The assessment of patient reported outcomes and health-related quality of life continue to be rapidly evolving areas of research and this new edition reflects the development within the field from an emerging subject to one that is an essential part of the assessment of clinical trials and other clinical studies.The analysis and interpretation of quality-of-life assessments relies on a variety of psychometric and statistical methods which are explained in this book in a non-technical way. The result is a practical guide that covers a wide range of methods and emphasizes the use of simple techniques that are illustrated with numerous examples, with extensive chapters covering qualitative and quantitative methods and the impact of guidelines. The material in this new third edition reflects current teaching methods and content widened to address continuing developments in item response theory, computer adaptive testing, analyses with missing data, analysis of ordinal data, systematic reviews and meta-analysis.This book is aimed at everyone involved in quality-of-life research and is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and clinical practice.

The assessment of patient reported outcomes and health-related quality of life continue to be rapidly evolving areas of research and this new edition reflects the development within the field from an emerging subject to one that is an essential part of the assessment of clinical trials and other clinical studies.The analysis and interpretation of quality-of-life assessments relies on a variety of psychometric and statistical methods which are explained in this book in a non-technical way. The result is a practical guide that covers a wide range of methods and emphasizes the use of simple techniques that are illustrated with numerous examples, with extensive chapters covering qualitative and quantitative methods and the impact of guidelines. The material in this new third edition reflects current teaching methods and content widened to address continuing developments in item response theory, computer adaptive testing, analyses with missing data, analysis of ordinal data, systematic reviews and meta-analysis.This book is aimed at everyone involved in quality-of-life research and is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and clinical practice.

Randomised Clinical Trials: Design, Practice and Reporting provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation, analysis and reporting. Assuming no prior background, this user-friendly resource describes the statistical, regulatory, and practical components required for conducting randomised clinical trials. Numerous examples and case studies from industry, academia, and the research literature help readers understand each stage of the clinical trial process.

This second edition contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials. Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies. Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes. Written by an author team with extensive experience in conducting clinical trials, this book:

Randomised Clinical Trials is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting.

Randomised Clinical Trials: Design, Practice and Reporting provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation, analysis and reporting. Assuming no prior background, this user-friendly resource describes the statistical, regulatory, and practical components required for conducting randomised clinical trials. Numerous examples and case studies from industry, academia, and the research literature help readers understand each stage of the clinical trial process.

This second edition contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials. Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies. Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes. Written by an author team with extensive experience in conducting clinical trials, this book:

Randomised Clinical Trials is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting.

The assessment of patient reported outcomes and health-related quality of life continue to be rapidly evolving areas of research and this new edition reflects the development within the field from an emerging subject to one that is an essential part of the assessment of clinical trials and other clinical studies.The analysis and interpretation of quality-of-life assessments relies on a variety of psychometric and statistical methods which are explained in this book in a non-technical way. The result is a practical guide that covers a wide range of methods and emphasizes the use of simple techniques that are illustrated with numerous examples, with extensive chapters covering qualitative and quantitative methods and the impact of guidelines. The material in this new third edition reflects current teaching methods and content widened to address continuing developments in item response theory, computer adaptive testing, analyses with missing data, analysis of ordinal data, systematic reviews and meta-analysis.This book is aimed at everyone involved in quality-of-life research and is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and clinical practice.

The assessment of patient reported outcomes and health-related quality of life continue to be rapidly evolving areas of research and this new edition reflects the development within the field from an emerging subject to one that is an essential part of the assessment of clinical trials and other clinical studies.The analysis and interpretation of quality-of-life assessments relies on a variety of psychometric and statistical methods which are explained in this book in a non-technical way. The result is a practical guide that covers a wide range of methods and emphasizes the use of simple techniques that are illustrated with numerous examples, with extensive chapters covering qualitative and quantitative methods and the impact of guidelines. The material in this new third edition reflects current teaching methods and content widened to address continuing developments in item response theory, computer adaptive testing, analyses with missing data, analysis of ordinal data, systematic reviews and meta-analysis.This book is aimed at everyone involved in quality-of-life research and is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and clinical practice.

Randomised Clinical Trials: Design, Practice and Reporting provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation, analysis and reporting. Assuming no prior background, this user-friendly resource describes the statistical, regulatory, and practical components required for conducting randomised clinical trials. Numerous examples and case studies from industry, academia, and the research literature help readers understand each stage of the clinical trial process.

This second edition contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials. Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies. Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes. Written by an author team with extensive experience in conducting clinical trials, this book:

Randomised Clinical Trials is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting.

Randomised Clinical Trials: Design, Practice and Reporting provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation, analysis and reporting. Assuming no prior background, this user-friendly resource describes the statistical, regulatory, and practical components required for conducting randomised clinical trials. Numerous examples and case studies from industry, academia, and the research literature help readers understand each stage of the clinical trial process.

This second edition contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials. Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies. Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes. Written by an author team with extensive experience in conducting clinical trials, this book:

Randomised Clinical Trials is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting.