Randomized Clinical Trials: Design, Practice and Reporting
Using examples and case studies from industry, academia and research literature, Randomized Clinical Trials provides a detailed overview of the key issues involved in designing, conducting, analysing and reporting randomized clinical trials. It examines the methodology for conducting Phase III clinical trials, developing the protocols, the practice for capturing, measuring, and analysing the resulting clinical data and their subsequent reporting. Randomized clinical trials are the principal me…
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- Full title :Randomized Clinical Trials : Design, Practice and Reporting.
Summary
Using examples and case studies from industry, academia and research literature, Randomized Clinical Trials provides a detailed overview of the key issues involved in designing, conducting, analysing and reporting randomized clinical trials. It examines the methodology for conducting Phase III clinical trials, developing the protocols, the practice for capturing, measuring, and analysing the resulting clinical data and their subsequent reporting. Randomized clinical trials are the principal method for determining the relative efficacy and safety of alternative treatments, interventions or medical devices. They are conducted by groups comprising one or more of pharmaceutical and allied health-care organisations, academic institutions, and charity supported research groups. In many cases such trials provide the key evidence necessary for the regulatory approval of a new product for future patient use. Randomized Clinical Trials provides comprehensive coverage of such trials, ranging from elementary to advanced level. Written by authors with considerable experience of clinical trials, Randomized Clinical Trials is an authoritative guide for clinicians, nurses, data managers and medical statisticians involved in clinical trials research and for health care professionals directly involved in patient care in a clinical trial context.
Read More ↓Edition Statements
- Publication Date:2010.
Publication Statements
- Publisher(s):John Wiley & Sons
- Language:eng
- Publication Date:2010.
The Physical Object
- Description:1 online resource (376)
Edition Identifiers
- ISBN:9780471498124, 0471498122, 9780470319222, 0470319224, 1282689614, 9781282689619, 9786612689611, 6612689617, 0470686235, 9780470686232, 0471497797, 9780471497790
- oclc:ocn733730694
- LC Classification:R853.C55
- Dewey Decimal:615.19
Table of Contents
Cover -- Title Page -- Copyright Page -- Table of Contents -- Preface -- 1 Introduction -- 1.1 Introduction -- 1.2 Some completed trials -- 1.3 Choice of design -- 1.4 Practical constraints -- 1.5 Influencing clinical practice -- 1.6 History -- 1.7 How trials arise -- 1.8 Ethical considerations -- 1.9 Regulatory requirements -- 1.10 Focus -- 1.11 Further reading -- 2 Design Features -- 2.1 Introduction -- 2.2 The research question -- 2.3 Patient selection -- 2.4 The consent process -- 2.5 Choice of interventions -- 2.6 Choice of design -- 2.7 Assigning the interventions -- 2.8 Making the assessments -- 2.9 Analysis and reporting -- 2.10 Technical details -- 2.11 Guidelines -- 2.12 Further reading -- 3 The Trial Protocol -- 3.1 Introduction -- 3.2 Protocol 8230; abstract -- 3.3 Protocol 8230; background -- 3.4 Protocol 8230; research objectives -- 3.5 Protocol 8230; design -- 3.6 Protocol 8230; intervention details -- 3.7 Protocol 8230; eligibility -- 3.8 Protocol 8230; randomization -- 3.9 Protocol 8230; assessment and data collection -- 3.10 Protocol 8230; statistical considerations -- 3.11 Protocol 8230; ethical issues -- 3.12 Protocol 8230; organizational structure -- 3.13 Prot…
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