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临床试验数据的真实性与准确性是极其重要的,任何失真性数据都可能影响临床试验结果,造成不可弥补的损失。笔者认为临床试验失真性数据,即包括主观造假的数据,也包括客观形成的不准确数据。笔者通过对临床试验失真性数据的一系列特征表述,探讨了辨识方法,并分析、归纳其产生的原因。这些原因包括对试验结果的主观干预、研究者GCP知识水平参差不齐、研究者对试验方案的理解与认识误差等。最终提出通过加强研究者及相关人员的科研素质教育、加强数据采集过程质量控制等手段来防止临床试验失真性数据产生的对策与建议。
The authenticity and accuracy of clinical trial data are extremely important, and any distorted data can affect the outcome of clinical trials and cause irreparable damage. I believe that clinical trial distortion data, that is, including the data of subjective fraud, but also includes the formation of inaccurate data objectively. Through a series of characterization of clinical trial distortion data, the author discusses the identification method, and analyzes and summarizes the reasons for its occurrence. These reasons include the subjective intervention of the test results, the uneven level of GCP knowledge of researchers, the researchers’ understanding and understanding of test protocols, and so on. Finally, some countermeasures and suggestions are put forward to prevent the distortion of clinical trial data by strengthening the quality education of researchers and relevant personnel and strengthening the quality control of data collection process.