讨论抗肿瘤新药临床试验院内质控的关键点

Discussion on key points of quality control in hospital in clinical trials of new antitumor drugs

目的:恶性肿瘤是威胁人类健康的一种严重疾病,WHO组织的调查显示,恶性肿瘤超过心血管疾病,在致死原因中居于首位。就目前而言,针对肿瘤的治疗以药物和手术为主,患者用药治疗时,如何提高药物功效、减少不良反应,成为患者关注的重点。内科肿瘤学是一门新的学科,相关研究工作比较活跃,而且该学科的发展和抗肿瘤新药的发展密切相关。本文以抗肿瘤新药临床试验为核心,首先指出常用的评价指标,然后阐述质量控制体系和院内质控的关键点,最后总结提高临床试验质量的建议和措施,以供参考。

Malignant tumor is a serious disease that threatens human health,the investigation of WHO organization shows that malignant tumor is the leading cause of death,which has surpassed cardiovascular disease.At present,drugs and surgery are the main treatments for cancer,in drug treatment,how to improve drug efficacy and reduce adverse reactions has become the focus of attention of patients.Medical oncology is a new discipline,and the related research work is relatively active,and the development of this discipline is closely related to the development of new anti-tumor drugs.This paper focuses on the clinical trials of new anti-tumor drugs.Firstly,itpoints out the commonly used evaluation indexes,then expounds the key points of quality control system and hospital quality control,and finally summarizes the suggestions and measures to improve the quality of clinical trials.