以精神分裂症患者为受试者的生物等效性试验的实践与思考

Management of bioequivalence study with schizophrenia patients

目的探索以精神分裂症患者作为受试者的生物等效性试验管理模式。方法采用药物Ⅰ期临床研究室与精神科合作的运行管理模式,基于受试者及研究药物特点,通过筛选期有效知情同意、入住期落实特殊监护及随访期延续用药指导保护受试者权益。同时采取加强科室沟通、重视试验安全管理、关键节点合理排班的措施进行质量控制。结果 4项氯氮平试验共筛选入组104例,脱落5例,受试者同批入组,历时(24±1.22)d完成临床评价部分,数据分析均表明受试制剂与参比制剂具有生物等效性。结论该管理模式能够保证精神分裂症患者作为受试者临床试验的完成效率、试验质量和受试者依从性。

Objective To explore the management of bioequivalence study with schizophrenia patients as subjects.Methods Cooperation between the PhaseⅠClinical Trial Center and the Department of Psychiatry was established based on the characteristics of the subjects and the study drug.The rights and interests of the subjects were made clear and protected by effective informed consent during the screening period,special care during hospitalization and continuous medication guidance during the follow-up.At the same time,according to the design of the study,we strengthened the communication between departments,attached importance to the safety of the study,reasonably scheduled shift,and standardized dietary activities to control the quality.Results Totally 104 patients were recruited in four studies,and 5 patients were dropped out.Subjects were enrolled at the same time,and it took(24±1.22)days to complete the clinical evaluation.All four studies demonstrated bioequivalence between the clozapine tablets and reference tablets.No one was injured.Conclusion This cooperation management can ensure the efficiency,quality and compliance of patients with schizophrenia as subjects in clinical trials.