A Manager S Guide To The Design And Conduct Of Clinical Trials
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A Manager S Guide To The Design And Conduct Of Clinical Trials
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Author : Phillip I. Good
language : en
Publisher: John Wiley & Sons
Release Date : 2006-04-28
A Manager S Guide To The Design And Conduct Of Clinical Trials written by Phillip I. Good and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-04-28 with Mathematics categories.
This newly updated edition of the benchmark guide tocomputer-assisted clinical trials provides a comprehensive primerfor prospective managers. It covers every critical issue of thedesign and conduct of clinical trials, including study design,organization, regulatory agency liaison, data collection andanalysis, as well as recruitment, software, monitoring, andreporting. Keeping the same user-friendly format as the original, this SecondEdition features new examples and the latest developments inregulatory guidelines, such as e-submission procedures andcomputerized direct data acquisition. The new edition also reflectsthe increasing globalization of clinical trial activities, andincludes new information about international standards andprocedures, including the Common Technical Document and CDISCstandards. This step-by-step guide is supported by handy checklists andextracts from submitted protocols. Experienced author andconsultant Phillip Good incorporateshumorous yet instructiveanecdotes to illustrate common pitfalls. Based on the provenindustrial formula of planning, implementing, and finallyperforming essential checks, the book's three sections-"Plan,""Do," and "Check"-includethe following material: * Should the trials be conducted? * Put it in the computer and keep it there * Staffing for success * Designing trials and determining sample size * Budgeting * Recruiting and retaining patients and physicians * Data management * Monitoring the trials * Data analysis * After action review * Exception handling Executive and managerial professionals involved in the design andanalysis of clinical experiments, along with clinical researchassociates, biostatisticians, and students in public health willfind A Manager's Guide an indispensable resource. Praise for the First Edition: ". . . readable, informative and at times witty . . . never stopsbeing concise and well written . . . a book worth a read . .." -Statistics in Medicine "The book is very prescriptive and full of lists and tables withwhich to guide managers in making effective decisions in usingcomputer-assisted clinical trials in pharmaceutical studies."-Technometrics "This book is must-have reading for anyone in the business . .." -Clinical Chemistry
A Manager S Guide To The Design And Conduct Of Clinical Trials
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Author : Phillip I. Good
language : en
Publisher: John Wiley & Sons
Release Date : 2003-05-14
A Manager S Guide To The Design And Conduct Of Clinical Trials written by Phillip I. Good and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-05-14 with Mathematics categories.
This engaging and non-technical guide to clinical trials covers issues study design, organization, management, analysis, recruitment, reporting, software, and monitoring. Free from the jargon-laden treatment of other books, A Manager’s Guide to the Design and Conduct Clinical Trials is built upon the formula of first planning, then implementing, and finally performing essential checks. Offers an executive level presentation of managerial guidelines as well as handy checklists accompanied by extracts from submitted protocols Includes checklists, examples, and tips, as well as a useful appendix on available software Covers e-submissions and use of computers for direct data acquisition Incorporates humorous yet instructive and true anecdotes to illustrate common pitfalls
Clinical Trials
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Author : Duolao Wang
language : en
Publisher: Remedica
Release Date : 2006
Clinical Trials written by Duolao Wang and has been published by Remedica this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006 with Medical categories.
This book explains statistics specifically for a medically literate audience. Readers gain not only an understanding of the basics of medical statistics, but also a critical insight into how to review and evaluate clinical trial evidence.
Clinical Trials Handbook
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Author : Shayne Cox Gad
language : en
Publisher: John Wiley & Sons
Release Date : 2009-06-17
Clinical Trials Handbook written by Shayne Cox Gad and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-06-17 with Science categories.
Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
Clinical Trials Handbook
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Author : Curtis L. Meinert
language : en
Publisher: John Wiley & Sons
Release Date : 2012-10-10
Clinical Trials Handbook written by Curtis L. Meinert and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-10-10 with Reference categories.
A 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.
Oncology Clinical Trials
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Author : Susan Halabi
language : en
Publisher: Demos Medical Publishing
Release Date : 2009-12-22
Oncology Clinical Trials written by Susan Halabi and has been published by Demos Medical Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-12-22 with Medical categories.
Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout
Clinical Trials
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Author : Stuart J. Pocock
language : en
Publisher: John Wiley & Sons
Release Date : 2013-07-17
Clinical Trials written by Stuart J. Pocock and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-07-17 with Medical categories.
