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Global New Drug Development: An Introduction (Postgraduate Pharmacy Series)
by Jan A. Rosier Mark A. Martens Josse R. ThomasThe development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market. This book offers an introduction to the field of drug development with a clear overview of the different processes that lead to a successful new medicine and of the regulatory pathways that are used to launch a new drug that are both safe and efficacious. "This is the most comprehensive and detailed book on drug development I have ever read and I feel that it is likely to become a staple of drug development courses, such as those taught at Masters Level in my own University.... I think in the light of increasing integration of company and academic approaches to drug development both sides can read this book... (and, therefore)... this book could not be more timely."—Professor Mike Coleman, University of Aston, UK ( from his review of the final manuscript)
Global New Drug Development: An Introduction (Postgraduate Pharmacy Series)
by Jan A. Rosier Mark A. Martens Josse R. ThomasThe development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market. This book offers an introduction to the field of drug development with a clear overview of the different processes that lead to a successful new medicine and of the regulatory pathways that are used to launch a new drug that are both safe and efficacious. "This is the most comprehensive and detailed book on drug development I have ever read and I feel that it is likely to become a staple of drug development courses, such as those taught at Masters Level in my own University.... I think in the light of increasing integration of company and academic approaches to drug development both sides can read this book... (and, therefore)... this book could not be more timely."—Professor Mike Coleman, University of Aston, UK ( from his review of the final manuscript)
Transdisciplinary Public Health: Research, Education, and Practice (Jossey-Bass Public Health #49)
by Debra Haire-Joshu Timothy D. McBride"This book makes a great leap in the conceptualization of transdisciplinary approaches, as well as provides concrete examples in practice, teaching, policy, and research." —From the Foreword by Edward F. Lawlor, dean and the William E. Gordon Distinguished Professor, the Brown School; and founding director, Institute for Public Health at Washington University in St. Louis The complexity of public health and social problems is becoming more challenging. Understanding and designing solutions for these problems requires perspectives from multiple disciplines and fields as well as cross-disciplinary research and practice teams. Transdisciplinary Public Health fills a void in the literature and offers a comprehensive text that introduces transdisciplinary methods as a means for providing an innovative tool set for problem-solving in public health research and practice. With contributions from leading experts, Transdisciplinary Public Health offers an understanding of interactions among the biological, behavioral, social, and public health sciences; shared disciplinary frameworks in analyzing health problems; and the integration and evaluation of transdisciplinary solutions to alleviate complex public health issues. Use of this important resource will promote transdisciplinary research and practice, resulting in novel solutions that positively impact human health.
The U.S. Healthcare System: Origins, Organization and Opportunities
by Joel I. ShalowitzProvides a diverse, multi-faceted approach to health care evaluation and management The U.S. Health Care System: Origins, Organization and Opportunities provides a comprehensive introduction and resource for understanding healthcare management in the United States. It brings together the many “moving parts” of this large and varied system to provide both a bird’s-eye view as well as relevant details of the complex mechanisms at work. By focusing on stakeholders and their interests, this book analyzes the value propositions of the buyers and sellers of healthcare products and services along with the interests of patients. The book begins with a presentation of frameworks for understanding the structure of the healthcare system and its dynamic stakeholder inter-relationships. The chapters that follow each begin with their social and historical origins, so the reader can fully appreciate how that area evolved. The next sections on each topic describe the current environment and opportunities for improvement. Throughout, the learning objectives focus on three areas: frameworks for understanding issues, essential factual knowledge, and resources to keep the reader keep up to date. Healthcare is a rapidly evolving field, due to the regulatory and business environments as well as the advance of science. To keep the content current, online updates are provided at: www.HealthcareInsights.MD. This website also offers a weekday blog of important/interesting news and teaching notes/class discussion suggestions for instructors who use the book as a text. The U.S. Health Care System: Origins, Organization and Opportunities is an ideal textbook for healthcare courses in MBA, MPH, MHA, and public policy/administration programs. In piloting the content, over the past several years the author has successfully used drafts of chapters in his Healthcare Systems course for MBA and MPH students at Northwestern University. The book is also useful for novice or seasoned suppliers, payers and providers who work across the healthcare field and want a wider or deeper understanding of the entire system.
