On-site Supervision Summary Of "Acupuncture And Clomiphene Citrate On Live Birth In Infertile Women With Polycystic Overy Syndrome:Randomized Controlled Trail"

The purpose of clinical research is to improve the clinical efficacy of traditional Chinese medicine and the ability to prevent and treat diseases.The current China and the world,with the socio-economic development,the development of evidence-based medicine and the introduction of methodologies,making the traditional medicine to carry out collaborative innovation situation,people pay more attention to the high incidence or the refractoriness of disease.Chinese medicine "globalization" is the trend,and the challenge we face is how to demonstrate effective and safe clinical evidence of Chinese medicine.Objective:Interpretation of "Acupuncture And Clomiphene Citrate On Live Birth In InfertileWomen With Polycystic Overy Syndrome:Randomized Controlled Trail"(PCOSAct),Take the domestic and foreign personnel with different professional backgrounds of the joint monitoring,combined with the project characteristics of quality control and on-site monitoring results of qualitative and quantitative analysis,to explore suitable for infertility clinical trial quality management and on-site monitoring,share experiences and ideas.Methods:This study focuses on the measures and implementation of quality control of large clinical trials and pay more attention to one of the important measures of quality control:on-site monitoring.This study comprehensively analyzes of the necessity,procedures,requirements and results of on-site monitoring of large clinical trials and summarizes the 3 × 25 monitoring report data formed by the three on-site monitoring conducted by the PCOSAct project.Results:1.Through the three monitoring of the sub-centers,it was found that the total number of deviation events was 160.Of these,the number of deviations monitored for the first time accounted for about 51%of the total number(82/160),and the second was about 37%(59/160),the third about 12%(19/160),it was a downward trend.2.There were five main types of items in the monitoring:① the subject didn’t complete protesterone and HCG tests every week;② Tthe subject received treatment before finishing all screening procedure;③the subject lost medicine or bottle(which didn’t cause medication mistake);④ test drug loss or bottle loss;⑤the subject didn’t complete 2 times acupuncture therapies every week。3.The correlation between the 5 types of events with the largest number of deviation events through the three monitoring:The comparison between the first and the third monitors χ2=21.537,p=0.001<0.05,has significant differences.The results showed that:monitoring of the key events,A subjects did not carry out weekly progesterone and HCG detection and B subjects did not complete the screening of the group to receive treatment;these two deviations from the rate of reduction is better than other events.The second and the third were compared with P=0.003<0.05,and the same result was obtained.The first surveillance compared with the second P=0.996,no difference.Conclusion:1.On-site monitoring is one of the important measures to carry out quality control of large-scale clinical trials.2.On-site monitoring is an essential and effective means of monitoring deviations from program events.3.The early start of clinical trials for quality control management is necessary.4.The efficient of the PCOSAct project monitoring is reflected in the preparation of the pre-monitoring,the appointment of the Ombudsman,the training of the sub-center assistant,the monitoring and centralized monitoring of the group.5.It is very necessary to monitor the monitoring of the key points of the various sub-centers,to write the monitoring reports,to count the number of statistical problems and to make timely feedback.This will help the project team to focus on solving the key issues during the supervision,improve the efficiency of supervision and ensure the quality of supervision.6.Strengthen the whole process,the depth of the domestic and international cooperation model,attention to interdisciplinary professional joint monitoring.This is conducive to promoting exchanges and cooperation,to achieve analysis and research a specific problem as soon as possible,to ensure the quality of project research.