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Stephen J. Ruberg Frank E. Harrell Jr. Margaret Gamalo-Siebers Lisa LaVange J. Jack Lee Karen Price 《The American statistician》2019,73(1):319-327
ABSTRACTThe cost and time of pharmaceutical drug development continue to grow at rates that many say are unsustainable. These trends have enormous impact on what treatments get to patients, when they get them and how they are used. The statistical framework for supporting decisions in regulated clinical development of new medicines has followed a traditional path of frequentist methodology. Trials using hypothesis tests of “no treatment effect” are done routinely, and the p-value < 0.05 is often the determinant of what constitutes a “successful” trial. Many drugs fail in clinical development, adding to the cost of new medicines, and some evidence points blame at the deficiencies of the frequentist paradigm. An unknown number effective medicines may have been abandoned because trials were declared “unsuccessful” due to a p-value exceeding 0.05. Recently, the Bayesian paradigm has shown utility in the clinical drug development process for its probability-based inference. We argue for a Bayesian approach that employs data from other trials as a “prior” for Phase 3 trials so that synthesized evidence across trials can be utilized to compute probability statements that are valuable for understanding the magnitude of treatment effect. Such a Bayesian paradigm provides a promising framework for improving statistical inference and regulatory decision making. 相似文献
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The theory of incapacitation involves reducing an offender's ability or capacity to commit further crimes. Capital punishment accomplishes this goal. An executed murderer never murders again. However, we do not execute all murderers, only capital murderers. This policy produces several research questions. Do capital murderers present a special risk to society? Are capital murderers more likely to murder or commit other violent crimes again than other murderers or the average citizen? To answer these questions, many states require a prediction of future dangerousness of a newly convicted murderer. To what extent has the judgment of future dangerousness matched actuarial data of subsequent murders and serious crimes? Using a secondary analysis, this investigation attempted to assemble available data of postconviction dangerousness of death sentenced capital murderers to create a more comprehensive actuarial account of subsequent dangerousness and to present the data in a common format used by the Federal Bureau of Investigation and the Bureau of Justice Statistics. Across 14 studies identified with relevant data, there were 13 instances of subsequent murder and 462 serious crime or prison rule violations. 相似文献
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Older disabled workers' perceptions of volunteering 总被引:1,自引:0,他引:1
Susan Balandin Gwynnyth Llewellyn Angela Dew Liora Ballin Julie Schneider 《Disability & Society》2006,21(7):677-692
The activity of volunteering is readily available to, and undertaken by, able-bodied people in Australia and is recognized as a valuable social pursuit, particularly among citizens of retirement age. Despite the known benefits of volunteering, however, there are few reports of disabled people participating as volunteers and little is understood of their experiences or perceptions of volunteering. The aim of this study was to explore how older workers within supported employment settings perceived the opportunities for and barriers to volunteering. Fourteen people with long-standing impairments participated in this small qualitative study. Overall the participants were positive about volunteering, but noted they might require support to volunteer successfully. Drawing upon the participants' views, recommendations are made for developing training. Disabled workers facing retirement need to be supported to have opportunities for active participation in the community as volunteers if so desired. 相似文献
5.
