临床试验质量影响因素分析

Influencing factors of qualities of clinical trials

目的:了解临床试验质量的影响因素及其影响大小。方法:通过临床试验质量影响因素调查问卷,对227位(52.4%)临床监查员(clinical research associate,CRA)和206位(47.6%)临床研究协调员(clinical research coordinator,CRC)进行调查,验证并探索影响我国临床试验质量的主要因素。结果:本次调查共收回434份问卷,合格并用于分析的有效问卷416份(CRA:218份;CRC:198份),合格率95.8%。CRA年龄范围在21~55岁,平均年龄(29.46±4.34)岁;CRC年龄范围在21~42岁,平均年龄(26.99±3.51)岁。CRA及CRC从业年限≤2年的比例分别为17.9%和57.6%,CRC的从业年限相对较短。影响我国临床试验质量的主要因素有:临床试验要求与医院常规操作不符(75.7%)、操作细节不清楚(74.8%)和未纳入本地研究者意见(占53.1%);研究中心缺乏研究药物管理及本地实验室检测的标准操作规程(standard operation procedure,SOP),仅分别有52.5%及40.3%的研究中心建立了相应的SOP;并且在上述SOP建立的过程中,仅有28.9%与临床试验的监管部门、申办方/CRO公司进行了沟通,这些SOP在执行中的可操作性及依从性可能存在潜在困难。结论:临床试验的开展是一个持续发生发展的过程,临床试验的质量问题可能出现在临床试验开展过程中的任何一个环节,临床试验方案的设计是临床试验的最初始步骤,完善的SOP建立及遵守并进行充分的培训,可全程对临床试验质量"保驾护航"。严把上述质量影响因素的每一关,对确保临床试验的质量都起到至关重要的作用。

Objective ： the factors. coordinators investigate the influencing factors of qualities of clinical trials and the weight of Methods： Totally 434 clinical researc （ CRC： 206, 47.6% ） participated the onnaire＇. The influencing factors of qu otal of 434 questionnaires were collected h associates （CRA： 227, 52. 4% ） and clinical research survey and completed the ＇clinical trial quality influencing alities of clinical trials in China were explored and verified. , and 416 valid questionnaires were used for analysis, with an effective rate of 95.8%. The CRA＇s age ranged from 21 to 55 CRC＇s age ranged from 21 to 42 y with an average age of （26 y, with an average age of （29.46±4.34） y; the 99 ± 3.51） y. The percentages of CRA and CRC with experiences in clinical trial industry of less than or equal to 2 years were 17.9% and 57.6% , respectively. In general, the CRCs had short working experiences. The investigation showed that the key influencing factors of clinical trial quality were as follows： the requirements of clinical trials protocol differed from common medical practices （75.4%） ; details of operational procedures were not clearly defined （74.6%） ; the sites lack standard operation procedures （SOP） on investigational product management as well as local lab tests, with only 52.5% and 40.3% of sites having SOPs established and in place; in addition, during the SOP establishing process, only 28.9% had communications with regulation agencies and sponsors/CROs, in which case there may exist potential operability and non-compliance issues when implementing those SOPs. Conclusion： Conduction of clinical trial is an ongoing process, quality issue can occur in established ＆ followed the integrated SOPs and throughout the life cycle of the trials, strictly c the clinical trial qualities. any of the procedure, protocol design is the gave sufficient traini ontrol any of the abo ng, can secure the ore most ori rall clini ve influencing factor, it can be ginal procedure, cal trial qualities crucial to assure