The behavioural wedge

When nations fail to agree, can individual citizens make a difference? The third of our post-Copenhagen features is by Jonathan Gilligan, Thomas Dietz, Gerald T. Gardner, Paul C. Stern , and Michael P. Vandenbergh . They look at the effects that voluntary actions by individuals can have, and at the policies that can best encourage such actions.     

Time Series Models for Count or Qualitative Observations

Time series sometimes consist of count data in which the number of events occurring in a given time interval is recorded. Such data are necessarily nonnegative integers, and an assumption of a Poisson or negative binomial distribution is often appropriate. This article sets ups a model in which the level of the process generating the observations changes over time. A recursion analogous to the Kalman filter is used to construct the likelihood function and to make predictions of future observations. Qualitative variables, based on a binomial or multinomial distribution, may be handled in a similar way. The model for count data may be extended to include explanatory variables. This enables nonstochastic slope and seasonal components to be included in the model, as well as permitting intervention analysis. The techniques are illustrated with a number of applications, and an attempt is made to develop a model-selection strategy along the lines of that used for Gaussian structural time series models. The applications include an analysis of the results of international football matches played between England and Scotland and an assessment of the effect of the British seat-belt law on the drivers of light-goods vehicles.     

When the Learning Disabled Go to College

Abstract

During the last decade, federal laws have provided for remedial education in elementary and secondary schools for students with learning disabilities, preparing large numbers of them for college. Federal law also mandates helping learning-disabled students with their needs once they matriculate. Declining numbers of high school graduates in the aftermath of the baby boom have made more colleges open their doors to these students. The disabilities, and the accommodations they require, arrive in college with the rest of a student's baggage, demanding attention. Colleges and universities have chosen a variety of approaches, from specific remedial programs and individual accomodations according to need to more general programs. Some colleges pretend these disabilities do not exist and seem oblivious to their presence on campus. Learning disabilities can have an impact in every class and lecture hall and can contribute to unhappiness and the college's attrition rate. On the other hand, responsive and responsible programs provide students with the resources for the same education, honors, and opportunities as their nondisabled peers.     

Statistics in Latin America

Statistics is a relatively new discipline in Latin America. At present only sparse information is available about the state of the statistical profession in Latin America. We present and summarize the available information about the job market; training, education, and research; professional societies and their activities; and so forth. We also share our hopes, concerns, and suggestions for the future.     

A Quality Risk Management Model Approach for Cell Therapy Manufacturing

International regulatory authorities view risk management as an essential production need for the development of innovative, somatic cell‐based therapies in regenerative medicine. The available risk management guidelines, however, provide little guidance on specific risk analysis approaches and procedures applicable in clinical cell therapy manufacturing. This raises a number of problems. Cell manufacturing is a poorly automated process, prone to operator‐introduced variations, and affected by heterogeneity of the processed organs/tissues and lot‐dependent variability of reagent (e.g., collagenase) efficiency. In this study, the principal challenges faced in a cell‐based product manufacturing context (i.e., high dependence on human intervention and absence of reference standards for acceptable risk levels) are identified and addressed, and a risk management model approach applicable to manufacturing of cells for clinical use is described for the first time. The use of the heuristic and pseudo‐quantitative failure mode and effect analysis/failure mode and critical effect analysis risk analysis technique associated with direct estimation of severity, occurrence, and detection is, in this specific context, as effective as, but more efficient than, the analytic hierarchy process. Moreover, a severity/occurrence matrix and Pareto analysis can be successfully adopted to identify priority failure modes on which to act to mitigate risks. The application of this approach to clinical cell therapy manufacturing in regenerative medicine is also discussed.