Guide to clinical trials:
Saved in:
| Main Author: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York
Raven Press
1991
|
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Item Description: | Literaturverz. S. 1079 - 1103 |
| Physical Description: | XXV, 1156 S. Ill., graph. Darst. |
| ISBN: | 0881677671 |
Staff View
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Record in the Search Index
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| adam_text | GUIDE TO CLINICAL TRIALS BERT SPILKER, PH.D., M.D. DIRECTOR, PROJECT
COORDINATION, BURROUGHS WELLCOME CO. RESEARCH TRIANGLE PARK, NORTH
CAROLINA ADJUNCT PROFESSOR OF PHARMACOLOGY AND ADJUNCT PROFESSOR OF
MEDICINE UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE CLINICAL
PROFESSOR OF PHARMACY UNIVERSITY OF NORTH CAROLINA SCHOOL OF PHARMACY
CHAPEL HILL, NORTH CAROLINA RAVEN PRESS JF NEW YORK CONTENTS FOREWORD
XIII PREFACE XV ACKNOWLEDGMENTS XVIII TERMINOLOGY XX ABOUT THE AUTHOR
XXV 1 INTRODUCTION: AN OVERVIEW OF APPROACHES USED IN THIS BOOK 1 PART
I: DEVELOPING CLINICAL TRIAL DESIGNS 2 ESTABLISHING THE OVERALL APPROACH
TO A CLINICAL TRIAL 7 3 ESTABLISHING CLINICAL TRIAL OBJECTIVES 10 4
CHOOSING AND VALIDATING THE CLINICAL TRIAL S BLIND 15 5 BIAS AND
CONFOUNDING FACTORS 21 6 CLASSIFICATION AND DESCRIPTION OF PHASES I, II,
AND III CLINICAL TRIAL DESIGNS 27 7 CLASSIFICATION AND DESCRIPTION OF
PHASE IV POSTMARKETING STUDY DESIGNS 44 8 CONTROLS USED IN CLINICAL
TRIALS 59 9 SAMPLE SIZE AND NUMBER OF PARTS OF A CLINICAL TRIAL 65 10
RANDOMIZATION PROCEDURES 69 11 SCREENING, BASELINE, TREATMENT, AND
POSTTREATMENT PERIODS 74 12 PATIENT POPULATIONS, CLINICAL TRIAL
ENVIRONMENT, AND THE PLACEBO EFFECT 78 13 PATIENT RECRUITMENT 85 14
DOSING SCHEDULE 93 15 METHODS OF ASSESSING AND IMPROVING PATIENT
COMPLIANCE IN CLINICAL TRIALS 102 16 PHARMACOKINETIC PRINCIPLES 115 17
DATA REVIEW COMMITTEES 124 18 DOSAGE FORMS AND FORMULATIONS 129 19
ROUTES OF ADMINISTRATION 137 VII CONTENTS PART II: DEVELOPING AND
WRITING CLINICAL PROTOCOLS FORMULATING AN APPROACH TO DEVELOPING A
PROTOCOL 145 ESTABLISHING CRITERIA FOR PATIENT INCLUSION 147
IDENTIFYING, CHOOSING, AND EVALUATING EFFICACY PARAMETERS 159
IDENTIFYING AND CHOOSING SAFETY PARAMETERS 169 DEVELOPING TIME AND
EVENTS SCHEDULES 184 PREPARING, PACKAGING, AND DISPENSING OF CLINICAL
TRIAL MEDICATIONS 188 COLLECTING ADVERSE EVENT AND ADVERSE REACTION DATA
IN CLINICAL TRIALS 196 INFORMED CONSENT AND ETHICS
COMMITTEE/INSTITUTIONAL REVIEW BOARD PROCESSES 202 REMOTE DATA ENTRY 219
PREPARING THE INTRODUCTION 224 STANDARDIZING INFORMATION ACROSS
PROTOCOLS 225 PATIENT REFUSERS, NONQUALIFIES, DROPOUTS, DROPINS, AND
DISCONTINUERS .. 235 REGULATORY, PATENT, AND LEGAL CONSIDERATIONS 242
ETHICAL CONSIDERATIONS AND ISSUES 245 COMPLETING AND REVIEWING THE
