College ter beoordeling van geneesmiddelen, afd. Klinische Beoordelingen Agentschap, Den Haag.
Ned Tijdschr Geneeskd. 2000 Apr 15;144(16):756-61.
The clinical criteria for admission of new drugs to the European common market have become more stringent in recent years. Increasingly often, the manufacturer is required to demonstrate that the new drug offers a clinically visible and relevant benefit to the patient. Efficacy and adverse effects should not only be studied by comparative trials with placebo, the registration authorities also expect the drug to be compared with the standard treatment already available. Such trials should prove that the balance between efficacy and adverse effects of the drug is better than that of placebo and at least as good as the standard treatment, as regards not only statistical significance but also clinical relevance. Therefore, Dutch and European assessment reports and product information may be increasingly useful to prescribers, patients and insurers in determining the role and therapeutic value of new drugs within the existing therapeutic possibilities concerning certain diseases.
近年来，新药进入欧洲共同市场的临床标准变得更加严格。越来越多地要求制造商证明新药能为患者带来临床上可见且相关的益处。疗效和不良反应不仅应通过与安慰剂的对比试验来研究，注册机构还期望将该药物与现有的标准治疗方法进行比较。此类试验应证明，就统计学意义和临床相关性而言，该药物在疗效和不良反应之间的平衡优于安慰剂，且至少与标准治疗相当。因此，荷兰和欧洲的评估报告以及产品信息对于开处方的医生、患者和保险公司在确定新药在某些疾病现有治疗可能性中的作用和治疗价值时可能会越来越有用。
