A note on sample size savings with the use of a single well‐controlled clinical trial to support the efficacy of a new drug

In terms of the risk of making a Type I error in evaluating a null hypothesis of equality, requiring two independent confirmatory trials with two‐sided p‐values less than 0.05 is equivalent to requiring one confirmatory trial with two‐sided p‐value less than 0.001 25. Furthermore, the use of a single confirmatory trial is gaining acceptability, with discussion in both ICH E9 and a CPMP Points to Consider document. Given the growing acceptance of this approach, this note provides a formula for the sample size savings that are obtained with the single clinical trial approach depending on the levels of Type I and Type II errors chosen. For two replicate trials each powered at 90%, which corresponds to a single larger trial powered at 81%, an approximate 19% reduction in total sample size is achieved with the single trial approach. Alternatively, a single trial with the same sample size as the total sample size from two smaller trials will have much greater power. For example, in the case where two trials are each powered at 90% for two‐sided α=0.05 yielding an overall power of 81%, a single trial using two‐sided α=0.001 25 would have 91% power. Copyright © 2004 John Wiley & Sons, Ltd.     

An Approach to Assessing the Impacts of Incident-Free Transportation of Radioactive Materials: II. Highway Transportation

Annual radiation doses and risks to the public living near, and traveling on, public highways, and occupational doses are calculated for highway shipments of radioactive materials under accident-free and incident-free conditions (i.e., under normal transportation conditions). The database developed by Sandia National Laboratories is used, and calculations are made using RADTRAN 4.0. This report is one of two reports estimating radiological risk associated with transportation of radioactive materials.     

Bayesian variable selection and regularization for time–frequency surface estimation

Summary.  We describe novel Bayesian models for time–frequency inverse modelling of non-stationary signals. These models are based on the idea of a Gabor regression , in which a time series is represented as a superposition of translated, modulated versions of a window function exhibiting good time–frequency concentration. As a necessary consequence, the resultant set of potential predictors is in general overcomplete—constituting a frame rather than a basis—and hence the resultant models require careful regularization through appropriate choices of variable selection schemes and prior distributions. We introduce prior specifications that are tailored to representative time series, and we develop effective Markov chain Monte Carlo methods for inference. To highlight the potential applications of such methods, we provide examples using two of the most distinctive time–frequency surfaces—speech and music signals—as well as standard test functions from the wavelet regression literature.     

Evaluating the Efficacy of a Mental Models Approach for Improving Occupational Chemical Risk Protection

Chemical risk protection in the workplace relies partly on informing workers about possible risks using material safety data sheets (MSDS). This article reports on phase 2 of a project (phase 1 reported in Cox et al.), which employed a mental models approach to improve on data sheets as communicative interventions for perchloroethylene in dry cleaning and rosin-based solder flux in the electronics industry within small businesses in the United Kingdom (small enterprises (SEs) < 25 employees in the workplace). It focuses on the efficacy of a multimethod evaluation strategy to assess (1) the capacity of a mental models approach to yield contextually relevant data for intervention design and (2) the effectiveness of the strategy itself in validating the mental models data. The evaluation was conducted using postal questionnaires and semi-structured verbal protocols to provide responses to the alternative intervention content and to prioritize risk messages. User discussion groups were then employed, particularly as a means of establishing whether contextual information could be obtained that would differ qualitatively from the kind elicited through individual (semi) structured methods. We conclude that the mental models approach as part of an iterative process including systematic multimethod evaluation is successful in supporting the design of relevant communications to the users of chemicals. The overall viability of communicative interventions in the context of health and safety in small businesses remains in question. Future research might aim to develop a more holistic approach to interventions in complex occupational contexts.     

Should I Stay or Should I Go? Explaining Turnover Intentions with Organizational Identification and Job Satisfaction*

The social identity approach is a powerful theoretical framework for the understanding of individuals' behaviour. The main argument is that individuals think and act on behalf of the group they belong to because this group membership adds to their social identity, which partly determines one's self‐esteem. In the organizational world, social identity and self‐categorization theories state that a strong organizational identification is associated with low turnover intentions. Because identification is the more general perception of shared fate between employee and organization, we propose that the relationship between identification and turnover will be mediated by job satisfaction as the more specific evaluation of one's task and working conditions. In four samples we found organizational identification feeding into job satisfaction, which in turn predicts turnover intentions.     

Wisdom of the crowd and capabilities of a few: internal success factors of crowdsourcing for innovation

Crowdsourcing has been demonstrated to be an effective strategy to enhance the efficiency of a firm’s innovation process. In this paper, we focus on tournament-based crowdsourcing (also referred to as “broadcast search”), a method to solve technical problems in form of an open call for solutions to a large network of experts. Based on a longitudinal study of six companies piloting this application of crowdsourcing, we identify barriers and sources of resistance that hinder its implementation in firms. Our paper contributes to the state of research by analyzing crowdsourcing on the level of pilot projects, hence providing a workflow perspective that considers the creation of dedicated processes and operations of crowdsourcing. This project level analysis enables the identification of specific challenges managers face when implementing crowdsourcing within an established R&D organization. Following a design science approach, we derive suggestions for organizational interventions to overcome these barriers. We find that dedicated promoter roles strongly contribute to a successful implementation of crowdsourcing, turning pilot projects into an organizational routine.     

Impact of Hazardous Substances Regulations on Small Firms in Delaware and New Jersey

Regulations under the 1990 Amendments to the Clean Air Act impose significant requirements on firms handling hazardous chemicals. The nature of the regulations would suggest that small firms, because of limited resources and other structural limitations, would experience more difficulty complying with the regulations than large firms. To understand the difficulties imposed by the regulations on small firms, we interviewed ten small firms in Delaware and New Jersey, states with existing hazardous regulations similar to those being considered by the U.S. Environmental Protection Agency, and evaluated their responses to state regulations. The impacts of the environmental regulations on the firms and on the risk levels of their businesses are discussed. Propositions for research into small firms compliance are developed. Possible means for reducing the regulatory burden on small firms while enhancing regulatory effectiveness are suggested.     

TRUST,SOCIAL CAPITAL,AND ECONOMIC DEVELOPMENT

Many argue that elements of a society's norms, culture, or social capital are central to understanding its development. However, these notions have been difficult to capture in economic models. Here we explore a possible role for “trustworthiness” as corresponding to social capital. Individuals are trustworthy when they perform in accordance with promises, even if this does not maximise their payoffs. The usual focus on incentive structures in motivating behaviour plays no role here. Instead, we emphasise more deep‐seated modes of behaviour and consider trustworthy agents being socialised to act as they do. To model this socialisation, we borrow from a process of preference evolution pioneered by Bisin and Verdier (2001). The model developed endogenously accounts for social capital and explores its role in the process of economic development. It captures in a simple, formal way the interaction between social capital and the economy's productive processes. The results obtained caution against rapid reform and provide an explanation for why late‐developing countries may not easily be able to transplant the modes of production that have proved useful in the West. (JEL: O1, O3, O4, Z1)