The Student's Guide to Becoming a Midwife
by Ian Peate Cathy HamiltonThe Student’s Guide to Becoming a Midwife is essential reading for all student midwives. Now updated to include the latest 2012 NMC Midwifery Rules and Standards and a brand new chapter on the midwife and public health, this comprehensive resource provides a wide range of need-to-know information for student midwives, including: Effective communication and documentation Confidentiality Interdisciplinary working The fundamentals of antenatal, intrapartum, and postnatal care Assessment and examination of the new-born baby Medicines Public health Clinical decision-making Evidence-based practice With case studies, words of wisdom from current midwives and a range of activities and self-test questions throughout – making it easy to learn and understand key concepts – The Student’s Guide to Becoming a Midwife is the ideal companion for students throughout their course.
Launching and Leading Change Initiatives in Health Care Organizations: Managing Successful Projects (Jossey-Bass Public Health #213)
by David A. ShoreImplement change that fosters sustainable growth and better patient care Health care projects depend on astute management of change. But more than anything else, they depend on leaders who pay attention, who understand the importance of starting right, and who know how to launch projects that succeed. If leaders can increase the percentage of successful projects, patients, and practitioners everywhere will be better off and so will the organizations that depend on these projects for innovation. In Launching and Leading Change Initiatives in Health Care Organizations: Managing Successful Projects. Author David A. Shore of the Harvard School of Public Health speaks directly to the health care leaders and managers who see the need for change, but keep encountering nearly insurmountable challenges. Through his research, Shore discovered that most implementation failures occur because of a poor launch, and that strengthening processes and operations during the early weeks of a new project is a key to continued success. The book covers issues like: The preliminary groundwork that cultivates a stronger launch Systematic and selective project selection Building the team that accomplishes change Skill-building and record-keeping systems that foster sustainable growth Launching and Leading Change Initiatives in Health Care Organizations gives leaders and managers the practical, easy-to-implement ideas and methodologies to start and manage projects successfully.
Roitt's Essential Immunology (Essentials #20)
by Peter J. Delves Seamus J. Martin Dennis R. Burton Ivan M. RoittRoitt's Essential Immunology - the textbook of choice for students and instructors of immunology worldwide Roitt’s Essential Immunology clearly explains the key principles needed by medical and health sciences students, from the basis of immunity to clinical applications. A brand new introduction sets the scene to section 1, Fundamentals of Immunology, introducing the microbial world and the strategies the body employs to defend itself. Each chapter then guides the reader through a different part of the immune system, and explains the role of each cell or molecule individually, and then as a whole. Section 2, Applied Immunology, discusses what happens when things go wrong, and the role the immune system plays alongside the damaging effects of a disease, including cancer, immunodeficiency, allergies and transplantation and the beneficial effects of vaccines. The 13th edition continues to be a user-friendly and engaging introduction to the workings of the immune system, whilst supporting those who require a slightly more detailed understanding of the key developments in immunology. The content has been fully updated throughout and includes: An expansion on key clinical topics, including: innate immunity, autoimmune conditions, asthma, primary immunodeficiency, and HIV/AIDS Beautifully presented with improved artwork and new illustrations A range of learning features, including introduction re-cap boxes, end of chapter and section summaries to aid revision, as well as further reading suggestions, and a glossary to explain the most important immunology terms. Roitt's Essential Immunology is also supported by a companion website at www.roitt.com including: An additional online only chapter on immunological methods and applications Further interactive multiple choice and single best answer questions for each chapter Animations and videos showing key concepts Fully downloadable figures and illustrations, further reading and useful links Updated extracts from the Encyclopaedia of Life Sciences Podcasts to reinforce the key principles explained in the text
Roitt's Essential Immunology (Essentials)
by Peter J. Delves Seamus J. Martin Dennis R. Burton Ivan M. RoittRoitt's Essential Immunology - the textbook of choice for students and instructors of immunology worldwide Roitt’s Essential Immunology clearly explains the key principles needed by medical and health sciences students, from the basis of immunity to clinical applications. A brand new introduction sets the scene to section 1, Fundamentals of Immunology, introducing the microbial world and the strategies the body employs to defend itself. Each chapter then guides the reader through a different part of the immune system, and explains the role of each cell or molecule individually, and then as a whole. Section 2, Applied Immunology, discusses what happens when things go wrong, and the role the immune system plays alongside the damaging effects of a disease, including cancer, immunodeficiency, allergies and transplantation and the beneficial effects of vaccines. The 13th edition continues to be a user-friendly and engaging introduction to the workings of the immune system, whilst supporting those who require a slightly more detailed understanding of the key developments in immunology. The content has been fully updated throughout and includes: An expansion on key clinical topics, including: innate immunity, autoimmune conditions, asthma, primary immunodeficiency, and HIV/AIDS Beautifully presented with improved artwork and new illustrations A range of learning features, including introduction re-cap boxes, end of chapter and section summaries to aid revision, as well as further reading suggestions, and a glossary to explain the most important immunology terms. Roitt's Essential Immunology is also supported by a companion website at www.roitt.com including: An additional online only chapter on immunological methods and applications Further interactive multiple choice and single best answer questions for each chapter Animations and videos showing key concepts Fully downloadable figures and illustrations, further reading and useful links Updated extracts from the Encyclopaedia of Life Sciences Podcasts to reinforce the key principles explained in the text
Thomas' Hematopoietic Cell Transplantation: Stem Cell Transplantation
by Joseph H. Antin Robert S. Negrin Stephen J. Forman Frederick R. AppelbaumFully revised for the fifth edition, this outstanding reference on bone marrow transplantation is an essential, field-leading resource. Extensive coverage of the field, from the scientific basis for stem-cell transplantation to the future direction of research Combines the knowledge and expertise of over 170 international specialists across 106 chapters Includes new chapters addressing basic science experiments in stem-cell biology, immunology, and tolerance Contains expanded content on the benefits and challenges of transplantation, and analysis of the impact of new therapies to help clinical decision-making Includes a fully searchable Wiley Digital Edition with downloadable figures, linked references, and more References for this new edition are online only, accessible via the Wiley Digital Edition code printed inside the front cover or at www.wiley.com/go/forman/hematopoietic.
Health Care Operations and Supply Chain Management: Operations, Planning, and Control
by John F. Kros Evelyn C. BrownHealth Care Operations and Supply Chain Management This innovative text offers a thorough foundation in operations management, supply chain management,?and the strategic implementation of programs, techniques, and tools for reducing costs and improving quality in health care organizations. The authors incorporate the features and functions of Microsoft Excel where appropriate in their coverage of supply chain strategy, process design and analysis of health care operations, managing health care operations quality, and planning and controlling health care operations. Health Care Operations and Supply Chain Management offers real-world examples to illustrate the most current concepts and techniques such as value stream mapping and Six Sigma. In addition, the authors clearly demonstrate how operations and process improvement relate to contemporary health care trends such as evidence-based medicine and pay-for-performance. Health Care Operations and Supply Chain Management contains: Leading edge concepts and techniques Real-life data and actual examples from health care settings to underscore the main concepts in the text Instruction in the use of Microsoft Excel for health care operations and supply side management The book's numerous screen shots and detailed instructions guide the student through the use of Microsoft Excel's many functions and features.
Thomas' Hematopoietic Cell Transplantation: Stem Cell Transplantation
by Joseph H. Antin Robert S. Negrin Stephen J. Forman Frederick R. AppelbaumFully revised for the fifth edition, this outstanding reference on bone marrow transplantation is an essential, field-leading resource. Extensive coverage of the field, from the scientific basis for stem-cell transplantation to the future direction of research Combines the knowledge and expertise of over 170 international specialists across 106 chapters Includes new chapters addressing basic science experiments in stem-cell biology, immunology, and tolerance Contains expanded content on the benefits and challenges of transplantation, and analysis of the impact of new therapies to help clinical decision-making Includes a fully searchable Wiley Digital Edition with downloadable figures, linked references, and more References for this new edition are online only, accessible via the Wiley Digital Edition code printed inside the front cover or at www.wiley.com/go/forman/hematopoietic.
Health Communication: From Theory to Practice (Jossey-Bass Public Health #217)
by Renata SchiavoNow in its second edition, Health Communication: From Theory to Practice provides a comprehensive introduction to theory, intervention design, current issues, and special topics in health communication. The book also represents a hands-on guide to program development, implementation, and evaluation. This second edition further emphasizes the importance of a people-centered and participatory approach to health communication interventions, which takes into account key social determinants of health as well as the interconnection of various health and social fields. While maintaining a strong focus on the importance of behavioral, social, and organizational results as key outcomes of health communication interventions, this second edition also includes new or updated information, theoretical models, resources, and case studies on: Health equity Urban health New media Emergency and risk communication Strategic partnerships in health communication Policy communication and public advocacy Cultural competence Health literacy The evaluation of health communication interventions To access a companion website with instructor resources (PowerPoint presentations for all chapters, sample assignments, and other resources), please visit www.wiley.com/go/schiavo2eThis title is also available as a mobile App from MedHand Mobile Libraries. Buy it now from iTunes, Google Play or the MedHand Store.
