米格列奈钙片Ⅱ期药物临床试验质控中存在的问题

Quality control problems in phase Ⅱ clinical trial of Mitiglinide Calcium

目的 找出米格列奈钙片治疗2型糖尿病的Ⅱ期药物临床试验质控中存在的问题,以提高药物临床试验的质量。方法 于2012年5月-2015年8月对华中科技大学同济医学院附属荆州医院内分泌科参与米格列奈钙片Ⅱ期药物临床试验的64例受试者所有原始文件分多次逐一进行质控检查。结果 14（21.88%）份知情同意书签署时存在问题;6.25%的受试者签名及时间的地方签错;47.73%的不良事件及严重不良事件质控时存在问题;18.18%的不良事件无追踪;23（52.27%）例次的化验结果转抄到研究病历及病例报告表时错误,但没有影响判定;研究者写错后修改不正确有42例次,占总例数的95.45%。结论 质控中存在着签署的知情同意书有一部分不规范,如：研究者对受试者的不良事件及严重不良事件处理、判定及记录不合理,在将原始文件转抄到病例报告表时抄错,原始文件及病例报告表写错后修改不正确。因此医院不仅要加大质控力度,还要对研究者加大培训及管理力度,同时建立核对机制,以提高药物临床试验的质量。

Objective To identify the problems of quality control in Mitiglinide Calcium of phase Ⅱ drug clinical trials for type 2 diabetes treatment, in order to improve the quality of drug clinical trials. Methods Quality control checks were conducted for 64 participants from Department of Endocrinology, Jingzhou Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, they took Mitiglinide Calcium phase H drug clinical trials fiom May 2012 to August 2015 and checked all the original documents in nmhiple subjects one by one. Results 14 （21.88%） of informed consents had some problems when they were signed. 6.25% of the subjects had the wrong place for the time and signature. 47.73% of adverse events and serious adverse events had quality control problems. 18.18% of the adverse events had no trace record. 23 （52.27%） of laboratory test results had errors when they were transcribed to the study of medical records and case report forms, but the errors did not affect the judgment. There are 42 （95.45% of the total） cases in which mistakes still exist after researchers modified the errors. Conclusion Part of the informed consent is not standardized in quality control, such as researchers recorded and determination of the adverse events and serious adverse event unreasonably; some researchers copied the original documents wrong when transcribed into the case report forms and later modified incorrectly. So the hospital not only has to increase quality control, but also increase the training and management for researchers. In the meanwhile, the hospital has to build checking mechanism to improve the quality of drug clinical trials.