LEADER 01193nam0-2200337 --450 001 9910633793103321 005 20230105144103.0 010 $a083770037X 100 $a20230105h1972----kmuy0itay5050 ba 101 0 $aeng 102 $aUS 105 $a 001yy 200 1 $a<>Penal code of Sweden$eas amended January 1st, 1972$aoriginally translated by Thorsten Sellin$aamendments translated by Jerome L. Getz$aintroductio by Lennart Geijer 210 $aLittleton, Colorado$cFred B. Rothmann & Co.$aLondon$cSweet & Maxwell$d1972 215 $aX, 114 p.$d21 cm 225 1 $a<>American series of foreign penal codes$v17 676 $a345$v23$zita 702 1$aSellin,$bThorsten 702 1$aGeijer,$bLennart 702 1$aGetz,$bJerome L. 710 02$aSvezia$4070$0352948 801 0$aIT$bUNINA$gREICAT$2UNIMARC 901 $aBK 912 $a9910633793103321 952 $aXII Z 211 (17)$b95166$fFGBC 959 $aFGBC 996 $aAmendments translated by Jerome L. Getz$92996643 996 $aIntroductio by Lennart Geijer$92996644 996 $aPenal code of Sweden$92996641 996 $aOriginally translated by Thorsten Sellin$92996642 997 $aUNINA LEADER 05301nam 22006494a 450 001 9911019954403321 005 20250901160824.0 010 $a1-280-27719-X 010 $a9786610277193 010 $a0-470-35561-1 010 $a0-471-74013-6 010 $a0-471-72781-4 035 $a(CKB)1000000000297443 035 $a(EBL)232612 035 $a(OCoLC)475938695 035 $a(SSID)ssj0000123720 035 $a(PQKBManifestationID)11132685 035 $a(PQKBTitleCode)TC0000123720 035 $a(PQKBWorkID)10008649 035 $a(PQKB)11122381 035 $a(MiAaPQ)EBC232612 035 $a(MiAaPQ)EBC4037039 035 $a(EXLCZ)991000000000297443 100 $a20050214d2005 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aClinical trials $ea methodologic perspective /$fSteven Piantadosi 205 $a2nd ed. 210 $aHoboken, N.J. $cWiley-Interscience$dc2005 215 $a1 online resource (717 p.) 225 1 $aWiley series in probability and statistics 300 $aDescription based upon print version of record. 311 08$a0-471-74012-8 320 $aIncludes bibliographical references (p. 613-658 ) and indexes. 327 $aCLINICAL 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 327 $a2.2.1 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 327 $a2.4 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 327 $a3.3.2 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 327 $a3.5.1 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 327 $a4.3.2 Are Devices Different from Drugs? 330 $aLearn 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. 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