支持抗肿瘤新药进入临床试验的非临床评价要点及关注问题

Non-clinical evaluation of conduct of human clinical trials for new anticancer drug

新药非临床评价的主要目的是决策新药能否进入临床试验。抗肿瘤新药非临床评价中的利弊权衡需考虑到肿瘤疾病及其药物应用特点。多数抗肿瘤药物常伴有严重的不良反应,其临床受试对象多为临床治疗效果较差或根本无有效治疗方法的病人。若新药具有有效性的优势或特点,潜在毒性风险小于疾病自身危险,此时是可以考虑接受新药进入临床试验。本文主要根据该思路对非临床研究中的药效学、毒性实验、药动学进行技术审评,对临床前研究结果的支持性或存在问题进行评价。此外,本文也较为详细讨论了非临床评价的考虑要点及其关注问题。

The key role of non-clinical evaluation for a new drug is to predict whether the clinical trial could be held. Risk-benefits evaluation for anticancer drugs is needed to consider the correlative characteristics cancers of different with application of drug category. Most anticancer drugs possessing serious adverse reactions in therapeutic doses, together with the advanced cancer patients composing the major subjects of poor or nonresponsible to conventional clinical treatment, therefore with a new drug efficacious therapeutic options and less toxic risk than the disease itself could be accepted for clinical trials. Based on this theoretical concept, this article will discuss the rationality of the non-clinical evaluation for new anticancer drugs including the effectiveness, toxicity and pharmacokinetics. Moreover, some considerations and correlative problems for non- clinical evaluation in anticancer drugs are also presented.