Clinical trials [[electronic resource] ] : a methodologic perspective / / Steven Piantadosi

• Record Nr.: UNINA9910830504303321
• Autore: Piantadosi Steven
• Pubbl/distr/stampa: Hoboken, N.J., : Wiley-Interscience, c2005
• ISBN: 1-280-27719-X; 9786610277193; 0-470-35561-1; 0-471-74013-6; 0-471-72781-4
• Edizione: [2nd ed.]
• Descrizione fisica: 1 online resource (717 p.)
• Collana: Wiley series in probability and statistics
• Disciplina: 610/.72; 615.50724
• Soggetti: Clinical trials - Statistical methods
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references (p. 613-658 ) and indexes.
• Nota di contenuto: CLINICAL TRIALS; CONTENTS; Preface; Preface to the First Edition; 1 Preliminaries; 1.1 Introduction; 1.2 Audience and Scope; 1.3 Other Sources of Knowledge; 1.3.1 Terminology; 1.3.2 Review of Notation and Terminology Is Helpful; 1.4 Examples, Data, and Programs; 1.5 Summary; 2 Clinical Trials as Research; 2.1 Introduction; 2.1.1 Clinical Reasoning Is Based on the Case History; 2.1.2 Statistical Reasoning Emphasizes Inference Based on Designed Data Production; 2.1.3 Clinical and Statistical Reasoning Converge in Research; 2.2 Defining Clinical Trials Formally; 2.2.1 Mixing of Clinical and Statistical Reasoning Is Recent2.2.2 Clinical Trials Are Rigorously Defined; 2.2.3 Experiments Can Be Misunderstood; 2.2.4 Clinical Trials as Science; 2.2.5 Trials and Statistical Methods Fit within a Spectrum of Clinical Research; 2.3 Practicalities of Usage; 2.3.1 Predicates for a Trial; 2.3.2 Trials Can Provide Confirmatory Evidence; 2.3.3 Clinical Trials Are Unwieldy, Messy, and Reliable; 2.3.4 Other Methods Are Valid for Making Some Clinical Inferences; 2.3.5 Trials Are Difficult to Apply in Some Circumstances; 2.3.6 Randomized Studies Can Be Initiated Early; 2.4 Summary2.5 Questions for Discussion; 3 Why Clinical Trials Are Ethical; 3.1 Introduction; 3.1.1 Science and Ethics Share Objectives; 3.1.2 Equipoise and Uncertainty; 3.2 Duality; 3.2.1 Clinical Trials Sharpen, but Do Not Create, the Issue; 3.2.2 A Gene Therapy Tragedy Illustrates Duality; 3.2.3 Research and Practice Are Convergent; 3.2.4 The Hippocratic Tradition Does Not Proscribe Clinical Trials; 3.2.5 Physicians Always Have Multiple Roles; 3.3 Historically Derived Principles of Ethics; 3.3.1 Nuremberg Contributed an Awareness of the Worst Problems; 3.3.2 High-Profile Mistakes Were Made in the United States3.3.3 The Helsinki Declaration Was Widely Adopted; 3.3.4 Other International Guidelines Have Been Proposed; 3.3.5 Institutional Review Boards Provide Ethical Oversight; 3.3.6 Ethical Principles Relevant to Clinical Trials; 3.4 Contemporary Foundational Principles; 3.4.1 Collaborative Partnership; 3.4.2 Scientific Value; 3.4.3 Scientific Validity; 3.4.4 Fair Subject Selection; 3.4.5 Favorable Risk-Benefit; 3.4.6 Independent Review; 3.4.7 Informed Consent; 3.4.8 Respect for Subjects; 3.5 Methodologic Reflections; 3.5.1 Practice Based on Unproven Treatments Is Not Ethical3.5.2 Ethics Considerations Are Important Determinants of Design; 3.5.3 Specific Methods Have Justification; 3.6 Professional Conduct; 3.6.1 Conflict of Interest; 3.6.2 Professional Statistical Ethics; 3.7 Summary; 3.8 Questions for Discussion; 4 Contexts for Clinical Trials; 4.1 Introduction; 4.1.1 Some Ways to Learn about Trials in a Given Context; 4.1.2 Issues of Context; 4.2 Drugs; 4.2.1 Are Drugs Special?; 4.2.2 Why Trials Are Used Extensively for Drugs; 4.3 Devices; 4.3.1 Use of Trials for Medical Devices; 4.3.2 Are Devices Different from Drugs?
• Sommario/riassunto: Learn rigorous statistical methods to ensure valid clinical trialsThis Second Edition of the critically hailed Clinical Trials builds on the text's reputation as a straightforward and authoritative presentation of statistical methods for clinical trials. Readers are introduced to the fundamentals of design for various types of clinical trials and then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of

Reds, whites, and blues : social movements, folk music, and race in the United States / / William G. Roy

• Record Nr.: UNINA9910972515203321
• Autore: Roy William G. <1946->
• Pubbl/distr/stampa: Princeton, : Princeton University Press, c2010
• ISBN: 9786612692185; 9781282692183; 1282692186; 9781400835164; 140083516X
• Edizione: [Course Book]
• Descrizione fisica: 1 online resource (311 p.)
• Collana: Princeton studies in cultural sociology
• Disciplina: 306.4/84240973
• Soggetti: Folk music - Political aspects - United States - History - 20th century; Social movements - United States - History - 20th century; Music and race - United States - History - 20th century
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: Front matter -- Contents -- Preface -- Chapter One. Social Movements, Music, and Race -- Chapter Two. Music and Boundaries: Race and Folk -- Chapter Three. The Original Folk Project -- Chapter Four. White and Black Reds: Building an Infrastructure -- Chapter Five. Movement Entrepreneurs and Activists -- Chapter Six. Organizing Music: The Fruits of Entrepreneurship -- Chapter Seven. The Highlander School -- Chapter Eight. Music at the Heart of the Quintessential Social Movement -- Chapter Nine. A Movement Splintered -- Chapter Ten. How Social Movements Do Culture -- Appendix. Coding of Songbooks and Song Anthologies -- Notes -- References -- Index -- Back matter
• Sommario/riassunto: Music, and folk music in particular, is often embraced as a form of political expression, a vehicle for bridging or reinforcing social boundaries, and a valuable tool for movements reconfiguring the social landscape. Reds, Whites, and Blues examines the political force of folk music, not through the meaning of its lyrics, but through the concrete social activities that make up movements. Drawing from rich archival ; material, William Roy shows that the People's Songs movement of the 1930's and 40's, and the Civil Rights Movement of the 1950's and 60's implemented folk music's social relationships--specifically between those who sang and those who listened--in different ways, achieving different outcomes. Roy explores how the People's Songsters envisioned uniting people in song, but made little headway beyond leftist activists. In contrast, the Civil Rights Movement successfully integrated music into collective action, and used music on the picket lines, at sit-ins, on freedom rides, and in jails. Roy considers how the movement's Freedom Songs never gained commercial success, yet contributed to the wider achievements of the Civil Rights struggle. Roy also traces the history of folk music, revealing the complex debates surrounding who or what qualified as "folk" and how the music's status as racially inclusive was not always a given. Examining folk music's galvanizing and unifying power, Reds, Whites, and Blues casts new light on the relationship between cultural forms and social activity.