重组干扰素α―2b注射液Ⅱ期临床试验中常见问题及解决方法.docVIP

重组干扰素α―2b注射液Ⅱ期临床试验中常见问题及解决方法 　　摘 要 在药物临床试验过程中，筛选失败率、受试者依从性与病例脱落率都将影响临床试验的进展和对药物有效性与安全性客观、准确的评价，影响临床试验的可靠性，最终影响用药安全和患者的身体健康。因此，对这3方面因素的控制已成为新药研发亟待解决的重要问题。本文通过重组干扰素α-2b注射液在4个研究中心进行的Ⅱ期临床研究试验，对其筛选失败率、受试者依从性和病例脱落率这3个方面进行数据统计、处理和分析，探究其原因，期望为今后药物临床试验工作的顺利开展，相关操作的规范，数据的完整准确提供合理的依据和保证，进而提高药物临床试验的质量。 　　关键词 临床试验 筛选失败率 依从性 脱落病例 　　中图分类号：R969.4 文献标识码：B 文章编号：1006-1533（2013）21-0026-05 　　The common problems and the solutions of the phaseⅡ 　　clinical trial of recombinant human interferon α-2b injection 　　WANG Xiaoli 　　（Jiangsu Cancer Hospital， Nanjing 210000， China） 　　ABSTRACT Clinical trials of drugs refer to a series of clinical pilot study on the drug effect in the human body in order to determine the efficacy and safety of drugs. During clinical trials， the rate of screening failure， the compliance of subjects and the rate of drop out can affect the progress of clinical trials and an objective and accurate evaluation on the efficacy and safety of the drug. They are the decisive factors which can interfere with scientific and reliable conclusions and even affect people’s safety and health ultimately. Therefore， the control and management of these factors has become an important matters in the clinical trials. Based on the phaseⅡclinical trial of recombinant human interferon α2b injection in the four research centers， the reasons for the rate of screening failure， the compliance of subjects and the rate of drop out were statistically studied so as to make sure that clinical trials of drugs can be successfully developed， the operation should be regulated， the relative data are complete and accurate and the quality of clinical trials can be improved. 　　KEY WORDS clinical trials； the rate of screening failure； compliance； drop out 　　药物临床研究是新药开发中不可或缺的环节，各项相关数据的正确性、真实性对于该药物的有效、安全性评价，以及指导医师日后临床用药都起着至关重要的作用[1]。 　　我国药物临床试验起步较晚，自20世纪90年代我国开始实施《药品临床试验管理规范（GCP）》，临床研究质量有了明显的提高，临床研究水平也逐步达到国际同行的标准。但是，我国至今还没有多少经过严格随机分组的大样本临床试验，更没有很多高水平的临床研究成果可以用来指导临床实践，主要原因可能是研究过程中一些不规范、不严谨的操作，例如，影