As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol. Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores ethnic sensitivity, the necessity of bridging studies, types of bridging studies, and the assessment of similarity between regions based on bridging evidence. For multiregional clinical trials, the text considers regional differences, assesses the consistency of treatment effect across regions, and discusses sample size determination for each region. Taking into account the International Conference Harmonisation (ICH) E5 framework for bridging studies, the book provides a unified summary of the growing literature and research activities in this area. It covers the regulatory requirements, scientific and practical issues, and statistical methodology for designing and evaluating bridging studies and multiregional clinical trials, with the goal of inspiring new research activities in the field.

Presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. Emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references.

This edited volume presents innovative current research in the field of Science Education. The chapter’s deal with a wide variety of topics and research approaches, conducted in a range of contexts and settings. Together they make a strong contribution to knowledge on science teaching and learning. The book consists of selected presentations from the 12th European Science Education Research Association (ESERA) Conference, held in Dublin, Ireland from 21st to 25th August, 2017. The ESERA community is made up of professionals with diverse disciplinary backgrounds from natural sciences to social sciences. This diversity enables a rich understanding of cognitive and affective aspects of science teaching and learning. The studies in this book will stimulate discussion and interest in finding new ways of implementing and researching science education for the future. The twenty-two chapters in this book are presented in four parts highlighting innovative approaches to school science, emerging identities in science education, approaches to developing learning and competence progressions, and ways of enhancing science teacher education. This collection of studies showcases current research orientations in science education and is of interest to science teachers, teacher educators and science education researchers around the world with a commitment to bridging research and practice in science teaching and learning.

In recent years there has been a huge rise in interdisciplinary and multidisciplinary research in animal sciences which has accelerated improvements in animal welfare. Down to earth and practical, this book gives guidance on how cross-disciplinary research can advance animal welfare. The aim of the book is to help researchers and graduate animal science students to understand how to advance animal welfare through the integration of disciplines.

Bridging the gap between research and practice communities is more pertinent than ever because of the need for evidence in developing and evaluating library services and programs. The gap between research and library practice has been discussed in the library and information science (LIS) field for almost two decades. The issues range from limited transfer of ideas from research into practice to a lack of education in research methods for library practitioners. This book introduces new voices from international research and practice communities into the discussion and contributes to the debate about the research-practice divide. Education and continuing training in research methods from international perspectives are explored and the experiences of researcher-practitioners from several countries highlight the issues. The volume includes chapters from LIS educators, academic researchers, and researcher-practitioners from 18 countries. It features the voices of instructors who teach research methods in LIS programs and library practitioners who engage in research. The book is addressed to the global audience of LIS educators and practitioners, with the goal of deepening the understanding of LIS education and training in research methods through sharing case studies and approaches to teaching and conducting research in practice.

Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.

Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against infectious diseases. Avoiding unnecessary mathematical detail, the book covers basic concepts underlying the use of cluster randomisation, such as direct, indirect, and total effects. In the time since the publication of the first edition, the use of cluster randomised trials (CRTs) has increased substantially, which is reflected in the updates to this edition. There are greatly expanded sections on randomisation, sample size estimation, and alternative designs, including new material on stepped wedge designs. There is a new section on handling ordinal outcome data, and an appendix with descriptions and/or generating code of the example data sets. Although the book mainly focuses on medical and public health applications, it shows that the rigorous evidence of intervention effects provided by CRTs has the potential to inform public policy in a wide range of other areas. The book encourages readers to apply the methods to their own trials, reproduce the analyses presented, and explore alternative approaches.

First Published in 2017. Routledge is an imprint of Taylor & Francis, an Informa company.

The aim of this book is to equip biostatisticians and other quantitative scientists with the necessary skills, knowledge, and habits to collaborate effectively with clinicians in the healthcare field. The book provides valuable insight on where to look for information and material on sample size and statistical techniques commonly used in clinical research, and on how best to communicate with clinicians. It also covers the best practices to adopt in terms of project, time, and data management; relationship with collaborators; etc.