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A Manager S Guide To The Design And Conduct Of Clinical Trials

Author : Phillip I. Good
ISBN : 9780471930877
Genre : Mathematics
File Size : 69.14 MB
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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
Category: Mathematics

Oncology Clinical Trials

Author : Susan Halabi, PhD
ISBN : 1935281763
Genre : Medical
File Size : 46.33 MB
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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
Category: Medical

Encyclopedia Of Health Services Research

Author : Ross M. Mullner
ISBN : 9781452266114
Genre : Medical
File Size : 30.51 MB
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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.
Category: Medical

Clinical Trials Handbook

Author : Curtis L. Meinert
ISBN : 9781118422793
Genre : Medical
File Size : 62.78 MB
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A systematic approach to all aspects of designing andconducting clinical trials The success or failure of clinical trials hinges on hundreds ofdetails that need to be developed, often under less than idealconditions. Written by one of the world's leading trialists,Clinical Trials Handbook: Design and Conduct providesclinicians with a complete guide to designing, conducting, andevaluating clinical trials—teaching them how to simplify theprocess and avoid costly mistakes. The author draws on his extensive clinical trials experience tooutline all steps employed in setting up and running clinicaltrials, from budgeting and fundraising to publishing the results.Along the way, practical advice is offered while also addressing amix of logistical, ethical, psychological, behavioral, andadministrative issues inherent to clinical trials. Topics ofcoverage include: Protocols for drug masking, controls, and treatmentrandomization Consent, enrollment, eligibility, and follow-up procedures Different types of sample size design and data collection andprocessing Working with study centers, research staff, and variouscommittees Monitoring treatment effects and performance, and ensuringquality control Data analysis and access policies for study data anddocuments Clinical Trials Handbook is invaluable for practicingclinicians and trialists who would like to learn more about orimprove their understanding of the design and execution of clinicaltrials. The book is also an excellent supplement for courses onclinical trials at the graduate level.
Category: Medical

Rheumatoid Arthritis E Book

Author : Marc C. Hochberg
ISBN : 9780323071024
Genre : Medical
File Size : 52.4 MB
Format : PDF, ePub
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First Prize, Orthopaedics and Rheumatology, BMA Awards 2009 This state-of-the-art reference provides current insights into the etiology, diagnosis and management of rheumatoid arthritis. Leading international authorities in RA examine all of the latest scientific and clinical developments in understanding and managing this challenging disease, including new concepts in pathogenesis, epidemiology, risk factors, imaging, clinical outcomes and treatment. It’s the guidance you need to offer optimal care to your patients with rheumatoid arthritis. Presents the work of leading international experts in rheumatoid arthritis for guidance you can trust. Provides the very latest understanding of the pathogenesis of rheumatoid arthritis, including molecular pathways/mechanisms, and genetic and environmental factors that instigate and drive the disease. Includes comprehensive coverage of clinical features of rheumatoid arthritis including articular, peri-articular and extra-articular manifestations, comorbidities, and outcome measures—disease activity, joint assessment, imaging, and more—for expert diagnosis and monitoring of disease progression. Examines evidence-based treatment options—including traditional and biologic DMARDs and combination therapies—as well as promising therapies on the horizon, placing up-to-date guidance on disease modifying or disease controlling agents at your fingertips.
Category: Medical

Management Of Data In Clinical Trials

Author : Eleanor McFadden
ISBN : 0470181273
Genre : Mathematics
File Size : 47.45 MB
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A valuable new edition of the trusted, practical guide to managing data in clinical trials Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided. While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements. Newly featured topics include: The growing availability of "off-the-shelf" solutions for clinical trials Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry The increasing use of the Internet in the collection of data and management of trials Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines Development of Standard Operating Procedures for the conduct of clinical trials Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.
Category: Mathematics

A Biotech Manager S Handbook

Author : M O'Neill
ISBN : 9781908818157
Genre : Science
File Size : 27.44 MB
Format : PDF
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A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur. No other 'how to' manual exists for this sector Written by a range of expert professionals in each area, all in one book Is the only 'bench to bedside' book covering the whole spectrum of development
Category: Science

A Practical Guide To Managing Clinical Trials

Author : JoAnn Pfeiffer
ISBN : 9781315299778
Genre : Mathematics
File Size : 48.78 MB
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A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Category: Mathematics

Management Of Breast Diseases

Author : Ismail Jatoi
ISBN : 3540697438
Genre : Medical
File Size : 41.12 MB
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In 2002, Lippincott published the Manual of Breast Diseases, edited by Professor Ismail Jatoi. The current book, Management of Breast Diseases, is an adaptation of that manual, with Professor Manfred Kaufmann of the Goethe-University of Frankfurt serving as co-editor. Most of the chapters from the original manual have been either extensively revised or discarded, and several new chapters added. This text contains more material than the original manual, but it is still intended as a basic guide for the wide spectrum of clinicians (surgeons, gynecologists, oncologists, radiation onco- gists, internists, general practitioners) who treat breast diseases, both benign and malignant. To compile this text, we assembled experts from throughout the world. Thus, this text provides not only a broad overview of breast diseases, but also highlights diff- ent perspectives from different parts of the world. Yet, it is worth noting that the management of breast cancer is now largely predicated on evidence-based medicine. Several large, randomized prospective trials have demonstrated the ef? cacy of breast cancer screening and chemoprevention. Other large trials have addressed the impact of systemic therapy, radiotherapy, and variations in local therapy on breast cancer mortality. Many of these landmark trials are discussed in this text, and they clearly have had a bene? cial effect. Indeed, since about 1990, breast cancer mortality rates have declined substantially in most industrialized countries, and this trend is expected to continue in the years ahead.
Category: Medical