伴侣动物用细胞毒类抗肿瘤药临床试验设计及评价要点

Analysis of Clinical Trial Design and Evaluation Points of Cytotoxic Antitumor Drugs for Companion Animals

关键词:  临床试验  伴侣动物  细胞毒类抗肿瘤药  疗效评价

Key words:  clinical trial  companion animal  cytotoxic antitumor drug  efficacy evaluation

摘要:

肿瘤已经逐渐发展成为老年伴侣动物最为常见的疾病,而目前国内并无伴侣动物专用的抗肿瘤药。细胞毒类抗肿瘤药是治疗恶性肿瘤的主要手段之一,目前有许多兽药企业致力于此类抗肿瘤药的研发。本文以EMA和FDA发布的伴侣动物抗肿瘤药指导原则为依据,结合国家药品监督管理局药品审评中心(CDE)发布的抗肿瘤药物临床试验技术指导原则对比分析,对伴侣动物使用的细胞毒类抗肿瘤药研发过程中的临床试验设计关键技术要点进行了分析,旨在为伴侣动物用细胞毒类抗肿瘤药临床评价提供参考。

Abstract:

Neoplasia has gradually developed into the most commonly encountered disease in geriatric companion animals. Currently, there is no authorized anti-tumor drug specified using for companion animal in China. As cytotoxic antitumor drug is currently one of the main methods for treatment of malignant tumors, many veterinary drug companies are committed to do research and development for these drugs. This article is based on EMA and FDA guidelines associating with companion animal antitumor drugs in combination with the CDE"s technical guidelines for clinical trials of antitumor drugs. Key technical points of clinical trial designing in research and development process of companion animal cytotoxic anti-tumor drugs were reviewed in this article and to provide reference for the clinical evaluation of cytotoxic anti-tumor drugs for companion animals.