加强临床监测研究 确保生物创新药的安全使用

Strengthening clinical monitoring research to ensure the safe use of biological innovative drugs

随着疾病发生的关键机制不断被揭示,以及现代生物制药技术的迅猛发展,越来越多的生物创新药获批上市。近年来生物创新药临床应用大大增加,但不良反应报道也逐步增多,因此构建生物创新药安全使用监管标准与体系的意义重大且临床需求迫切。当前阻碍生物创新药临床安全监管的主要问题,一是药物不良反应产生的机制不清,缺少预测相关不良反应的特异性检测指标;二是体内药物“暴露量-临床疗效-毒副反应”三者间关系研究程度不足,难以支撑安全用药“量与毒”规则的建立;三是缺乏符合中国人生理和病理特点的临床研究证据,新药临床研究理想化的随机对照试验结果不足以支撑真实世界安全用药。因此,必须加强生物创新药安全使用的监管意识,加快该类药物临床监测研究进程,揭示出更多临床安全用药的科学证据,助力生物创新药安全使用监管标准与体系的构建。

With the key mechanism of disease occurrence being revealed and rapid development of modern biopharmaceutical technology,more and more biological innovative drugs have been approved for marketing.With more clinical application of innovative biological drugs in recent years,more adverse reac⁃tions were reported.Therefore,it is of great significance and urgent in clinic to construct the supervision standard and system for the safe use of biological innovative drugs.At present,the main problems hindering the clinical safety supervision of biological innovative drugs are as follows.Firstly,the mechanism of adverse drug reactions is unclear and there is a lack of specific detection indicators to predict them.Secondly,the study on the relationship of"exposure⁃clinical efficacy⁃toxic and side effects"of drugs in vivo is still insufficient,so it is difficult to support the establishment of the rule of"quantity and toxicity"for safe drug use.Thirdly,there is a lack of clinical research evidence in line with the physiological and pathological characteristics of Chinese people,and the ideal randomized controlled trials results of clinical research on new drugs are not enough to support its safe drug use in the real world.Therefore,it is necessary to strengthen the supervision awareness of the clinical safe use,accelerate the process of clinical monitoring research on biological innovative drugs,reveal more scientific evidence of clinical safe use,so as to help the construc⁃tion of the supervision standards and system for the safe use of biological innovative drugs.