临床研究不良事件报告标准及报告质量探讨

Discussion on the Reporting Standards and Quality of Adverse Events in Clinical Researches

目的探讨临床研究不良事件的报告标准与数据质量要求。方法分析3种情况下不良事件的报告标准,举例说明Med DRA编码对不良事件报告原始数据的质量要求。结果 1研究疾病的加重:研究疾病预期的自然进展不视为不良事件,除非其疾病的变化形成了新的医学诊断。2异常的实验室检查结果:异常实验室检查值只有在其伴随临床症状或体征,或需要接受医疗干预,或研究者评价具有临床意义时,才被视为不良事件。3反复出现的不良事件:转归为痊愈或消失的不良事件再次出现时,需要再报告一条AE。4用Med DRA字典进行编码,要求原始数据应是清晰、简洁、完整和准确的。结论在制定方案时,应对不良事件的报告标准给出尽量具体的规定,试验启动前做好相关培训,以统一报告标准,提高原始数据质量。

Objective To discuss the reporting standards and quality of adverse events （AEs） in clinical researches. Methods The reporting standards of AEs on three occasions were analyzed and the quality requirements of the original data when coding with MedDRA terminology were illustrated. Results ① Aggravation of researched diseases： the natural course of diseases is not considered as AEs unless it develops into a new diagnosis. ②Abnormal results of laboratory examinations： there are three occasions in which abnormal results are regarded as AEs, along with clinical symptoms or signs, the need of implementing medical intervention, clinically significant. ③Repeating AEs： it is neces-sary to report another AE once a disappeared or recovered AE happens again. ④The original data should be clear, concise, complete and accurate if AE terms are coded with MedDRA terminology. Conclusion The standards of AE reporting should be specified in study protocols and conduct trainings before starting a trial in order to unify the reporting standards and improve the quality of original data.