基于Kano模型的新药研发项目风险识别与可控性研究

发布时间：2018-10-14 08:22

【摘要】：目的鉴于全面风险管理和内部控制一体化发展的趋势,结合新药研发项目风险管理的必要性及Kano质量分类方法在风险管理研究中的可行性,本研究通过文献研究构建了新药研发项目风险因素集,在系统研究Kano质量模型的定义、结构的基础上提出Kano风险属性归类法进行风险因素分类评价,结合药品研发与风险管理专家对风险后果严重程度、可控程度的评分实现风险严重性、可控性评价,制定风险应对措施,确保风险内控活动的顺利开展,促进研发项目成功,以最少的管理成本实现最有效的风险控制。研究结果对于增强医风险药企业新药研发能力和风险内控能力、实现风险管理资源优化配置、满足消费者药品需求具有极强的现实意义和实用价值。方法本研究利用文献分析法对影响新药研发项目的风险因素进行分类与筛选,构建风险因素集;运用问卷调查法了解调查对象关于风险因素对项目影响程度的认知,利用Kano模型双维度理念实现新药研发工作人员对风险因素管理认知,根据"风险因素管理与否对提高患者满意度是否有促进作用"确定风险因素是否需要进行有效管理,从风险管理成效角度进行风险分类定性评价研究;通过专家咨询法实现新药研发项目各个内控关键点的后果严重程度、可控程度调查,按照专家对各板块熟悉程度及判断依据的分值占总权威系数的比例设置权重,形成风险内控关键点严重性、可控性研究;风险属性分类及排序结果结合严重性与可控性分析,进行风险管理对策研究。内容本次研究从技术风险、财务风险、管理风险、环境风险、生产风险、市场风险六个角度划分新药研发项目中的风险因素,构建本次研究的风险因素集;研究Kano质量模型的定义及分类方法,转换为Kano二维风险属性模型,利用该模型双维度特性设计调查问卷,调查了解新药研发人员对"项目风险因素管理与否对提高患者满意度的影响"的看法,从风险管理成效维度对各风险因素进行Kano风险属性分类与排序,并从风险因素、风险类别、调查对象人口学差异三个方面分析比较风险因素对研发项目的影响程度;通过专家咨询法对风险内控关键点进行风险后果严重程度及可控程度的调查,按照专家对各板块熟悉程度及判断依据的分值占总权威系数的比例设置权重,完成风险内控关键点严重性与可控性研究;最后,根据识别出的新药研发项目风险的关键控制点,结合风险Kano属性分类及专家评分,提出新药研发项目风险应对措施。结果本研究将新药研发项目风险划分为技术风险、财务风险、管理风险、环境风险、生产风险和市场风险六大类,下设20项细分风险,形成新药研发项目风险因素集;基于Kano模型的问卷调查共计收集98份有效问卷,通过分析了解到,不同性别、职务级别的调查对象对20个风险因素影响度的认知均不具有统计学差异,P0.05,而在年龄、教育程度、工作年限三种分类情况下,对部分风险因素影响度的认知略有不同。利用Kano模型双维度理念进行药品研发人员对于项目风险管理的认知调查,将20项内控评价指标划分为5类Kano风险属性,其中必备属性风险9项,魅力属性风险9项,一维属性风险和逆反属性风险各1项,根据"必备属性魅力属性一维属性逆反属性"的风险应对优先顺序制定风险应对措施;邀请8位专家从风险后果严重程度和可控程度评价风险内控关键点的严重性及可控性,按照五级量化评分将风险内控关键点可控性划分为高可控性风险、中可控性风险、低可控性风险、极低可控性风险4个等级,并在风险对策研究中予以应用。结论本研究尝试将Kano质量模型引入风险管理研究领域,利用Kano模型属性特点进行新药研发项目风险分类,结合专家评分确定的风险后果严重度及风险可控性等级,实现了新药研发项目风险内控关键点管理对策研究。研究方法具有科学性、创新性和可行性,研究结果对于增强医风险药企业新药研发能力和风险内控能力、实现风险管理资源优化配置、满足消费者药品需求具有极强的现实意义和实用价值。在设计问卷条目时,应按照风险因素筛选原则保证调查内容的全面、精简和可操作;在选择调查对象时,基于本次研究的内容和目的,邀请权威程度高的专家进行严格打分,选择专业性强的药品研发专职人员开展Kano双维度问卷调查,以求提升研究结果的严谨性和专业性;此外,还需科学地选择适用的统计学方法进行数据处理和分析。
[Abstract]:Objective In view of the trend of overall risk management and internal control integration development, combining the necessity of new drug R & D project risk management and the feasibility of Kano's quality classification method in risk management research, this paper constructs a new drug R & D project risk factor set through literature research. Based on the definition and structure of the Kano quality model of the system, the classification and evaluation of risk factors based on the Kano risk attribute classification method are put forward, and the risk severity and controllable evaluation are realized by combining the drug R & D and risk management experts on the severity and controllable degree of the risk. Develop risk response measures to ensure the smooth development of risk control activities, promote the success of R & D projects, and realize the most effective risk control with the minimum management cost. The research results are of great practical significance and practical value to enhance the R & D ability and risk control ability of medical risk drug enterprises, to realize the optimal allocation of risk management resources and to meet the needs of consumers. Methods The risk factors influencing the R & D project of new drugs were classified and screened by the literature analysis method, and the risk factor set was constructed. Using the Kano model's double dimension idea to realize the cognition of risk factor management in new drug R & D staff, the risk factors need to be effectively managed according to the "Whether risk factor management plays a role in improving patient's satisfaction", and qualitative evaluation of risk classification is carried out from the perspective of risk management effectiveness. By means of expert consultation, the severity and controllability of the key points of risk control are formed according to the degree of familiarity of each plate and the proportion of the total authority coefficient according to the degree of familiarity and the judgment basis of the experts. Risk attribute classification and sequencing result combined severity and controllability analysis, carry on the risk management countermeasure research. In this study, the risk factors of the new drug R & D project are divided into six aspects: technical risk, financial risk, management risk, environmental risk, production risk and market risk, and the risk factor set of this study is constructed. The definition and classification