clinical trials handbook design and conduct

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Clinical Trials Handbook

Author : Curtis L. Meinert
ISBN : 9781118422793
Genre : Reference
File Size : 48. 6 MB
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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.

Clinical Trials Handbook

Author : Shayne Cox Gad
ISBN : 0470466359
Genre : Science
File Size : 76. 61 MB
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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 Dictionary

Author : Curtis L. Meinert
ISBN : 9781118315286
Genre : Reference
File Size : 82. 17 MB
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A thoroughly updated new edition of the essential reference on the design, practice, and analysis of clinical trials Clinical Trials Dictionary: Terminology and Usage Recommendations, Second Edition presents clear, precise, meticulously detailed entries on all aspects of modern-day clinical trials. Written and compiled by one of the world’s leading clinical trialists, this comprehensive volume incorporates areas of medicine, statistics, epidemiology, computer science, and bioethics—providing a treasure trove of key terms and ideas. This new edition continues to supply readers with the A–Z terminology needed to design, conduct, and analyze trials, introducing a vocabulary for the characterization and description of related features and activities. More than 300 new entries are now included, reflecting the current usage practices and conventions in the field, along with usage notes with recommendations on when to use the term in question. Detailed biographical notes highlight prominent historical figures and institutions in the field, and an extensive bibliography has been updated to provide readers with additional resources for further study. The most up-to-date work of its kind, Clinical Trials Dictionary, Second Edition is an essential reference for anyone who needs to report on, index, analyze, or assess the scientific strength and validity of clinical trials.

Economic Evaluation In Clinical Trials

Author : Henry A. Glick
ISBN : 9780199685028
Genre : Medical
File Size : 34. 93 MB
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It is becoming increasingly important to examine the relationship between the outcomes of a clinical trial and the costs of the medical therapy under study. The results of such analysis can affect reimbursement decisions for new medical technologies, drugs, devices or diagnostics. It can aid companies seeking to make claims about the cost-effectiveness of their product, as well as allowing early consideration of the economic value of therapies which may be important to improving initial adoption decisions. It is also vital for addressing the requirements of regulatory bodies. Economic Evaluation in Clinical Trials provides practical advice on how to conduct cost-effectiveness analyses in controlled trials of medical therapies. This new edition has been extensively rewritten and revised; topics discussed range from design issues such as the types of services that should be measured and price weights, to assessment of quality-adjusted life years. Illustrative materials, case histories and worked examples are included to encourage the reader to apply the methods discussed. These exercises are supported with datasets, programmes and solutions made available online.

Handbook For Clinical Trials Of Imaging And Image Guided Interventions

Author : Nancy A. Obuchowski
ISBN : 9781118849569
Genre : Medical
File Size : 80. 30 MB
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Handbook for Clinical Trials of Imaging and Image-Guided Interventions is the first single-source, multi-disciplinary reference, based on the didactic sessions presented at the annual ‘Clinical Trials Methodology Workshop’ for radiologists, radiation oncologists and imaging scientists (sponsored by the Radiological Society of North America (RSNA)). It focuses on educating radiologists, radiation oncologists and those involved in imaging research with how to design and conduct clinical trials to evaluate imaging technology and imaging biomarkers. The internationally renowned contributors take a broad approach, starting with principles of technology assessment, and then move into specific topics covering the clinical trials of therapy and clinical research in imaging guided interventions including radiotherapy. They discuss the use of imaging as a predictor of therapeutic response, screening trial design, and the practicalities of how to run an efficient clinical trial and good working practices. Later chapters provide a comprehensive array of quantitative methods including: an introduction to statistical considerations in study design, biostatistical analysis methods and their role in clinical imaging research, methods for quantitative imaging biomarker studies, and an introduction to cost effectiveness analysis. Handbook for Clinical Trials of Imaging and Image-Guided Interventions will educate and prepare radiologists at all levels and in all capacities in planning and conducting clinical imaging trials.

Design And Analysis Of Clinical Trials

Author : Shein-Chung Chow
ISBN : 0471249858
Genre : Mathematics
File Size : 71. 26 MB
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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.


Author : Curtis L. Meinert
ISBN : 9780195387889
Genre : Medical
File Size : 26. 13 MB
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The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials.

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