"11th Five-year National Science And Technology Support Program Leukemia Subject Design Features And Quality Control Management Experience

At present,there are some problems in clinical research design and implementation of traditional Chinese medicine,which effect the evaluation of the therapeutic effect of traditional Chinese medicine as well as international recognition.There are three main problems during design of traditional Chinese medicine clinical research:Firstly,double-blind, randomized,placebo-controlled multicentre clinical trials were rare.Secondly,the misuse of random concept.Finally,fail to choose suitable evaluation index of curative effect,which also can't embody the characteristics of traditional Chinese medicine.While during implementation process of the traditional Chinese medicine research,it is often lack of scientific management and strict quality control.Based on the above mentioned problems,when we implement traditional Chinese medicine interventional treatment clinical application research on refractory acute leucemia during chemotherapy period,which was one of national key technology R&D pillar program in the 11th five year plan of China(Research No:2006BAI04A18 ),taking double-blind, randomized,placebo-controlled multicentre clinical trial principle,according to national key technology R&D pillar program requirement and GCP standards,we emphasize scientific management and strict quality control during its implemention,and also strictly carry out four degree monitor policy of national key technology R&D.Receiving inspection from Ministry of Science and Technology,support office and third-party quality control group,we provide monitor and training to sub-centers in order to ensure reliable research result,thus can be recognized by internationally research organization.The key points of consideration in the design level:Research program should be in line with the ethical issues.How to ensure that the real random.In order to reduce measurement bias,we use double blind principle.Reasonable samples calculation.Choose suitable detection index,which not only reflect therapeutic effect and body the advantages of traditional Chinese medicine as well.Taking reasonable analysis of data,and scientific explanation of the result.In the implementation level,as a result of this issue in collaboration with multi-center and with emanding methodological characteristics,therefore there is a certain degree of difficulty in the implementation of the program,thus it is necessary to take measures to carry out strict quality control and scientific management,to ensure this multi-center clinical trial to follow the requirements of the implementation of research programsIn order to ensure the successful implementation of the subject,the author as a clinic monitor, on the one hand,receiving training 8 times,from that improving clinical study design level and understanding the main points of quality control and management in clinic research implementation.On the other hand,the author went to six research centers during the implemention of the subject,and independently responsible for monitoring 11 times,held training 11times,and assist to hold 3 times training to the Project sub-center Leaders,through specific measures to ensure strict quality control issues and scientific management.Through inspection and training to ensure the quality of the research topic,at the same time to accumulate the implementation experience,and to discover and solve problems in the implementation to ensure the successful implementation of the subject.It is conclude that the strict quality control is very important to proceed successfully,inspection is the central link to quality control,and the training is the basis to quality control,and the monitor of sub-center is the project core as well as the most basic and foundmental element of quality control and management.