Ginestet D, Olié J P
Hôpital Paul Brousse, Villejuif.
Encephale. 1994 Apr;20 Spec No 1:187-94.
Preclinical trials are mainly concerned with toxicologic and behavioral studies in animals. Clinical trials, in man, require answers to several key-questions: confirmation of the superiority of the compound versus placebo, short, middle, and long-term studies for evaluation of efficacy and safety, international clinical criteria defining the experimental population, research of drug interactions, studies within specific types of population, especially ageing subjects. Heterogeneity of information, for the new antidepressive compounds, is explained by several factors: prescription to out- or in-patients, by general practitioners or specialists. The Marketing Authorization Committee and another committee called "Commission de transparence" assess the risk-benefit ratio, the indications of the drug (acute depressive reaction, prophylaxis of recurrences...), the medical benefit. But these advances in methodological procedures are questionable. Will they allow new discoveries, or, conversely, counteract an inventive clinical practice?
临床前试验主要关注动物的毒理学和行为学研究。人体临床试验需要回答几个关键问题：确认该化合物相对于安慰剂的优越性、进行短期、中期和长期研究以评估疗效和安全性、确定实验人群的国际临床标准、研究药物相互作用、在特定人群类型（尤其是老年受试者）中开展研究。新抗抑郁化合物信息的异质性可由多种因素解释：门诊或住院患者的处方情况、由全科医生还是专科医生开具处方。市场授权委员会和另一个名为“透明度委员会”的委员会评估风险效益比、药物的适应症（急性抑郁反应、复发预防……）以及医疗益处。但这些方法程序上的进展存在疑问。它们会带来新发现，还是相反，会阻碍创新的临床实践？
