A Concise Guide to Clinical Trials

Allan Hackshaw 지음

Wiley-Blackwell 2024년 05월 07일 출간

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Design and execute life-saving trials with this accessible resource Clinical trials have revolutionized the treatment of disease and the development of life-saving pharmaceuticals. They contribute decisively to diagnosis, the avoidance of early death, medical intervention and are central to the modern work of pharmaceutical producers. The design and execution of clinical trials is one of the fastest-growing and most important areas of medical and pharmaceutical research. A Concise Guide to Clinical Trials provides an accessible and comprehensive survey of clinical trials, their design, and their applications. Beginning with a taxonomy of trial types, the book overviews stages of analysis, ethical and legal requirements, and more. Now fully updated to reflect the latest research and clinical practice, it continues to be an indispensable resource for researchers and clinicians. Readers of the second edition of A Concise Guide to Clinical Trials will also find: New material on pharmaceutical trials, adaptive designs, and the use of “big data” The easy-to-use organization facilitates both first-time learning and reference Detailed treatment of concepts such as health technology assessments (HTA), patient and public involvement and engagement (PPIE), and more A Concise Guide to Clinical Trials is ideal for clinicians and healthcare professionals looking for a working knowledge of clinical trials, as well as for pharmaceutical workers and regulators looking to understand this vital aspect of the industry.

목차

Preface ix Foreword xi 1 Fundamental concepts 1 1.1 What is a clinical trial? 1 1.2 Early trials 2 1.3 Why clinical trials are needed 3 1.4 Alternatives to clinical trials 3 1.5 Types of clinical trials 5 1.6 Key design features 7 1.7 Summary points 13 2 Types of outcome measures and understanding them 15 2.1 Clinical trial outcome measures (endpoints) 15 2.2 ‘True’ versus surrogate outcome measures 16 2.3 Types of outcomes 18 2.4 Counting people 18 2.5 Taking measurements on people 19 2.6 Time-to-event measures 21 2.7 Patient-reported outcome measures (PROMs) 25 2.8 Summary points 27 3 Phase I trials 29 3.1 Trial objectives 29 3.2 Types of participants 30 3.3 Outcome measures 30 3.4 Designs 32 3.5 Conducting the trial 37 3.6 Statistical analysis and reporting the trial results 37 3.7 Summary points 39 4 Phase II trials 41 4.1 Trial objectives 41 4.2 Designs 41 4.3 Outcome measures 48 4.4 Estimating study size 48 4.5 Stopping early for toxicity 50 4.6 Statistical analyses 51 4.7 Interpreting phase II studies 55 4.8 Summary points 56 5 Phase III trials: design 59 5.1 Trial objectives 59 5.2 Designs 59 5.3 Inclusion and exclusion criteria 62 5.4 Experimental/investigational treatment group 64 5.5 Control (comparator) group 64 5.6 Randomisation and allocating participants 65 5.7 Blinding (placebo) 66 5.8 Outcome measures 66 5.9 Participant follow-up 68 5.10 Estimating study size 69 5.11 Non-inferiority and equivalence 72 5.12 Multiplicity: multiple treatment arms or multiple outcome measures 74 5.13 Participants who switch trial interventions (crossover) 75 5.14 Summary points 76 <

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저자(글) Allan Hackshaw