INITIAL DRAFT 258 IMPROVING THE QUALITY OF A PROTOCOL 260 PREPARING DATA
COLLECTION FORMS 262 INSTRUCTIONS FOR PATIENTS, INVESTIGATORS, AND STUDY
PERSONNEL 272 PART III: PLANNING SPECIAL TYPES OF CLINICAL TRIALS
SINGLE-PATIENT CLINICAL TRIALS 277 MULTICENTER TRIALS 283 NATIONAL
VERSUS MULTINATIONAL CLINICAL TRIALS 287 41 CONTINUATION AND
COMPASSIONATE PLEA TRIALS 295 42 PHARMACOECONOMIC TRIALS 302 43
VALIDATION OF CLINICAL TESTS AND MEASURES 313 44 SURGICAL TRIALS 320 45
CLINICAL TRIALS TO EVALUATE MEDICAL DEVICES 329 46 EVALUATING ORPHAN
MEDICINES FOR TREATMENT OF RARE DISEASES 334 47 CLINICAL TRIALS IN
ELDERLY PATIENTS 342 48 PHARMACOKINETIC TRIALS 347 49 COMPARING
DIFFERENT DOSAGE FORMS OR TREATMENT MODALITIES 359 50 COMBINATION
MEDICINE TRIALS 361 51 MARKETING-ORIENTED CLINICAL STUDIES 367 52
QUALITY OF LIFE TRIALS 370 CONIENIS PART IV: PLANNING AND CONDUCTING A
SINGLE CLINICAL TRIAL 53 INTRODUCTION 381 54 TRAINING PROFESSIONALS AND
THEIR STAFF IN CLINICAL TRIAL METHODS 382 55 INTERACTIONS OF ACADEMIC
INVESTIGATORS WITH PHARMACEUTICAL COMPANIES 390 56 ROLES OF PRIVATE
PRACTICE PHYSICIANS IN CLINICAL TRIALS 395 57 PATIENTS PERSPECTIVES
ABOUT CLINICAL TRIALS 398 58 ROLES OF MEDICAL CONTRACT ORGANIZATIONS 403
59 CHOOSING CLINICAL INVESTIGATORS 410 60 CONDUCTING A PRETRIAL
ROUNDTABLE MEETING 418 61 CLINICAL TRIAL INITIATION AND CONDUCT 423 62
MONITORING A CLINICAL TRIAL 430 63 AUDITING A CLINICAL TRIAL 449 64
MISCONDUCT OR DECEPTION DURING A CLINICAL TRIAL 458 65 CLINICAL TRIAL
TERMINATION OR EXTENSION 464 PART V: A NONMATHEMATICAL APPROACH TO
STATISTICS AND DATA PROCESSING 66 DEVELOPING AN OVERALL APPROACH TO DATA
PROCESSING AND STATISTICAL ANALYSIS 473 67 SYSTEMS FOR CLASSIFYING
DISEASES AND ADVERSE REACTIONS 479 68 DATA PROCESSING 482 69 INTERIM
ANALYSES 490 70 STATISTICAL ISSUES 497 PART VI: FUNDAMENTAL PRINCIPLES,
CONSIDERATIONS, AND TECHNIQUES IN THE INTERPRETATION OF CLINICAL DATA 71
SUMMARY OF PRINCIPLES AND PROCEDURES TO FOLLOW 505 72 DEVELOPMENT AND
USE OF CLINICAL JUDGMENT 519 73 CONCEPT OF CAUSE AND EFFECT 528 74
CLINICAL SIGNIFICANCE VERSUS STATISTICAL SIGNIFICANCE OF ABNORMAL DATA
.... 536 75 SIMPSON S PARADOX: A CASE AGAINST COMMON SENSE 543 76 THE
ART OF DEVELOPING AND TESTING HYPOTHESES 545 77 SPECIFIC TECHNIQUES AND
ISSUES IN INTERPRETING CLINICAL DATA 548 78 RELEVANCE OF CLINICAL TRIALS
FOR MEDICAL PRACTICE 553 PART VII: INTERPRETATION OF SAFETY AND EFFICACY
DATA 79 PATIENT DEMOGRAPHICS AND ACCOUNTABILITY 561 80 INTERPRETATION OF
ADVERSE REACTIONS 565 81 INTERPRETATION OF LABORATORY AND OTHER SAFETY
DATA 588 82 GENERAL APPROACHES TO INTERPRETING EFFICACY DATA 600 83
SPECIFIC FACTORS TO CONSIDER IN INTERPRETING EFFICACY AND SAFETY DATA
.... 612 CONTENTS PART VIII: INTERPRETATION OF DATA FROM SPECIAL TRIALS,
MODALITIES, AND POPULATIONS 84 INTERPRETATION OF PHARMACOKINETIC DATA
