“十一五”国家科技支撑计划白血病课题设计特点与质控管理体会
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摘要
目前,中医药临床研究设计和实施中普遍存在一些影响疗效评价以及国际学术界认可的问题。在设计方面主要有:①多中心、随机、双盲安慰剂对照试验极少;②“随机”概念的误用或滥用;③疗效评价指标选择不当,疗效评价未能体现中医特色等;在课题实施过程中则缺乏科学的管理和严格的质量控制。
基于上述,在设计和实施“十一五”国家科技支撑计划“难治性急性白血病围化疗期中医干预治疗方案临床应用研究”(课题编号:2006BAIO4A18)时,在设计上我们采用国际上公认的标准临床试验方法,即随机、双盲、安慰剂对照、多中心临床实验原则。在项目实施过程中重点强调质量控制和科学管理,严格执行四级监查制度,接受科技部、支撑办、第三方质控小组稽查与监查,对分中心进行监查与培训,以保证最终得到真实可靠研究结果。
在设计方面重点考虑的是:研究方案符合伦理学问题,保证真正的随机,盲法设计以减少测量偏倚,计算合理的样本量,制定适宜疗效并体现中医优势的检测指标,采用合理的资料分析方法,对研究结果能够进行科学的解释等。
由于本课题具有协作单位多、方法学要求高的特点。因此,在方案实施过程中有一定的难度。故必须采取有针对性的措施,进行严格的质量控制和科学管理,以保证多中心临床试验达到研究方案的要求。
为保证课题顺利实施,笔者作为白血病项目组的二级监查员,一方面认真接受相关技术培训,曾先后8次参加科技部、支撑办、第三方质量控制小组的集中优化方案设计会议、培训和考核,提高了对临床研究设计的领会和实施中质量控制、管理的要点;另一方面在课题实施过程中在课题负责人指导下,奔赴6个研究中心,进行11次实地监查,召开实地培训会议11次,协助召开3次课题负责人培训会议,并在项目实施当中通过仔细观察,认真分析,反复实践来体会严格质量控制和科学管理必要性,并通过实地监查与培训保证了项目的研究质量。在实施过程中深刻体会到严格质量控制是项目顺利进展的保证,监查是质量控制的中心环节,培训是提高研究质量控制的基础,分中心质量控制员是项目实施的基层核心,也是质量控制关键环节所在。
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 programs
In 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.
基于上述,在设计和实施“十一五”国家科技支撑计划“难治性急性白血病围化疗期中医干预治疗方案临床应用研究”(课题编号:2006BAIO4A18)时,在设计上我们采用国际上公认的标准临床试验方法,即随机、双盲、安慰剂对照、多中心临床实验原则。在项目实施过程中重点强调质量控制和科学管理,严格执行四级监查制度,接受科技部、支撑办、第三方质控小组稽查与监查,对分中心进行监查与培训,以保证最终得到真实可靠研究结果。
在设计方面重点考虑的是:研究方案符合伦理学问题,保证真正的随机,盲法设计以减少测量偏倚,计算合理的样本量,制定适宜疗效并体现中医优势的检测指标,采用合理的资料分析方法,对研究结果能够进行科学的解释等。
由于本课题具有协作单位多、方法学要求高的特点。因此,在方案实施过程中有一定的难度。故必须采取有针对性的措施,进行严格的质量控制和科学管理,以保证多中心临床试验达到研究方案的要求。
为保证课题顺利实施,笔者作为白血病项目组的二级监查员,一方面认真接受相关技术培训,曾先后8次参加科技部、支撑办、第三方质量控制小组的集中优化方案设计会议、培训和考核,提高了对临床研究设计的领会和实施中质量控制、管理的要点;另一方面在课题实施过程中在课题负责人指导下,奔赴6个研究中心,进行11次实地监查,召开实地培训会议11次,协助召开3次课题负责人培训会议,并在项目实施当中通过仔细观察,认真分析,反复实践来体会严格质量控制和科学管理必要性,并通过实地监查与培训保证了项目的研究质量。在实施过程中深刻体会到严格质量控制是项目顺利进展的保证,监查是质量控制的中心环节,培训是提高研究质量控制的基础,分中心质量控制员是项目实施的基层核心,也是质量控制关键环节所在。
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 programs
In 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.
引文
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