This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience.
Encyclopedia Of Health Services Research
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Author : Ross M. Mullner
language : en
Publisher: SAGE Publications
Release Date : 2009-05-15
Encyclopedia Of Health Services Research written by Ross M. Mullner and has been published by SAGE Publications this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-05-15 with Medical categories.
Today, as never before, healthcare has the ability to enhance the quality and duration of life. At the same time, healthcare has become so costly that it can easily bankrupt governments and impoverish individuals and families. Health services research is a highly multidisciplinary field, including such areas as health administration, health economics, medical sociology, medicine, , political science, public health, and public policy. The Encyclopedia of Health Services Research is the first single reference source to capture the diversity and complexity of the field. With more than 400 entries, these two volumes investigate the relationship between the factors of cost, quality, and access to healthcare and their impact upon medical outcomes such as death, disability, disease, discomfort, and dissatisfaction with care. Key Features Examines the growing healthcare crisis facing the United States Encompasses the structure, process, and outcomes of healthcare Aims to improve the equity, efficiency, effectiveness, and safety of healthcare by influencing and developing public policies Describes healthcare systems and issues from around the globe Key Themes Access to Care Accreditation, Associations, Foundations, and Research Organizations Biographies of Current and Past Leaders Cost of Care, Economics, Finance, and Payment Mechanisms Disease, Disability, Health, and Health Behavior Government and International Healthcare Organizations Health Insurance Health Professionals and Healthcare Organizations Health Services Research Laws, Regulations, and Ethics Measurement; Data Sources and Coding; and Research Methods Outcomes of Care Policy Issues, Healthcare Reform, and International Comparisons Public Health Quality and Safety of Care Special and Vulnerable Groups The Encyclopedia is designed to be an introduction to the various topics of health services research for an audience including undergraduate students, graduate students, andgeneral readers seeking non-technical descriptions of the field and its practices. It is also useful for healthcare practitioners wishing to stay abreast of the changes and updates in the field.
Research Methods In Psychiatry
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Author : Chris Freeman
language : en
Publisher: RCPsych Publications
Release Date : 2006-12
Research Methods In Psychiatry written by Chris Freeman and has been published by RCPsych Publications this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-12 with Medical categories.
This updated comprehensive guide to psychiatric research methods takes the reader from getting started in research through to publishing a paper, with advice on avoiding common pitfalls along the way. Systematic analysis and meta-analysis, epidemiology, qualitative research, and research focused on a few patients are discussed, together with the principles of validity and reliability in the assessment of psychological variables and statistical aspects of the design and analysis of clinical trials. Five completely new chapters cover topics such as research from the trainee's perspective and research in learning disability and child and adolescent psychiatry. A key text for psychiatric trainees embarking on research projects, this book will also be useful to psychiatrists supervising research projects, and those in the social sciences with an interest in carrying out research or critically reviewing the published evidence. Topics covered include setting up a research project, how to make a comprehensive review of the literature, choosing a rating scale, and getting research published.
Methods In Medical Ethics
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Author : Jeremy Sugarman
language : en
Publisher: Georgetown University Press
Release Date : 2010-10-15
Methods In Medical Ethics written by Jeremy Sugarman and has been published by Georgetown University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-10-15 with Medical categories.
Medical ethics draws upon methods from a wide array of disciplines, including anthropology, economics, epidemiology, health services research, history, law, medicine, nursing, philosophy, psychology, sociology, and theology. In this influential book, outstanding scholars in medical ethics bring these many methods together in one place to be systematically described, critiqued, and challenged. Newly revised and updated chapters in this second edition include philosophy, religion and theology, virtue and professionalism, casuistry and clinical ethics, law, history, qualitative research, ethnography, quantitative surveys, experimental methods, and economics and decision science. This second edition also includes new chapters on literature and sociology, as well as a second chapter on philosophy which expands the range of philosophical methods discussed to include gender ethics, communitarianism, and discourse ethics. In each of these chapters, contributors provide descriptions of the methods, critiques, and notes on resources and training. Methods in Medical Ethics is a valuable resource for scholars, teachers, editors, and students in any of the disciplines that have contributed to the field. As a textbook and reference for graduate students and scholars in medical ethics, it offers a rich understanding of the complexities involved in the rigorous investigation of moral questions in medical practice and research.