Changing the U.S. Health Care System: Key Issues in Health Services Policy and Management (Health Ser.)
by Gerald F. KominskiThe Fourth Edition of Changing the U.S. Health Care System addresses the key topics in health care policy and management, presenting evidence-based views of current issues. Each chapter is written by an expert in the field who integrates evidence to explain the current condition and presents support for needed change. The book examines all the levers in the setting and implementation of health policy, and includes extensive coverage of impact of the Affordable Care Act, particularly on Medicare, Medicaid, and large and small group insurance markets. Also new to this edition is expanded coverage of nursing, disease management, mental health, women's health, children's health, and care for the homeless.
Transdisciplinary Public Health: Research, Education, and Practice (Jossey-Bass Public Health #49)
by Debra Haire-Joshu Timothy D. McBride"This book makes a great leap in the conceptualization of transdisciplinary approaches, as well as provides concrete examples in practice, teaching, policy, and research." —From the Foreword by Edward F. Lawlor, dean and the William E. Gordon Distinguished Professor, the Brown School; and founding director, Institute for Public Health at Washington University in St. Louis The complexity of public health and social problems is becoming more challenging. Understanding and designing solutions for these problems requires perspectives from multiple disciplines and fields as well as cross-disciplinary research and practice teams. Transdisciplinary Public Health fills a void in the literature and offers a comprehensive text that introduces transdisciplinary methods as a means for providing an innovative tool set for problem-solving in public health research and practice. With contributions from leading experts, Transdisciplinary Public Health offers an understanding of interactions among the biological, behavioral, social, and public health sciences; shared disciplinary frameworks in analyzing health problems; and the integration and evaluation of transdisciplinary solutions to alleviate complex public health issues. Use of this important resource will promote transdisciplinary research and practice, resulting in novel solutions that positively impact human health.
The U.S. Healthcare System: Origins, Organization and Opportunities
by Joel I. ShalowitzProvides a diverse, multi-faceted approach to health care evaluation and management The U.S. Health Care System: Origins, Organization and Opportunities provides a comprehensive introduction and resource for understanding healthcare management in the United States. It brings together the many “moving parts” of this large and varied system to provide both a bird’s-eye view as well as relevant details of the complex mechanisms at work. By focusing on stakeholders and their interests, this book analyzes the value propositions of the buyers and sellers of healthcare products and services along with the interests of patients. The book begins with a presentation of frameworks for understanding the structure of the healthcare system and its dynamic stakeholder inter-relationships. The chapters that follow each begin with their social and historical origins, so the reader can fully appreciate how that area evolved. The next sections on each topic describe the current environment and opportunities for improvement. Throughout, the learning objectives focus on three areas: frameworks for understanding issues, essential factual knowledge, and resources to keep the reader keep up to date. Healthcare is a rapidly evolving field, due to the regulatory and business environments as well as the advance of science. To keep the content current, online updates are provided at: www.HealthcareInsights.MD. This website also offers a weekday blog of important/interesting news and teaching notes/class discussion suggestions for instructors who use the book as a text. The U.S. Health Care System: Origins, Organization and Opportunities is an ideal textbook for healthcare courses in MBA, MPH, MHA, and public policy/administration programs. In piloting the content, over the past several years the author has successfully used drafts of chapters in his Healthcare Systems course for MBA and MPH students at Northwestern University. The book is also useful for novice or seasoned suppliers, payers and providers who work across the healthcare field and want a wider or deeper understanding of the entire system.
Health Care Operations and Supply Chain Management: Operations, Planning, and Control
by John F. Kros Evelyn C. BrownHealth Care Operations and Supply Chain Management This innovative text offers a thorough foundation in operations management, supply chain management,?and the strategic implementation of programs, techniques, and tools for reducing costs and improving quality in health care organizations. The authors incorporate the features and functions of Microsoft Excel where appropriate in their coverage of supply chain strategy, process design and analysis of health care operations, managing health care operations quality, and planning and controlling health care operations. Health Care Operations and Supply Chain Management offers real-world examples to illustrate the most current concepts and techniques such as value stream mapping and Six Sigma. In addition, the authors clearly demonstrate how operations and process improvement relate to contemporary health care trends such as evidence-based medicine and pay-for-performance. Health Care Operations and Supply Chain Management contains: Leading edge concepts and techniques Real-life data and actual examples from health care settings to underscore the main concepts in the text Instruction in the use of Microsoft Excel for health care operations and supply side management The book's numerous screen shots and detailed instructions guide the student through the use of Microsoft Excel's many functions and features.
