Hemminki E
Eur J Clin Pharmacol. 1981 Feb;19(3):157-65. doi: 10.1007/BF00561942.
The purpose of the present study was to investigate the quality of trials used in support of applications for licensing drugs. All applications for psychotropic drugs received by the Finnish and Swedish drug control authorities in the years 1965, 1970, 1974, and 1975 were studied. In addition, a random sample of applications for "other drugs" was selected in Finland. All reports of clinical trials on the therapeutic efficacy of the drugs were included. Many trials were uncontrolled, and in controlled trials major drawbacks in the quality of the trial design and in the accuracy of reporting were often found. The number of patients in each controlled trial was small, and the majority of trials concerned selected groups of patients. Measures of effectiveness were often such that it was impossible to establish the overall benefit of the drug. Treatment times were short. Adverse effects were handled separately and were not adequately combined with efficacy. When a decision about licensure of a drug is made, it is not enough to know that the drug affects body systems, but its therapeutic value should also be established. The trials attached to the applications for licensing did not usually do that.
本研究的目的是调查用于支持药品许可申请的试验质量。对芬兰和瑞典药品监管当局在1965年、1970年、1974年和1975年收到的所有精神药物申请进行了研究。此外，在芬兰随机抽取了“其他药物”的申请样本。纳入了所有关于药物治疗效果的临床试验报告。许多试验是无对照的，在对照试验中，经常发现试验设计质量和报告准确性存在重大缺陷。每个对照试验中的患者数量很少，而且大多数试验涉及特定的患者群体。疗效衡量标准往往使得无法确定药物的总体益处。治疗时间很短。不良反应单独处理，没有与疗效充分结合。在做出药品许可决定时，仅仅知道药物对身体系统有影响是不够的，还应确定其治疗价值。附在许可申请上的试验通常没有做到这一点。
