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ClinicalTrials : Design, Conduct and Analysis.
First published in 1986, this landmark text is the definitive guide to clinical trials, written by one of the leading experts in the field. This fully-updated second edition continues to be the most authoritative reference text on randomized clinical trials. It contains a wealth of practical informa...
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Oxford University Press, USA,
2012.
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| Edición: | 2nd ed. |
| Colección: | Monographs in epidemiology and biostatistics.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Cover; Contents; PART 1. INTRODUCTION; Chapter 1 Introduction; 1.1 Clinical trial: Definition; 1.2 History of clinical trials; 1.3 Trials today; 1.4 Terminology: Conventions and definitions; 1.5 Focus; Chapter 2 The language of clinical trials; 2.1 Introduction; 2.2 On the language of relativity; 2.3 Random: The term; 2.4 The language of the epidemiologist vs the trialist; 2.5 Terminology: Recommendations and comments; Chapter 3 Types and classes of trials; 3.1 Introduction; 3.2 Treatment structure; 3.3 Sample size design; 3.4 Masking design; 3.5 Single-center and multicenter trials.
- 3.6 Purpose3.7 Treatment modality; 3.8 Big and simple trials; 3.9 Industry trials versus academic trials; Chapter 4 The state and nature of trials; 4.1 Introduction; 4.2 On assessing the state and nature of trials; 4.3 Published trials; 4.4 Gender-specific trials; 4.5 The Cochrane Library; 4.6 Registration of trials; 4.7 Registries of trials; 4.8 Other state measures; Chapter 5 The activities of clinical trials; 5.1 Stages of activities; 5.2 Division of responsibilities; 5.3 Impediments to performance of activities; 5.4 Aids to ensuring orderly transition of activities.
- Chapter 6 Coordinating and other resource centers in multicenter trials6.1 Introduction; 6.2 Coordinating centers; 6.3 Study chair and office of the study chair; 6.4 Central laboratories; 6.5 Reading centers; 6.6 Project offices; 6.7 Support centers; Chapter 7 Multi-study networks; 7.1 Introduction; 7.2 Examples of networks; 7.3 Advantages and disadvantages; 7.4 Modes of creation and funding; 7.5 Organizational structures; 7.6 Operating structures; Chapter 8 Ethical principles and imperatives in clinical trials; 8.1 Introduction; 8.2 Medical research codes.
- 8.3 Principles of medical ethics in research8.4 The state of clinical equipoise; 8.5 The ethics of choice of study treatments; 8.6 The monitoring imperative; 8.7 The ethics of disclosures for consents and of confl icts of interest; Chapter 9 Objectivity versus competency in clinical trials; 9.1 Introduction; 9.2 Objectivity constructs and rules; 9.3 Ethical limits of imposed objectivity constructs; PART 2. DESIGN PRINCIPLES AND PRACTICES; Chapter 10 Fundamentals of controlled clinical trials; 10.1 Introduction; 10.2 Choice of the test and control treatments.
- 10.3 Principles in the selection of the outcome measure10.4 Principles of establishing comparable treatment groups; 10.5 Principles of masking and bias control; Chapter 11 Bias; 11.1 Introduction; 11.2 Absolute versus relative truth and bias; 11.3 Selection and representation biases; 11.4 Treatment-related biases; 11.5 Indicators of bias; 11.6 Bias "fix," avoidance, and prevention strategies; Chapter 12 Bias control; 12.1 Introduction; 12.2 Randomization; 12.3 Concealment; 12.4 Masking philosophy of the trialist; 12.5 Specificity, training, and surveillance.