Changing the U.S. Health Care System: Key Issues in Health Services Policy and Management
by Gerald F. KominskiThe Fourth Edition of Changing the U.S. Health Care System addresses the key topics in health care policy and management, presenting evidence-based views of current issues. Each chapter is written by an expert in the field who integrates evidence to explain the current condition and presents support for needed change. The book examines all the levers in the setting and implementation of health policy, and includes extensive coverage of impact of the Affordable Care Act, particularly on Medicare, Medicaid, and large and small group insurance markets. Also new to this edition is expanded coverage of nursing, disease management, mental health, women's health, children's health, and care for the homeless.
Launching and Leading Change Initiatives in Health Care Organizations: Managing Successful Projects (Jossey-Bass Public Health #213)
by David A. ShoreImplement change that fosters sustainable growth and better patient care Health care projects depend on astute management of change. But more than anything else, they depend on leaders who pay attention, who understand the importance of starting right, and who know how to launch projects that succeed. If leaders can increase the percentage of successful projects, patients, and practitioners everywhere will be better off and so will the organizations that depend on these projects for innovation. In Launching and Leading Change Initiatives in Health Care Organizations: Managing Successful Projects. Author David A. Shore of the Harvard School of Public Health speaks directly to the health care leaders and managers who see the need for change, but keep encountering nearly insurmountable challenges. Through his research, Shore discovered that most implementation failures occur because of a poor launch, and that strengthening processes and operations during the early weeks of a new project is a key to continued success. The book covers issues like: The preliminary groundwork that cultivates a stronger launch Systematic and selective project selection Building the team that accomplishes change Skill-building and record-keeping systems that foster sustainable growth Launching and Leading Change Initiatives in Health Care Organizations gives leaders and managers the practical, easy-to-implement ideas and methodologies to start and manage projects successfully.
Health Communication: From Theory to Practice (Jossey-Bass Public Health)
by Renata SchiavoNow in its second edition, Health Communication: From Theory to Practice provides a comprehensive introduction to theory, intervention design, current issues, and special topics in health communication. The book also represents a hands-on guide to program development, implementation, and evaluation. This second edition further emphasizes the importance of a people-centered and participatory approach to health communication interventions, which takes into account key social determinants of health as well as the interconnection of various health and social fields. While maintaining a strong focus on the importance of behavioral, social, and organizational results as key outcomes of health communication interventions, this second edition also includes new or updated information, theoretical models, resources, and case studies on: Health equity Urban health New media Emergency and risk communication Strategic partnerships in health communication Policy communication and public advocacy Cultural competence Health literacy The evaluation of health communication interventions To access a companion website with instructor resources (PowerPoint presentations for all chapters, sample assignments, and other resources), please visit www.wiley.com/go/schiavo2eThis title is also available as a mobile App from MedHand Mobile Libraries. Buy it now from iTunes, Google Play or the MedHand Store.
Public Health Law Research: Theory and Methods
by Alexander C. Wagneaar Scott C. Burris Alexander C. WagenaarPublic Health Law Research: Theory and Methods definitively explores the mechanisms, theories and models central to public health law research – a growing field dedicated to measuring and studying law as a central means for advancing public health. Editors Alexander C. Wagenaar and Scott Burris outline integrated theory drawn from numerous disciplines in the social and behavioral sciences; specific mechanisms of legal effect and guidelines for collecting and coding empirical datasets of statutory and case law; optimal research designs for randomized trials and natural experiments for public health law evaluation; and methods for qualitative and cost-benefit studies of law.. They also discuss the challenge of effectively translating the results of scientific evaluations into public health laws and highlight the impact of this growing field. “How exactly the law can best be used as a tool for protecting and enhancing the public’s health has long been the subject of solely opinion and anecdote. Enter Public Health Law Research, a discipline designed to bring the bright light of science to the relationships between law and health. This book is a giant step forward in illuminating that subject.” -- Stephen Teret, JD, MPH, Professor, Director, Center for Law and the Public's Health, Johns Hopkins Bloomberg School of Public Health “Wagenaar and Burris bring a dose of much needed rigor to the empirical study of which public health law interventions really matter, and which don’t.” -- Bernard S. Black, JD, Chabraja Professor, Northwestern University Law School and Kellogg School of Management Companion Web site: www.josseybass.com/go/wagenaar
Environmental Health Law: An Introduction
by Russellyn S. Carruth Bernard D. GoldsteinThis important resource offers a comprehensive overview of the major U.S. environmental laws and approaches, strategies, standards, and enforcement techniques by which American law protects our environment and our health. Written for the non-lawyer, the book puts the spotlight on general concepts that go a long way to demystify the American legal system (what law consists of, who makes it, how it is made, and how it is enforced). The authors also introduce the major environmental laws and evaluate issues, controversies and developments in environmental policy.
