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Clinical trials [[electronic resource] ] : a methodologic perspective / / Steven Piantadosi
Clinical trials [[electronic resource] ] : a methodologic perspective / / Steven Piantadosi
Autore Piantadosi Steven
Edizione [2nd ed.]
Pubbl/distr/stampa Hoboken, N.J., : Wiley-Interscience, c2005
Descrizione fisica 1 online resource (717 p.)
Disciplina 610/.72
615.50724
Collana Wiley series in probability and statistics
Soggetto topico Clinical trials - Statistical methods
Soggetto genere / forma Electronic books.
ISBN 1-280-27719-X
9786610277193
0-470-35561-1
0-471-74013-6
0-471-72781-4
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
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?
Record Nr. UNINA-9910147223003321
Piantadosi Steven  
Hoboken, N.J., : Wiley-Interscience, c2005
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Clinical trials [[electronic resource] ] : a methodologic perspective / / Steven Piantadosi
Clinical trials [[electronic resource] ] : a methodologic perspective / / Steven Piantadosi
Autore Piantadosi Steven
Edizione [2nd ed.]
Pubbl/distr/stampa Hoboken, N.J., : Wiley-Interscience, c2005
Descrizione fisica 1 online resource (717 p.)
Disciplina 610/.72
615.50724
Collana Wiley series in probability and statistics
Soggetto topico Clinical trials - Statistical methods
ISBN 1-280-27719-X
9786610277193
0-470-35561-1
0-471-74013-6
0-471-72781-4
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
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?
Record Nr. UNINA-9910830504303321
Piantadosi Steven  
Hoboken, N.J., : Wiley-Interscience, c2005
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Clinical trials : a methodologic perspective / / Steven Piantadosi
Clinical trials : a methodologic perspective / / Steven Piantadosi
Autore Piantadosi Steven
Edizione [2nd ed.]
Pubbl/distr/stampa Hoboken, N.J., : Wiley-Interscience, c2005
Descrizione fisica 1 online resource (717 p.)
Disciplina 610/.72
615.50724
Collana Wiley series in probability and statistics
Soggetto topico Clinical trials - Statistical methods
ISBN 1-280-27719-X
9786610277193
0-470-35561-1
0-471-74013-6
0-471-72781-4
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
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?
Record Nr. UNINA-9911019954403321
Piantadosi Steven  
Hoboken, N.J., : Wiley-Interscience, c2005
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui