美国食品和药物管理局针对临床试验研究者发出警告信的分析

Analysis of warning letters issued to investigators by United States Food and Drug Administration

目的为我国药物临床试验管理提供探索方向。方法检索2013—2016年美国食品和药物管理局(FDA)针对临床试验研究者发出的警告信,统计警告信和其提及问题总数,分析年分布情况。将提及问题进行分类,分析各类问题的具体表现。结果共收集到2013—2016年FDA针对临床试验研究者发出的警告信31封,提及问题67个。主要问题包括违反入排标准等试验方案偏离问题、检验检查报告缺失等原始医疗记录/资料保存不完整问题及未获得知情同意书等知情同意相关问题。其中试验方案偏离问题每封警告信均有提及。结论我国药物临床试验相关方应重视试验实施过程中主要问题的管理,并可借鉴FDA的经验明确问题的责任主体及处理措施。

AIM To provide study direction for the management of clinical trial in China. METHODS Warning letters issued to investigators by the United States Food and Drug Administration （FDA） were retrieved from 2013 to 2016. The statistics of the warning letters issued and the findings mentioned were collected and the annual year distribution was summarized. The findings were classified and the specific examples of the findings were analyzed. RESULTS There were 31 warning letters issued to clinical investigators by FDA from 2013 to 2016, which showed 67 findings. The main findings included violation of inclusion and exclusion criteria, lack of auxiliary examination reports, fail to obtain informed consents which showed the major deficiencies related to deviation from the investigational plan, incomplete records for inspection and relevant issues of informed consents. Moreover, deviation from the investigational plan was mentioned in every warning letter. CONCLUSION The drug clinical trial stakeholders in China should pay attention to management of the main problems in implementation, and learn from FDA to define the responsibilities and the measures of all sides.