治疗药物监测类体外诊断试剂临床研究浅析

Analysis of Clinical Trials of in Vitro Diagnostic Reagents under TDM

目的旨在阐述治疗药物监测类体外诊断试剂的临床研究要点。方法结合体外诊断试剂现行法规和此类试剂自身特点,分析其临床研究的特殊要求。结果对该类试剂的管理分类、研究方法、临床试验方案设置、临床试验样本选择、结果的统计学分析以及临床试验报告撰写等方面进行了详细解析。结论治疗药物监测类体外诊断试剂的临床研究应从试剂本身的临床预期用途出发,科学、合理、完整地对试剂进行临床验证。

Objective To expound the main points of clinical trials of in vitro diagnostic reagents （IVD） under therapeutic drug monitoring （TDM）. Methods In conjunction with the current regulations of IVD and their own characteristics, the features of clinical trials were analyzed. Results Several aspects were analyzed in details including management classification of these reagents, study methods, clinical trial protocol design, sample selection, statistical analysis of results and report composing. Conclusion Clinical trials of TDM reagents should be carried out properly, scientifically and thoroughly based on their own intended clinical use.