Bayesian Methods and Ethics in a Clinical Trial Design

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1996 | 322 Pages | ISBN: 0471846805 | PDF | 6 MB
How to conduct clinical trials in an ethical and scientifically responsible manner This book presents a methodology for clinical trials that produces improved health outcomes for patients while obtaining sound and unambiguous scientific data. It centers around a real-world test case--involving a treatment for hypertension after open heart surgery--and explains how to use Bayesian methods to accommodate both ethical and scientific imperatives. The book grew out of the direct involvement in the project by a diverse group of experts in medicine, statistics, philosophy, and the law. Not only do they contribute essays on the scientific, technological, legal, and ethical aspects of clinical trials, but they also critique and debate each other's opinions, creating an interesting, personalized text. Bayesian Methods and Ethics in a Clinical Trial Design * Answers commonly raised questions about Bayesian methods * Describes the advantages and disadvantages of this method compared with other methods * Applies current ethical theory to a particular class of design for clinical trials * Discusses issues of informed consent and how to serve a patient's best interest while still obtaining uncontaminated scientific data * Shows how to use Bayesian probabilistic methods to create computer models from elicited prior opinions of medical experts on the best treatment for a type of patient * Contains several chapters on the process, results, and computational aspects of the test case in question * Explores American law and the legal ramifications of using human subjects For statisticians and biostatisticians, and for anyone involved with medicine and public health, this book provides both a practical guide and a unique perspective on the connection between technological developments, human factors, and some of the larger ethical issues of our times.Content: Chapter 1 Introduction (pages 1-18): Joseph B. KadaneChapter 2 Ethically Optimizing Clinical Trials (pages 19-63): Kenneth F. SchaffnerChapter 3 Admissibility of Treatments (pages 65-113): Nell SedranskChapter 4 Statistical Issues in the Analysis of Data Gathered in the New Designs (pages 115-125): Joseph B. Kadane and Teddy SeidenfeldChapter 5 Introduction to the Verapamil/Nitroprusside Study (pages 127-130): Joseph B. KadaneChapter 6 The Mechanics of Conducting a Clinical Trial (pages 131-143): Eugenie S. Heitmiller and Thomas J. J. BlanckChapter 7 The Verapamil/Nitroprusside Study: Comments on "The Mechanics of Conducting a Clinical Trial" (pages 145-150): John L. CoulehanChapter 8 Computational Aspects of the Verapamil/Nitroprusside Study (pages 151-158): Lionel A. GalwayChapter 9 Being an Expert (pages 159-162): Thomas J. J. Blanck, Thomas J. Conahan, Robert G. Merin, Richard L. Prager and James J. RichterChapter 10 Issues of Statistical Design (pages 163-170): Nell SedranskChapter 11 Operational History and Procedural Feasibility (pages 171-175): Joseph B. KadaneChapter 12 Verapamil versus Nitroprusside: Results of the Clinical Trial I (pages 177-210): Joseph B. Kadane and Nell SedranskChapter 13 Verapamil versus Nitroprusside: Results of the Clinical Trial II (pages 211-219): Eugenie S. Heitmiller, Joseph B. Kadane, Nell Sedransk and Thomas J. J. BlanckChapter 14 The Law of Clinical Testing with Human Subjects: Legal Implications of the New and Existing Methodologies (pages 221-249): David KairysChapter 15 Commentary I on "The Law of Clinical Testing with Human Subjects" (pages 251-255): Dale Moore and A. John PoppChapter 16 Commentary II on "The Law of Clinical Testing with Human Subjects" (pages 257-261): Katheryn D. KatzChapter 17 Author's Response to Commentaries I and II (pages 263-266): David KairysChapter 18 Whether to Participate in a Clinical Trial: The Patient's View (pages 267-305): Lawrence J. Emrich and Nell SedranskChapter 19 Epilogue (pages 307-310): Joseph B. Kadane


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