method of the Kano quality model is studied. The method is converted into a Kano two-dimensional risk attribute model, and a questionnaire is designed by utilizing the two-dimensional characteristic design questionnaire of the model, the view of the new drug R & D personnel to the "The Influence of Risk Factors Management on Improving Patient Satisfaction" is investigated, the Kano risk attribute classification and the sorting are performed on the risk factors from the risk management effectiveness dimension, and the risk factors and the risk categories are selected. The influence degree of risk factors on R & D project is analyzed in three aspects of demographic difference of respondents, and the degree and degree of control of risk control key points are investigated by expert consultation method. according to the proportion setting weight of the experts on the familiarity degree and the judgment basis of each plate, and completing the research on the severity and controllability of the risk internal control key points; and finally, according to the identified key control points of the new drug R & D project risk, According to the classification of the risk Kano attribute and the expert's score, a new drug R & D project risk response measure is proposed. Results This study divided the R & D project risk into technical risk, financial risk, management risk, environmental risk, production risk and market risk. Based on the Kano model, a total of 98 effective questionnaires were collected. Through the analysis, it was found that there were no statistical differences in the influence degree of 20 risk factors among the subjects with different gender and job level, but in the case of age, education degree and service life, The cognition of the degree of influence of some risk factors is slightly different. According to the knowledge survey of the project risk management by the drug R & D personnel using the Kano model double dimension concept, 20 internal control evaluation indexes are classified into 5 Kano risk attributes, including 9 mandatory attribute risk, 9 charm attribute risk 9 items, one-dimensional attribute risk and one-dimensional attribute risk each item. The risk response measures shall be formulated according to the risk response of the "One-dimensional attribute inverse attribute of mandatory attribute charm attribute"; 8 experts shall be invited to evaluate the severity and controllability of risk control key points from the degree of severity and controllability of risk, and divide the controllability of risk internal control key points into high controllability risk according to the five-level quantitative score. Medium-controllable risk, low controllability risk, extremely low controllability risk 4 levels, and application in risk countermeasure research. Conclusion This study attempts to introduce the Kano quality model into the research field of risk management, make use of the characteristics of Kano model to carry on the classification of new drug R & D project risk, combine the risk degree and the degree of risk controllability determined by the expert's score, The research on management countermeasures of key points in the project risk control of new drug R & D project is realized. The research method is scientific, innovative and feasible, and the research results are of great practical significance and practical value to enhance the research and development ability and risk control ability of medical risk drug enterprises, to realize the optimal allocation of risk management resources and to meet the needs of consumers. When designing questionnaire items, the comprehensive, thin and operable survey contents shall be ensured according to the principle of risk factor screening; when selecting survey objects, experts with high authority shall be invited to carry out strict scoring based on the content and purpose of this study. Select professional drug R & D professionals to carry out the Kano double dimension questionnaire to improve the strictness and professionalism of the research results; besides, it is necessary to select the applicable statistical methods scientifically to carry out data processing and analysis.
【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R95

【参考文献】