Environmental Health Law: An Introduction
by Russellyn S. Carruth Bernard D. GoldsteinThis important resource offers a comprehensive overview of the major U.S. environmental laws and approaches, strategies, standards, and enforcement techniques by which American law protects our environment and our health. Written for the non-lawyer, the book puts the spotlight on general concepts that go a long way to demystify the American legal system (what law consists of, who makes it, how it is made, and how it is enforced). The authors also introduce the major environmental laws and evaluate issues, controversies and developments in environmental policy.
Public Health Law Research: Theory and Methods
by Alexander C. Wagenaar Scott BurrisPublic Health Law Research: Theory and Methods definitively explores the mechanisms, theories and models central to public health law research – a growing field dedicated to measuring and studying law as a central means for advancing public health. Editors Alexander C. Wagenaar and Scott Burris outline integrated theory drawn from numerous disciplines in the social and behavioral sciences; specific mechanisms of legal effect and guidelines for collecting and coding empirical datasets of statutory and case law; optimal research designs for randomized trials and natural experiments for public health law evaluation; and methods for qualitative and cost-benefit studies of law.. They also discuss the challenge of effectively translating the results of scientific evaluations into public health laws and highlight the impact of this growing field. “How exactly the law can best be used as a tool for protecting and enhancing the public’s health has long been the subject of solely opinion and anecdote. Enter Public Health Law Research, a discipline designed to bring the bright light of science to the relationships between law and health. This book is a giant step forward in illuminating that subject.” -- Stephen Teret, JD, MPH, Professor, Director, Center for Law and the Public's Health, Johns Hopkins Bloomberg School of Public Health “Wagenaar and Burris bring a dose of much needed rigor to the empirical study of which public health law interventions really matter, and which don’t.” -- Bernard S. Black, JD, Chabraja Professor, Northwestern University Law School and Kellogg School of Management Companion Web site: www.josseybass.com/go/wagenaar
Clinical Trials Handbook: Design and Conduct
by Curtis L. MeinertA systematic approach to all aspects of designing and conducting clinical trials The success or failure of clinical trials hinges on hundreds of details that need to be developed, often under less than ideal conditions. Written by one of the world's leading trialists, Clinical Trials Handbook: Design and Conduct provides clinicians with a complete guide to designing, conducting, and evaluating clinical trials—teaching them how to simplify the process and avoid costly mistakes. The author draws on his extensive clinical trials experience to outline all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. Along the way, practical advice is offered while also addressing a mix of logistical, ethical, psychological, behavioral, and administrative issues inherent to clinical trials. Topics of coverage include: Protocols for drug masking, controls, and treatment randomization Consent, enrollment, eligibility, and follow-up procedures Different types of sample size design and data collection and processing Working with study centers, research staff, and various committees Monitoring treatment effects and performance, and ensuring quality control Data analysis and access policies for study data and documents Clinical Trials Handbook is invaluable for practicing clinicians and trialists who would like to learn more about or improve their understanding of the design and execution of clinical trials. The book is also an excellent supplement for courses on clinical trials at the graduate level.
Clinical Trials Handbook: Design and Conduct
by Curtis L. MeinertA systematic approach to all aspects of designing and conducting clinical trials The success or failure of clinical trials hinges on hundreds of details that need to be developed, often under less than ideal conditions. Written by one of the world's leading trialists, Clinical Trials Handbook: Design and Conduct provides clinicians with a complete guide to designing, conducting, and evaluating clinical trials—teaching them how to simplify the process and avoid costly mistakes. The author draws on his extensive clinical trials experience to outline all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. Along the way, practical advice is offered while also addressing a mix of logistical, ethical, psychological, behavioral, and administrative issues inherent to clinical trials. Topics of coverage include: Protocols for drug masking, controls, and treatment randomization Consent, enrollment, eligibility, and follow-up procedures Different types of sample size design and data collection and processing Working with study centers, research staff, and various committees Monitoring treatment effects and performance, and ensuring quality control Data analysis and access policies for study data and documents Clinical Trials Handbook is invaluable for practicing clinicians and trialists who would like to learn more about or improve their understanding of the design and execution of clinical trials. The book is also an excellent supplement for courses on clinical trials at the graduate level.