639 85 INTERPRETATION OF DATA FROM SURGICAL TRIALS 648 86 SPECIAL
MODALITIES: BIOFEEDBACK, RADIATION THERAPY, HYPERTHERMIA, HYPNOSIS,
ELECTROCONVULSIVE THERAPY, APHERESIS, AND HYPERBARIC OXYGEN 653 87
SPECIAL PATIENT POPULATIONS 658 PART IX: ISSUES AND PROBLEMS OF CLINICAL
DATA INTERPRETATION 88 EXTRAPOLATION OF SAFETY (I.E., TOXICOLOGICAL)
DATA FROM ANIMALS TO HUMANS 675 89 EXTRAPOLATION OF EFFICACY (I.E.,
PHARMACOLOGICAL) DATA FROM ANIMALS TO HUMANS 684 90 EXTRAPOLATION OF
DATA FROM CLINICAL TRIALS 694 91 DATA THAT ARE DIFFICULT TO INTERPRET
703 92 RECONCILING DIFFERENT INTERPRETATIONS FROM DIFFERENT TRIALS 709
93 INTERPRETING PLACEBO DATA 713 94 INTERPRETING DATA FROM ACTIVE
MEDICINE CONTROL GROUPS 720 95 INTERACTIONS AMONG MEDICINES 723 96
FALSE-POSITIVE AND FALSE-NEGATIVE RESULTS 726 97 INTERPRETING QUALITY OF
LIFE DATA 729 98 RESPONDERS AND NONRESPONDERS 733 99 BENEFIT-TO-RISK
ASSESSMENTS AND COMPARISONS 738 100 COORDINATION AND INTEGRATION OF
STATISTICAL ANALYSES WITH CLINICAL INTERPRETATIONS 747 101
MISINTERPRETATION OF DATA 750 PART X: PUBLISHING CLINICAL DATA AND
EVALUATING PUBLISHED LITERATURE 102 PREPARING ARTICLES FOR PUBLICATION
759 103 SYSTEMS TO EVALUATE PUBLISHED DATA 772 104 META-ANALYSIS 793 105
MISPRESENTATION OF CLINICAL DATA 801 106 METHODS FOR AUTHORS AND
JOURNALS TO IMPROVE THE QUALITY OF CLINICAL PUBLICATIONS 807 107
PROSPECTIVE REGISTRATION OF CLINICAL TRIALS 816 108 ARCHIVING CLINICAL
TRIAL DATA 820 109 MODELS OF CLINICAL RESEARCH 823 CONTENTS / PART XI:
PLANNING AND CONDUCTING MULTIPLE CLINICAL TRIALS 110 GOLDEN RULES OF
CLINICAL DEVELOPMENT OF PHARMACEUTICALS 831 111 CHOOSING A PROJECT OR
MEDICINE FOR EVALUATION 837 112 MISSIONS, OBJECTIVES, GOALS, STRATEGIES,
AND TACTICS 849 1 13 ESTABLISHING PROJECT STRATEGIES AND GOALS 856 114
ELEMENTS OF A CLINICAL STRATEGY 864 1 15 DESIGNING A CLINICAL
DEVELOPMENT PLAN 870 1 16 COMBINING EFFICACY DATA FROM MULTIPLE TRIALS
889 117 COMBINING SAFETY DATA FROM MULTIPLE TRIALS 896 118 SPECIFIC
THERAPEUTIC AND DISEASE AREAS: METHODOLOGICAL CONSIDERATIONS 904 119
SAFETY DATA REQUIRED FOR A NEW MEDICINE AT THE TIME OF INITIAL MARKETING
908 120 STANDARDS OF POSTMARKETING SURVEILLANCE: PAST, PRESENT, AND
FUTURE 916 121 DEVELOPING MEDICINES WORLDWIDE 926 PART XII: MANAGEMENT
OF MULTIPLE CLINICAL TRIALS 122 MANAGEMENT STYLES, STAFF, AND SYSTEMS
953 123 PRIORITIZATION OF ACTIVITIES AND ALLOCATION OF BOTH RESOURCES
AND SUPPLIES 961 124 COORDINATION AND MANAGEMENT OF MULTIPLE PROJECTS
967 125 USE OF MEETINGS AND DOCUMENTS TO ASSIST IN PLANNING AND MANAGING
CLINICAL TRIALS 986 126 INTERACTIONS OF REGULATORY DEPARTMENTS,
REGULATORY AUTHORITIES, AND MEDICAL DEPARTMENTS 1006 127 REGULATORY
ISSUES FROM A SPONSOR S PERSPECTIVE 1028 128 REGULATORY ISSUES FROM A
NATIONAL REGULATORY AUTHORITY S PERSPECTIVE .. 1036 129 INTERACTIONS OF
