Multiplicity: discussion points from the Statisticians in the Pharmaceutical Industry multiplicity expert group

In May 2012, the Committee of Health and Medicinal Products issued a concept paper on the need to review the points to consider document on multiplicity issues in clinical trials. In preparation for the release of the updated guidance document, Statisticians in the Pharmaceutical Industry held a one‐day expert group meeting in January 2013. Topics debated included multiplicity and the drug development process, the usefulness and limitations of newly developed strategies to deal with multiplicity, multiplicity issues arising from interim decisions and multiregional development, and the need for simultaneous confidence intervals (CIs) corresponding to multiple test procedures. A clear message from the meeting was that multiplicity adjustments need to be considered when the intention is to make a formal statement about efficacy or safety based on hypothesis tests. Statisticians have a key role when designing studies to assess what adjustment really means in the context of the research being conducted. More thought during the planning phase needs to be given to multiplicity adjustments for secondary endpoints given these are increasing in importance in differentiating products in the market place. No consensus was reached on the role of simultaneous CIs in the context of superiority trials. It was argued that unadjusted intervals should be employed as the primary purpose of the intervals is estimation, while the purpose of hypothesis testing is to formally establish an effect. The opposing view was that CIs should correspond to the test decision whenever possible. Copyright © 2013 John Wiley & Sons, Ltd.     

Euler(p,q) Processes and Their Application to Non Stationary Time Series with Time Varying Frequencies

We introduce Euler(p, q) processes as an extension of the Euler(p) processes for purposes of obtaining more parsimonious models for non stationary processes whose periodic behavior changes approximately linearly in time. The discrete Euler(p, q) models are a class of multiplicative stationary (M-stationary) processes and basic properties are derived. The relationship between continuous and discrete mixed Euler processes is shown. Fundamental to the theory and application of Euler(p, q) processes is a dual relationship between discrete Euler(p, q) processes and ARMA processes, which is established. The usefulness of Euler(p, q) processes is examined by comparing spectral estimation with that obtained by existing methods using both simulated and real data.     

Prioritizing Environmental Health Risks in the UAE

This article presents the results of a comparative environmental risk‐ranking exercise that was conducted in the United Arab Emirates (UAE) to inform a strategic planning process led by the Environment Agency‐Abu Dhabi (EAD). It represents the first national‐level application of a deliberative method for comparative risk ranking first published in this journal. The deliberative method involves a five‐stage process that includes quantitative risk assessment by experts and deliberations by groups of stakeholders. The project reported in this article considered 14 categories of environmental risks to health identified through discussions with EAD staff: ambient and indoor air pollution; drinking water contamination; coastal water pollution; soil and groundwater contamination; contamination of fruits, vegetables, and seafood; ambient noise; stratospheric ozone depletion; electromagnetic fields from power lines; health impacts from climate change; and exposure to hazardous substances in industrial, construction, and agricultural work environments. Results from workshops involving 73 stakeholders who met in five separate groups to rank these risks individually and collaboratively indicated strong consensus that outdoor and indoor air pollution are the highest priorities in the UAE. Each of the five groups rated these as being among the highest risks. All groups rated soil and groundwater contamination as being among the lowest risks. In surveys administered after the ranking exercises, participants indicated that the results of the process represented their concerns and approved of using the ranking results to inform policy decisions. The results ultimately shaped a strategic plan that is now being implemented.     

The roles of vertical and shared leadership in the enactment of executive corruption: Implications for research and practice

Recent scandals involving executive leadership have vaulted the topic of executive corruption to a central concern in the organizational literature. History suggests that power can corrupt and that absolute power can be an especially toxic influence. In this paper we propose that the propensity for corruption (as measured by CEO responsibility disposition) of leaders and the degree to which leadership is shared are key factors in understanding the potential for executive corruption. More specifically, shared leadership is proposed as a moderator that can deter corruptive tendencies by providing checks and balances capable of reducing the potential for corrupt behavior. A conceptual model is offered along with propositions to help guide future research and practice.     

Explaining Anomalous High Performance in a Health Care Supply Chain*

An implicit assumption in distributing and coordinating work among independent organizations in a supply chain is that a focal organization can use financial or contractual mechanisms to enforce compliance among the other organizations in meeting desired performance objectives. Absent contractual agreement or financial gain, there is little incentive for independent organizations to coordinate their process improvement activities. In this study, we examine a health care supply chain in which the work is distributed among independent organizations. We use a detailed case study and an abductive reasoning approach to understand how and why the independent organizations choose to coordinate and collaborate in their work. Our study makes two contributions to the literature. First, we use well‐established lean principles to explain how independent organizations achieve superior performance despite highly uncertain and variable customer demand—a context considerably different from the origins of lean principles. Second, we forward relational coordination theory to explain why the organizations in this decentralized supply chain coordinate their work. Relational coordination includes the use of shared goals, shared knowledge, and mutual respect for one another's work as primary mechanisms to explain process improvement in the absence of any contractual incentives. Our study constitutes a first step in generating theory for work design and its improvement in decentralized supply chains.     

MENTAL ILLNESS AND THE DEMAND FOR ALCOHOL, COCAINE, AND CIGARETTES

This article estimates the effect of mental illness on demand for addictive substances, allowing for structural endogeneity and simultaneity between mental illness and addictive consumption. Results show that individuals with a history of mental illness are 26% more likely to consume alcohol, 66% more likely to consume cocaine, and 89% more likely to consume cigarettes. This high-participation group is also price-responsive, although their price elasticities differ somewhat from those without mental illness. The results provide added justification for higher taxes and supply reduction activities. Furthermore, subsidizing the treatment of mental illness can reduce addictive consumption.(JEL I1 )