Issues in applying recent CPMP ‘Points to Consider’ and FDA guidance documents with biostatistical implications

The International Conference on Harmonisation guideline ‘Statistical Principles for Clinical Trials’ was adopted by the Committee for Proprietary Medicinal Products (CPMP) in March 1998, and consequently is operational in Europe. Since then more detailed guidance on selected topics has been issued by the CPMP in the form of ‘Points to Consider’ documents. The intent of these was to give guidance particularly to non‐statistical reviewers within regulatory authorities, although of course they also provide a good source of information for pharmaceutical industry statisticians. In addition, the Food and Drug Administration has recently issued a draft guideline on data monitoring committees. In November 2002 a one‐day discussion forum was held in London by Statisticians in the Pharmaceutical Industry (PSI). The aim of the meeting was to discuss how statisticians were responding to some of the issues covered in these new guidelines, and to document consensus views where they existed. The forum was attended by industry, academic and regulatory statisticians. This paper outlines the questions raised, resulting discussions and consensus views reached. It is clear from the guidelines and discussions at the workshop that the statistical analysis strategy must be planned during the design phase of a clinical trial and carefully documented. Once the study is complete the analysis strategy should be thoughtfully executed and the findings reported. Copyright © 2003 John Wiley & Sons, Ltd.     

Fit and Skill in Employee Selection: Insights from a Study of Headhunters

We draw upon evidence from a qualitative study of headhunters to provide insights into the character and importance of candidate fit and skill for the selection of a broad range of white-collar employees. Headhunters suggest that the fit of a job candidate is assessed at two levels, one corresponding with a general compatibility with organization-level norms, culture, and strategy, the other corresponding more closely with traits and characteristics of the person or persons with whom the job candidate actually interviews. Skill—a factor which is largely neglected by those who tout the importance of fit—also plays an important and independent role in employee selection. Stalls that influence the selection of employees from a pool of candidates tend to be highly specific if not idiosyncratic, and take the form of what headhunters call hot buttons. We conclude by discussing the conceptualization, causes, and implications of fit; we also consider how the importance of fit and hot buttons challenges the explanatory logic of standard accounts of labor-market success.     

A Comparison of Ambient Casino Sound and Music: Effects on Dissociation and on Perceptions of Elapsed Time While Playing Slot Machines

This research examined the effects of a casino’s auditory character on estimates of elapsed time while gambling. More specifically, this study varied whether the sound heard while gambling was ambient casino sound alone or ambient casino sound accompanied by music. The tempo and volume of both the music and ambient sound were varied to manipulate temporal engagement and introspection. One hundred and sixty (males = 91) individuals played slot machines in groups of 5–8, after which they provided estimates of elapsed time. The findings showed that the typical ambient casino auditive environment, which characterizes the majority of gaming venues, promotes understated estimates of elapsed duration of play. In contrast, when music is introduced into the ambient casino environment, it appears to provide a cue of interval from which players can more accurately reconstruct elapsed duration of play. This is particularly the case when the tempo of the music is slow and the volume is high. Moreover, the confidence with which time estimates are held (as reflected by latency of response) is higher in an auditive environment with music than in an environment that is comprised of ambient casino sounds alone. Implications for casino management are discussed.     

Risk of Disclosure, Perceptions of Risk, and Concerns about Privacy and Confidentiality as Factors in Survey Participation

This article reports on a web-based vignette experiment investigating how likely subjects would be to participate in surveys varying in topic sensitivity and risk of disclosure. A total of 3,672 participants each responded to a series of eight vignettes, along with a variety of background questions, concerns about confidentiality, trust in various institutions, and the like.Vignettes were randomly assigned to respondents, such that each respondent was exposed to four levels of disclosure risk for each level of topic sensitivity (high versus low). Half the sample was assigned to receive a confidentiality statement for all eight vignettes, while the other half received no mention of confidentiality in the vignettes. The order of presentation of vignettes was randomized for each respondent.Respondents were also asked for their subjective perceptions of risk, harm, and social as well as personal benefits for one of the eight vignettes. Adding these questions permits us to examine how objective risk information presented by the researcher relates to the subjective perception of risk by the participant, and to assess the importance of both for their willingness to participate in the surveys described.Under conditions resembling those of real surveys, objective risk information does not affect willingness to participate. On the other hand, topic sensitivity does have such effects, as do general attitudes toward privacy and survey organizations as well as subjective perceptions of risk, harm, and benefits. We discuss the limitations and implications of these findings.     

Evidence for improved sensitivity of within-participants analyses in tests of the theory of reasoned action

Two studies involving 26 behaviors were performed to test four hypotheses. Between-participants and within-participants analyses of attitudes, subjective norms, behavioral intentions and actual behaviors suggested the following conclusions. First, consistent with Trafimow and Finlay (1996), the prediction of intentions from attitudes and subjective norms is better when within-participants analyses than between-participants analyses are used. Second, behavioral intentions are a good predictor of actual behavior, regardless of whether between-participants or within-participants analyses are used. Third, attitudes can predict unique variance in behaviors even when controlling for intentions, but it takes within-participants analyses to detect the effect. Fourth, subjective norms can predict unique variance in behaviors even when controlling for intentions, but it takes within-participants analyses to detect the effect. We conclude that within-participants analyses should be used for more sensitive tests of the theory of reasoned action.     

Eye-Tracking Data: New Insights on Response Order Effects and Other Cognitive Shortcuts in Survey Responding

Survey researchers since Cannell have worried that respondents may take various shortcuts to reduce the effort needed to complete a survey. The evidence for such shortcuts is often indirect. For instance, preferences for earlier versus later response options have been interpreted as evidence that respondents do not read beyond the first few options. This is really only a hypothesis, however, that is not supported by direct evidence regarding the allocation of respondent attention. In the current study, we used a new method to more directly observe what respondents do and do not look at by recording their eye movements while they answered questions in a Web survey. The eye-tracking data indicate that respondents do in fact spend more time looking at the first few options in a list of response options than those at the end of the list; this helps explain their tendency to select the options presented first regardless of their content. In addition, the eye-tracking data reveal that respondents are reluctant to invest effort in reading definitions of survey concepts that are only a mouse click away or paying attention to initially hidden response options. It is clear from the eye-tracking data that some respondents are more prone to these and other cognitive shortcuts than others, providing relatively direct evidence for what had been suspected based on more conventional measures.     

The relation of gender and sexual orientation to measures of masculinity, femininity, and androgyny: a further analysis

Data from a survey of 58 gay men and 58 lesbians are compared to college men and women on Spence and Helmreich's (1978) Personality Attributes Questionnaire measures of masculinity, femininity, and androgyny. Lesbians had higher M scores than college women, and gay men had lower M scores than college men, with F scores being similar across sexual orientation groups, within gender. Androgyny measures differed only by gender, not by sexual orientation. Further analysis shows that lesbians' high M scores come largely from their high self-ratings as independent, while college men's high M scores reflect strong competitiveness. Questions are raised about the validity of these measures for comparing these groups.