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. 相似文献
We evaluate the usefulness of the Hodrick-Prescott (HP) filter as a proxy for rational expectations, using long runs of annual
US inflation data. Our conclusion is that while the HP series are not fully rational in the sense of Muth (1961), they do
generally meet the criterion of `weak rationality' recently proposed by Grant and Thomas (1999). They are also rational proxy
predictors of direction for, following Merton (1981), agents would not change their prior in the opposite direction to these
`forecasts'. However, smoother HP `forecasts' are more prone to inefficiency and less useful predictors of direction.
First Version Received: May 2000/Final Version Received: May 2001 相似文献
In this paper we examine the long-term performance of publicly traded firms that issue straight debt, convertible debt, or common stock. Declines in firm performance following issuance are consistent with declines in firm value at announcement and issuance, and suggest that convertible debt and common stock are substantially equivalent. This study is consistent with the pecking-order and Miller-Rock models, but inconsistent with the leverage-signaling model. Despite a significant decline following issuance, firms issuing common stock or convertible debt perform better, on average, than the industry before, at, and after issuance. This is consistent with younger, riskier, higher-growth firms being the predominant issuers of common stock and convertible debt. 相似文献
Managerial decisions regarding timing of inventory replenishment are as important as determining the economic order size in inventory management. Yet most of the introductory texts on cost/managerial accounting and production/operations management do not adequately discuss reorder point determination, especially the condition on lead time demand that is necessary for valid application of the commonly reported formula for the reorder point. A clear understanding of the reorder point determination is important to students, teachers, and practicing managers alike. This note attempts to explain the underlying condition and modification needed in the reorder point formula. 相似文献
We examine the decision to prepay a fixed‐rate mortgage in the United Kingdom, Canada, Ireland, Australia and New Zealand. These countries are characterized by having substantial fees which are associated with breaking a fixed‐rate mortgage. We develop a model which allows for fluctuations both in banks’ wholesale rates and credit spreads. We find that households can achieve economically significant benefits both from following an optimal prepayment strategy contingent on the break fee used by their bank and also by selection of fixed interest rate term and (where available) break fee structure. 相似文献
Researchers have suggested that ethical judgments about “right” and “wrong” are the result of deep and thoughtful principles and should therefore be consistent and not influenced by factors, such as language (Costa et al. in PLoS ONE 9(4):e94842, 2014b, p. 1). As long as an ethical scenario is understood, individuals’ resolution should not depend on whether the ethical scenario is presented in their native language or in a foreign language. Given the forces of globalization and international convergence, an increasing number of accountants and accounting students are becoming proficient in more than one language, and they are required to interpret and apply complex ethical pronouncements issued by various global standard setters both in their native language and in English. There have been calls in the literature to examine whether subjects make systematically different ethical judgments in a foreign language than in their native language. We contribute to the literature by drawing on culture, linguistics, and psychology research to provide empirical evidence that Chinese subjects are more aggressive in interpreting the concept of control when providing their consolidation reporting recommendations in English than in Simplified Chinese. We applied a 2 × 2 within-subject and between-subject randomized experimental design using a sample of Chinese final year undergraduate accounting students at a leading Chinese university, where accounting courses are taught in both Simplified Chinese and English. Students in our study are proxy for entry-level accounting practitioners. Our findings have implications for the globalized business world and cross-cultural research by challenging the commonly held assumption that an individual’s ethical judgment is consistent in different languages. We suggest that systematically different ethical judgments in native and foreign languages needs to be recognized. 相似文献