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Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309316324 Category : Medical Languages : en Pages : 236
Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309316324 Category : Medical Languages : en Pages : 236
Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author: Curtis L. Meinert Publisher: John Wiley & Sons ISBN: 1118422791 Category : Reference Languages : en Pages : 469
Book Description
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.
Author: Richard Wormald Publisher: John Wiley & Sons ISBN: 0470698152 Category : Medical Languages : en Pages : 376
Book Description
Evidence-Based Ophthalmology offers a unique approach to managing eye disease. From systematic reviewing of evidence, this book provides an overview of techniques for optimum management in key areas, including glaucoma, cataract and retinal disease – an invaluable reference source for practitioners worldwide representing an important contribution to the literature. Key Features International authorship by leading Cochrane participants An unbiased method for summarising and disseminating the evidence Identifies gaps in evidence, and therefore research opportunities Free-access update website giving the latest trial data and recommendations for implementation in practice Includes a free fully searchable CD-ROM
Author: Shayne Cox Gad Publisher: John Wiley & Sons ISBN: 0470466359 Category : Science Languages : en Pages : 1247
Book Description
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.
Author: Stephen J. Ryan Publisher: Elsevier Health Sciences ISBN: 1455707376 Category : Retina Languages : en Pages : 2498
Book Description
Unequalled in scope, depth, and clinical precision, Retina, 5th Edition keeps you at the forefront of today's new technologies, surgical approaches, and diagnostic and therapeutic options for retinal diseases and disorders. Comprehensively updated to reflect everything you need to know regarding retinal diagnosis, treatment, development, structure, function, and pathophysiology, this monumental ophthalmology reference work equips you with expert answers to virtually any question you may face in practice. Benefit from the extensive knowledge and experience of esteemed editor Dr. Stephen Ryan, five expert co-editors, and a truly global perspective from 358 other world authorities across Europe, Asia, Australasia the Americas.Examine and evaluate the newest diagnostic technologies and approaches that are changing the management of retinal disease, including future technologies which will soon become the standard.Put the very latest scientific and genetic discoveries, diagnostic imaging methods, drug therapies, treatment recommendations, and surgical techniques to work in your practice.
Author: SriniVas R. Sadda Publisher: Elsevier Health Sciences ISBN: 0323722148 Category : Medical Languages : en Pages : 2949
Book Description
Through six outstanding and award-winning editions, Ryan's Retina has offered unsurpassed coverage of this complex subspecialty—everything from basic science through the latest research, therapeutics, technology, and surgical techniques. The fully revised 7th Edition, edited by Drs. SriniVas R. Sadda, Andrew P. Schachat, Charles P. Wilkinson, David R. Hinton, Peter Wiedemann, K. Bailey Freund, and David Sarraf, continues the tradition of excellence, balancing the latest scientific research and clinical correlations and covering everything you need to know on retinal diagnosis, treatment, development, structure, function, and pathophysiology. More than 300 global contributors share their knowledge and expertise to create the most comprehensive reference available on retina today. - Features sweeping content updates, including new insights into the fundamental pathogenic mechanisms of age-related macular degeneration, advances in imaging including OCT angiography and intraoperative OCT, new therapeutics for retinal vascular disease and AMD, novel immune-based therapies for uveitis, and the latest in instrumentation and techniques for vitreo-retinal surgery. - Includes five new chapters covering Artificial Intelligence and Advanced Imaging Analysis, Pachychoroid Disease and Its Association with Polypoidal Choroidal Vasculopathy, Retinal Manifestations of Neurodegeneration, Microbiome and Retinal Disease, and OCT-Angiography. - Includes more than 50 video clips (35 new to this edition) highlighting the latest surgical techniques, imaging guidance, and coverage of complications of vitreoretinal surgery. New videos cover Scleral Inlay for Recurrent Optic Nerve Pit Masculopathy, Trauma with Contact Lens, Recurrent Retinal Detachment due to PVR, Asteroid Hyalosis, and many more. - Contains more than 2,000 high-quality images (700 new to this edition) including anatomical illustrations, clinical and surgical photographs, diagnostic imaging, decision trees, and graphs. - Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all of the text, figures, and references from the book on a variety of devices.
Author: Institute of Medicine
Author: Institute of Medicine
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Author: 
Author: Curtis L. Meinert
Author: Richard Wormald
Author: Shayne Cox Gad
Author: Stephen J. Ryan
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Author: New Orleans Academy of Ophthalmology. Session
Author: SriniVas R. Sadda