Principles and practice of clinical trial medicine /

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 considerabl...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Chin, Richard Y. (Richard Yoonsik)
Otros Autores: Lee, Bruce Y.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Amsterdam ; Boston : Elsevier/Academic Press, �2008.
Temas:
Clinical trials.
Medical protocols.
Clinical Protocols
Clinical Trials as Topic > methods
Research Design
�Etudes cliniques.
Protocoles m�edicaux.
HEALTH & FITNESS > Alternative Therapies.
MEDICAL > Healing.
HEALTH & FITNESS > Healing.
BODY, MIND & SPIRIT > Healing > General.
Medical protocols
Clinical trials
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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
  • 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
  • 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
  • 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
  • 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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