摘要：结合体外诊断试剂相关法规和此类试剂临床用途，分析其临床研究的主要要求。对该类试剂的伦理要求、临床试验方案、临床研究单位的选择、临床对象的选择、对比方法的选择、统计学分析、临床试验总结报告撰写等方面进行了详细解析。阐述乙型肝炎病毒基因分型检测类体外诊断试剂的临床研究要点。为从事上市前临床研究的行业人员提供参考。

Abstracts: Combined the current regulations with In Vitro Diagnostic reagent’s own characteristics, the special requirements for clinical research were analyzed. The ethical requirements for this kind of reagents, clinical trial scheme, the choice of clinical research unit, the selection of clinical objects, contrast method, statistical analysis, clinical trial summary report writing and so on has been analyzed in detail. The main points of clinical trials of the hepatitis B virus genotype detection reagents were discussed. It will provide the reference information for relevant personnel in pre-market clinical research.