UID:
almahu_9949697624602882
Format:
1 online resource (560 p.)
ISBN:
1-281-76238-5
,
9786611762384
,
0-08-055793-7
Content:
Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, this book covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results.*Jargon-free writing style enables those with less experience to run their own clinical
Note:
Includes index.
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Front Cover; Principles and Practice of Clinical Trial Medicine; Copyright Page; Contents; About the Authors; Introduction; Section I: Overview; Chapter 1: Overview of Clinical Research Medicine; 1.1 CLINICAL RESEARCH MEDICINE; 1.2 RATIONALE FOR CLINICAL TRIALS; 1.3 LIMITATIONS OF CLINICAL TRIALS; 1.4 CHARACTERISTICS AND PERFORMANCE CRITERIA OF CTM; 1.5 TYPES OF CLINICAL STUDIES; 1.6 PERFORMANCE CRITERIA FOR WELL-DESIGNED CLINICAL TRIALS; 1.7 CRITICAL PARAMETERS IN CLINICAL TRIAL DESIGN; Chapter 2: Ethical, Legal, and Regulatory Issues; 2.1 RULES AND REGULATIONS; 2.2 ETHICAL PRINCIPLES
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2.3 PROTECTING PATIENTS RIGHTS AND WELFARE2.4 CLINICAL RESEARCH AND MANUFACTURING STANDARDS; 2.5 US PHARMACEUTICAL APPROVAL PROCESS; 2.6 US MEDICAL DEVICE APPROVAL PROCESS; 2.7 POST-APPROVAL; Section II: The General Structure of Clinical Trials and Programs; Chapter 3: Introduction to Clinical Trial Statistics; 3.1 INTRODUCTION; 3.2 STATISTICS AND PARAMETERS; 3.3 NORMAL DISTRIBUTION; 3.4 SAMPLING DISTRIBUTIONS; 3.5 CORRELATION; 3.6 HYPOTHESIS TESTING; 3.7 POWER; 3.8 SAMPLE SIZE; Chapter 4: Measures and Variables; 4.1 INTRODUCTION TO MEASURES; 4.2 THE IMPORTANCE OF MEASURES
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4.3 CHOOSING THE RIGHT MEASURES4.4 ACCURACY AND PRECISION; 4.5 MEASUREMENT ERRORS; 4.6 STRATEGIES TO MAXIMIZE ACCURACY AND PRECISION; 4.7 VALIDITY; Chapter 5: Study Groups; 5.1 RATIONALE FOR CONTROL GROUPS; 5.2 PLACEBOS, SHAM DEVICES, AND SHAM PROCEDURES; 5.3 CHOOSING CONTROLS; 5.4 STUDY GROUP ALLOCATIONS; 5.5 BLINDING (MASKING); 5.6 BREAKING THE BLIND; Chapter 6: Periods, Sequences, and Trial Design; 6.1 BACKGROUND; 6.2 PARALLEL DESIGNS; 6.3 WITHIN-PATIENT DESIGNS; 6.4 FACTORIAL DESIGNS; 6.5 NESTED DESIGNS; 6.6 SEQUENTIAL DESIGNS; 6.7 PERIODS PRECEDING THE STUDY PERIODS
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6.8 TREATMENT AND FOLLOW-UP6.9 ADDITIONAL MULTI-PERIOD DESIGNS; 6.10 DESIGNS TO MINIMIZE EXPOSURE TO INEFFECTIVE TREATMENTS; Section III: Key Components of Clinical Trials and Programs; Chapter 7: Endpoints; 7.1 CHOOSING THE RIGHT ENDPOINTS; 7.2 CLINICAL RELEVANCE; 7.3 RESPONSIVENESS AND ANALYSIS; 7.4 PRIMARY AND SECONDARY ENDPOINTS; 7.5 COMPOSITE ENDPOINTS; 7.6 SAFETY ENDPOINTS; 7.7 SURROGATE ENDPOINTS; 7.8 DIFFERENT TYPES OF ENDPOINTS; Chapter 8: Economics and Patient Reported Outcomes; 8.1 HEALTH ECONOMICS AND PHARMACOECONOMICS; 8.2 TIME; 8.3 VALUATION; 8.4 TYPES OF ECONOMIC ANALYSES
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8.5 PATIENT REPORTED OUTCOMES (PRO)8.6 INSTRUMENTS; 8.7 QUESTIONNAIRE AND INTERVIEW QUESTIONS; 8.8 RESPONSE OPTIONS; 8.9 RESPONSE RATE; Chapter 9: Patient Selection and Sampling; 9.1 DEFINING THE STUDY POPULATION; 9.2 SELECTION (INCLUSION AND EXCLUSION) CRITERIA; 9.3 SAMPLING; Chapter 10: Dosing and Intervention; 10.1 BACKGROUND; 10.2 OVERVIEW OF DOSE SELECTION; 10.3 PHARMACOKINETICS; 10.4 DOSE-RESPONSE; 10.5 COMPONENTS OF DOSING; 10.6 PHASE I DOSE STUDIES; 10.7 RESPONSE PARAMETERS; 10.8 POPULATION PHARMACOKINETICS AND PHARMACODYNAMICS; 10.9 DOSE-RESPONSE STUDY DESIGN
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10.10 SPECIAL POPULATIONS
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English
Additional Edition:
ISBN 0-12-373695-1
Language:
English
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