Casey Crump Kenny Crump Eric Hack Rose Luippold Kenneth Mundt Elizabeth Liebig Julie Panko Dennis Paustenbach Deborah Proctor 《Risk analysis》2003,23(6):1147-1163
This study evaluates the dose-response relationship for inhalation exposure to hexavalent chromium [Cr(VI)] and lung cancer mortality for workers of a chromate production facility, and provides estimates of the carcinogenic potency. The data were analyzed using relative risk and additive risk dose-response models implemented with both Poisson and Cox regression. Potential confounding by birth cohort and smoking prevalence were also assessed. Lifetime cumulative exposure and highest monthly exposure were the dose metrics evaluated. The estimated lifetime additional risk of lung cancer mortality associated with 45 years of occupational exposure to 1 microg/m3 Cr(VI) (occupational exposure unit risk) was 0.00205 (90%CI: 0.00134, 0.00291) for the relative risk model and 0.00216 (90%CI: 0.00143, 0.00302) for the additive risk model assuming a linear dose response for cumulative exposure with a five-year lag. Extrapolating these findings to a continuous (e.g., environmental) exposure scenario yielded an environmental unit risk of 0.00978 (90%CI: 0.00640, 0.0138) for the relative risk model [e.g., a cancer slope factor of 34 (mg/kg-day)-1] and 0.0125 (90%CI: 0.00833, 0.0175) for the additive risk model. The relative risk model is preferred because it is more consistent with the expected trend for lung cancer risk with age. Based on statistical tests for exposure-related trend, there was no statistically significant increased lung cancer risk below lifetime cumulative occupational exposures of 1.0 mg-yr/m3, and no excess risk for workers whose highest average monthly exposure did not exceed the current Permissible Exposure Limit (52 microg/m3). It is acknowledged that this study had limited power to detect increases at these low exposure levels. These cancer potency estimates are comparable to those developed by U.S. regulatory agencies and should be useful for assessing the potential cancer hazard associated with inhaled Cr(VI). 相似文献
6.
Julie Sweetland 《Journal of Sociolinguistics》2002,6(4):514-538
Recent work on language crossing in the U.S. has examined the temporary appropriation of African American Vernacular English by white youth in an effort to participate in the current popularity and prestige of hip–hop culture, or in order to highlight racial boundaries. While such verbal behavior probably encompasses most white use of AAVE, it is not the only way in which whites (or other non–blacks) can use the variety. This paper presents a case study of the language of a 23 year old white female who makes consistent use of many distinctive linguistic features associated with AAVE. I argue that the interaction of ideologies of race, class, localness and language allow her to be considered an ingroup member despite her biographical race. This suggests that there is a tension between academic linguistic theory and actual speaker practice in assigning authenticity to individuals, and I conclude that language ideologies and other forms of qualitative evidence should be taken into account by sociolinguists looking at the link between language and race. 相似文献
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Toddlers' knowledge of the stereotyping of traditionally feminine and masculine household activities was examined using the preferential looking paradigm. Seventy‐seven 24‐month‐old infants observed a series of 9 pairs of photographs, each portraying a male and female adult engaged in the same stereotyped or gender‐neutral activity (e.g., ironing, hammering, or reading). Longer looking times were predicted on stimuli inconsistent with gender stereotypes (e.g., looking longer at the man putting on lipstick than at the woman). The results suggested that toddlers have acquired some knowledge of the gender stereotyping of feminine activities by their 2nd birthday. 相似文献
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10.
Alan J. Fridlund John P. Sabini Laura E. Hedlund Julie A. Schaut Joel I. Shenker Matthew J. Knauer 《Journal of Nonverbal Behavior》1990,14(2):113-137
Subjects imagined situations in which they reported enjoying themselves either alone or with others. Electromyographic (EMG) activity was recorded bilaterally from regions overlying thezygomatic major muscles responsible for smiling. Controlling for equal rated happiness in the two conditions, subjects showed more smiling in high-sociality than low-sociality imagery. In confirming imaginary audience effects during imagery, these data corroborate hypotheses that solitary facial displays are mediated by the presence of imaginary interactants, and suggest caution in employing them as measures of felt emotion.Avery Gilbert and Amy Jaffey had compelling insights throughout the course of study. We thank Paul Ekman, Carroll Izard, and Paul Rozin for extensive comments on earlier drafts. We also thank Bernard Apfelbaum, Jon Baron, Janet Bavelas, John Cacioppo, Linda Camras, Dean Delis, Rob DeRubeis, Alan Fiske, Stephen Fowler, Greg McHugo, Harriet Oster, David Premack, W. John Smith, and David Williams for their valuable comments and suggestions. 相似文献