MARKETING WITH RESEARCH AND DEVELOPMENT DEPARTMENTS 1041 130 COSTS OF
CLINICAL TRIALS, PROJECTS, AND PHARMACEUTICAL DEVELOPMENT 1050 131
TERMINATING A PROJECT 1063 132 DISSEMINATION OF CLINICAL TRIAL RESULTS
TO MEDICAL PRACTICE 1066 133 FUTURE DIRECTIONS AND GOALS FOR CLINICAL
TRIALS 1072 REFERENCES 1079 SUBJECT INDEX 1 ]05 AUTHOR INDEX 1149
|
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| indexdate | 2024-07-09T16:16:25Z |
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| isbn | 0881677671 |
| language | English |
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| physical | XXV, 1156 S. Ill., graph. Darst. |
| publishDate | 1991 |
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| publishDateSort | 1991 |
| publisher | Raven Press |
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| spelling | Spilker, Bert Verfasser (DE-588)17151419X aut Guide to clinical trials Bert Spilker New York Raven Press 1991 XXV, 1156 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Literaturverz. S. 1079 - 1103 Klinische farmacologie gtt Laboratoriumonderzoek gtt Médicaments - Essais cliniques Études cliniques Clinical Trials as Topic Clinical trials Drug Evaluation Drugs Testing Research Design Versuchsplanung (DE-588)4078859-3 gnd rswk-swf Medizin (DE-588)4038243-6 gnd rswk-swf Versuchsplanung (DE-588)4078859-3 s Medizin (DE-588)4038243-6 s DE-604 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=002891697&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Spilker, Bert Guide to clinical trials Klinische farmacologie gtt Laboratoriumonderzoek gtt Médicaments - Essais cliniques Études cliniques Clinical Trials as Topic Clinical trials Drug Evaluation Drugs Testing Research Design Versuchsplanung (DE-588)4078859-3 gnd Medizin (DE-588)4038243-6 gnd |
| subject_GND | (DE-588)4078859-3 (DE-588)4038243-6 |
| title | Guide to clinical trials |
| title_auth | Guide to clinical trials |
| title_exact_search | Guide to clinical trials |
| title_full | Guide to clinical trials Bert Spilker |
| title_fullStr | Guide to clinical trials Bert Spilker |
| title_full_unstemmed | Guide to clinical trials Bert Spilker |
| title_short | Guide to clinical trials |
| title_sort | guide to clinical trials |
| topic | Klinische farmacologie gtt Laboratoriumonderzoek gtt Médicaments - Essais cliniques Études cliniques Clinical Trials as Topic Clinical trials Drug Evaluation Drugs Testing Research Design Versuchsplanung (DE-588)4078859-3 gnd Medizin (DE-588)4038243-6 gnd |
| topic_facet | Klinische farmacologie Laboratoriumonderzoek Médicaments - Essais cliniques Études cliniques Clinical Trials as Topic Clinical trials Drug Evaluation Drugs Testing Research Design Versuchsplanung Medizin |
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