A review and validation of overall survival extrapolation in health technology assessments of cancer immunotherapy by the National Institute for Health and Care Excellence: how did the initial best estimate compare to trial data subsequently made available?

Background: Validation of overall survival (OS) extrapolations of immune-checkpoint inhibitors (ICIs) during the National Institute for Health and Care Excellence (NICE) Single Technology Assessment (STA) process is limited due to data still maturing at the time of submission. Inaccurate extrapolation may lead to inappropriate decision-making. The availability of more mature trial data facilitates a retrospective analysis of the plausibility and validity of initial extrapolations. This study compares these extrapolations to subsequently available longer-term data.

Methods: A systematic search of completed NICE appraisals of ICIs from March 2000 to December 2017 was performed. A targeted search was also undertaken to procure published OS data from the pivotal clinical trials for each identified STA made available post-submission to NICE. Initial Kaplan-Meier curves and associated extrapolations from NICE documentation were extracted to compare the accuracy of OS projections versus the most mature data.

Results: The review identified 11 STAs, of which 10 provided OS data upon submission to NICE. The extrapolations undertaken considered parametric or piecewise survival models. Additional data cut-offs provided a mean of 18 months of OS beyond the end of the original data. Initial extrapolations typically under-estimated OS from the most mature data cut-off by 0.4–2.7%, depending on the choice of assessment method and use of the manufacturer- or ERG-preferred extrapolation.

Conclusion: Long-term extrapolation of OS is required for NICE STAs based on initial immature OS data. The results of this study demonstrate that the initial OS extrapolations employed by manufacturers and ERGs generally predicted OS reasonably well when compared to more mature data (when available), although on average they appeared to underestimate OS. This review and validation shows that, while the choice of OS extrapolation is uncertain, the methods adopted are generally aligned with later-published follow-up data and appear appropriate for informing HTA decisions.     

国家综合配套改革区与制度的空间演化分析

建立国家综合配套改革试验区,不仅是为了促进滨海新区及天津市的发展,更重要的是推动环渤海地区,乃至整个北方地区的发展,形成新的区域发展模式。这就要求在理论上不仅要考虑到技术、制度的因素,也要考虑到空间的因素对国家综合配套改革试验区理论模型的影响。具体研究空间因素对国家综合配套改革试验区的影响有助于准确理解和把握国家综合配套改革试验区的空间作用,形成新的区域增长方式和区域发展模式,为在全国范围内贯彻科学发展观和构建和谐社会提供崭新的思路和视角。     

财务管理专业《内部控制学》课程的教学改革方案设计

在我国当前内部控制的教学模式相对落后、教学改革几乎空白的背景下,本文以四川师范大学商学院财务管理专业为依托,针对《内部控制学》课程的教学内容制定了“实践模拟教学体系”,为保证教学目标的实现构建了“组合式教学法”.灵活多样的教学方法相互融合且交替使用于不同的教学内容中,由此设计出一套完整严密的教学改革总体方案.     

Key drivers of passengers' overall satisfaction at klia2 terminal

The purpose of this study is to examine the airport service quality dimensions based on the ASQ survey and investigate the best predictor for overall satisfaction. The context of this study is the klia2 terminal passengers, which are predominantly users of the low-cost carriers at Kuala Lumpur International Airport. Secondary data obtained from the airport operator on the 2016 ASQ survey for the klia2 terminal was analysed using the PLS-SEM method. The grouping and impact of the thirty-three service quality elements from the ASQ survey were tested against the overall satisfaction element. The findings indicated that twenty-two out of the thirty-three elements were valid measures for the klia2 terminal users which forms the eight dimensions i.e. access, airport environment, airport facilities, arrival services, check-in, finding your way, passport and security. Airport environment was found as the best predictor in determining passengers’ overall satisfaction at klia2 terminal and should be given particular focus by the airport operator for continuous improvements.     

The relationships among overall quick-casual restaurant image,perceived value,customer satisfaction,and behavioral intentions

The purpose of this research is to explain the relationships among overall quick-casual restaurant image, perceived value, customer satisfaction, and behavioral intentions in the quick-casual restaurant industry. The findings indicate that overall quick-casual restaurant image significantly influences perceived value, and overall quick-casual restaurant image and perceived value had a significant role in influencing customer satisfaction. Additionally, overall quick-casual restaurant image, perceived value, and customer satisfaction are significant predictors of customers’ behavioral intentions. Finally, customer satisfaction can act as a partial mediator in the relationship between overall quick-casual restaurant image/perceived value and behavioral intentions. Furthermore, we discuss the theoretical and managerial implications of the findings and future research ideas.     

“五个统筹“与国家制度创新的辩证分析

"五个统筹"是中共中央根据我国当前经济社会发展中存在的主要矛盾提出来的今后中国改革发展的总的要求,是辩证唯物主义的发展观.这一发展观的贯彻实施的关键在于国家制度的创新.     

提高思想道德修养与法律基础课教学质量的几点思考

2006年秋季，在全国普通高校全面开设思想道德修养与法律基础课（以下简称“基础”课），这标志着高校思想政治理论课新课程方案的实施工作取得重大进展。本文在分析提高“基础”课教学质量重要意义的基础之上，系统阐述了提高“基础”课教学质量的总体理念及科学方法。     

房地产开发企业资金运行机理及风险控制研究

房地产开发企业作为市场主体,从事的是典型的资金密集型产业生产,因而存在具有高风险运行性质的企业资金链,同时作为典型项目型企业,通常还包括多条相对独立的项目资金链,是由相互作用来共同影响企业的运营和发展。本文对资金链的内在运行机理进行了剖析,对其运行风险及影响因素进行了分析并提出了相应的防控措施,以期为房地产企业资金链的安全和稳健运行提供参考。     

新疆工业支柱产业选择的实证分析

在经济发展的任何时期,持续发展的动力都来源于一组支柱产业的带动和刺激。本文从静态和动态两个角度构建工业支柱产业的选择模式,以此对新疆工业支柱产业进行实证分析,最终选出石油及天然气开采业等六个产业作为新疆工业的支柱产业。     

基于组织生态理论的企业全面预算管理

价值最大化导向的企业全面预算没有完全考虑到生态资源的稀缺性,以牺牲生态资源实现企业价值最大。立足于企业生态足迹的生态全面预算是在企业生态足迹最小的条件下实现企业价值最大,主要由价值作业预算模块、生态预算模块与耦合预算模块组成,耦合预算是价值预算与生态预算协调预算。为了减少生态预算的执行难度,保证生态全面预算的实施与应用,须同时转变管理观念、完善管理信息系统与配套三维绩效评价制度。