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.     

Verbal and nonverbal communication of warmth to children,foreigners, and retarded adults

The verbal and nonverbal communication of warmth was examined in a study in which undergraduate women taught a block design task to a listener who was either a six-year-old child, a retarded adult, a peer who spoke English as a second language (foreigner), or a peer who was a native speaker of English. The degree of warmth conveyed by the speakers differed only minimally across different categories of listeners. However, these communications did vary systematically within each category, in accord with the levels of cognitive and linguistic sophistication of each particular listener. Speakers tended to fine-tune communications by conveying more warmth to the more sophisticated children and foreigners than to the less sophisticated members of these categories. To the more sophisticated retarded persons, however, they conveyed—nonverbally—less warmth than to the less sophisticated retarded persons. The relevance of these findings to the communication of expectancy effects and to the social psychology of stigma is discussed.This paper was written while the first author was visiting at the University of Florida. We thank John Neil Bohannon, Linda Caporael, Margaret Clark, William Cooper, Monica Harris, Harry Levin, and Carol Sigelman for their helpful comments on an earlier draft of this paper. For their help in conducting this research, we thank Ann Ashworth, Pamela Brown, Linda Douglas, Susan Finkelstein, Tamara Harper, Robin Johnson, Susan Kirdendol, Sheila Larkin, Sue Limber, Jose Macaranas, Ashook Nimgade, Maria Papetti, Maurice Perry, Lester Pretlow, Carissa Smith, Laura Taswell, Tina Tedeschi, Charles Valadez, and all of our listener-subjects. We also thank the students, faculty, and administration of Dunmore High School, Dunmore, Pennslyvania, for their participation and cooperation. Support from NSF, NIMH, the National Academy of Education, and a Rackham Faculty Grant was invaluable. Most importantly, we thank Roger Brown and Robert Rosenthal for their wisdom and inspiration.     

International migration: demographic and socioeconomic consequences in the United Kingdom and Europe

"This article evaluates the consequences of international migration since World War II, with particular reference to Great Britain. It emphasizes the substantial differences between the origins and responses to immigration in the United Kingdom and that of the rest of Western Europe." It is found that "people of non-European origin from Commonwealth countries have predominated in postwar immigration to the United Kingdom. That migration neutralized the previously dominant pattern of emigration and increased U.K. population by about 3 million people through immigration and higher fertility, with only slight effects upon the age distribution."     

The design of organizations and the right to act

Recent innovations in the structure of formal organizations suggest possible directions for the design of schools to bring about high achievement. The structure of output-driven in contrast to administratively-driven schools is described, and designs are described which address both the goal of high achievement and the goal of reduced inequality.An earlier version of this paper was presented as the author's Sorokin Lecture at the annual meeting of the Eastern Sociological Society, Boston, March 1993.     

College students’ attitudes toward abortion and commitment to the issue

Male and female participants were surveyed on abortion attitudes, commitment, and abortion experience. Results revealed a normal distribution of abortion attitudes rejecting the notion that the vast majority of the sample would have significantly pro-choice views. No significant difference was found in overall abortion attitudes of males vs. females, however, individuals with direct abortion experience were found to have significantly stronger pro-choice attitudes than individuals without direct abortion experience. Overall, college students reported a moderate degree of commitment to the issue of abortion. Females were significantly more committed than males, individuals with direct abortion experience were significantly more committed than individuals without direct abortion experience, and individuals with more extreme abortion attitudes were significantly more committed than those with weaker, more ambivalent, attitudes. No significant difference was found in level of commitment between pro-choice and pro-life individuals.