Richard Kay – författare

Never before had France had a church council so large: almost 1000 churchmen assembled at Bourges on 29 November 1225 to authorize a tax on their incomes in support of the Second Albigensian Crusade. About one third of the participants were representatives sent by corporate bodies, in accordance with a new provision of canon law that insisted, for the first time ever, that there should be no taxation without representation. Basing himself on the rich surviving records, Professor Kay paints a skilful portrait of this council: the political manoeuvering by the papal legate to ensure the tax went through, and his use of this highly public occasion to humiliate members of the University of Paris; and, on the other hand, his failure to win a permanent endowment to support the papal bureaucracy, the bishops' effective protests against the pope's threat to diminish their jurisdiction over monasteries, and a subsequent 'taxpayers' revolt' that challenged the validity of the tax. The book also draws out the importance and implications of what took place, highlighting the council's place at the fountainhead of European representative democracy, the impact of the decisions made on the course of the Albigensian Crusade, the reform of monasticism, and the funding of the papal government which was left to rely on stop-gap expedients, such as the sale of indulgences. In addition, the author suggests that the corpus of texts, newly edited from the original manuscripts and with English translation, could be seen as a model for the revision of the conciliar corpus, most of which still remains based on 18th-century scholarship.

This book is a volume in the Penn Press Anniversary Collection. To mark its 125th anniversary in 2015, the University of Pennsylvania Press rereleased more than 1,100 titles from Penn Press's distinguished backlist from 1899-1999 that had fallen out of print. Spanning an entire century, the Anniversary Collection offers peer-reviewed scholarship in a wide range of subject areas.

STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATIONStatistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices.Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance. The author’s years of experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential guide for the those working in and with the industry.The third edition of Statistical Thinking for Non-Statisticians in Drug Regulation includes: A detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9Major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-AnalysisUpdated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experienceStatistical Thinking for Non-Statisticians in Drug Regulation is a valuable guide for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development.