Sharing Clinical Trial Data

Sharing Clinical Trial Data PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236

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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.

Sharing Clinical Trial Data

Sharing Clinical Trial Data PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236

Get Book Here

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.

Journal of the National Cancer Institute

Journal of the National Cancer Institute PDF Author:
Publisher:
ISBN:
Category : Cancer
Languages : en
Pages : 128

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Book Description


Long-Term Ecological Research

Long-Term Ecological Research PDF Author: Michael R. Willig
Publisher: Oxford University Press
ISBN: 0190614102
Category : Science
Languages : en
Pages : 465

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Book Description
The Long-Term Ecological Research (LTER) Program is, in a sense, an experiment to transform the nature of science, and represents one of the most effective mechanisms for catalyzing comprehensive site-based research that is collaborative, multidisciplinary, and long-term in nature. The scientific contributions of the Program are prodigious, but the broader impacts of participation have not been examined in a formal way. This book captures the consequences of participation in the Program on the perspectives, attitudes, and practices of environmental scientists. The edited volume comprises three sections. The first section includes two chapters that provide an overview of the history, goals, mission, and inner workings of the LTER network of sites. The second section comprises three dozen retrospective essays by scientists, data managers or educators who represent a broad spectrum of LTER sites from deserts to tropical forests and from arctic to marine ecosystems. Each essay addresses the same series of probing questions to uncover the extent to which participation has affected the ways that scientists conduct research, educate students, or provide outreach to the public. The final section encompasses 5 chapters, whose authors are biophysical scientists, historians, behavioral scientists, or social scientists. This section analyzes, integrates, or synthesizes the content of the previous chapters from multiple perspectives and uncovers emergent themes and future directions.

Research Awards Index

Research Awards Index PDF Author:
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 616

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Book Description


Principles and Practice of Clinical Trials

Principles and Practice of Clinical Trials PDF Author: Steven Piantadosi
Publisher: Springer Nature
ISBN: 3319526367
Category : Medical
Languages : en
Pages : 2573

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Book Description
This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Ryan's Retina E-Book

Ryan's Retina E-Book PDF Author: SriniVas R. Sadda
Publisher: Elsevier Health Sciences
ISBN: 0323722148
Category : Medical
Languages : en
Pages : 2949

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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.

A History of Farming Systems Research

A History of Farming Systems Research PDF Author: Michael P. Collinson
Publisher: CABI
ISBN: 184593301X
Category : Technology & Engineering
Languages : en
Pages : 450

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Book Description
This book provides a detailed history of Farming Systems Research (FSR). While it includes the application of FSR to developed country agriculture, its main focus is on FSR in its original role, with small-scale, resource-poor farmers in less developed countries.

The Massachusetts General Hospital Guide to Depression

The Massachusetts General Hospital Guide to Depression PDF Author: Benjamin G. Shapero
Publisher: Springer
ISBN: 3319972413
Category : Medical
Languages : en
Pages : 263

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Book Description
Major Depressive Disorder (MDD) is one of the most prevalent psychiatric disorders, with a lifetime prevalence rate of roughly 20%. MDD is a leading cause of disability and premature death worldwide, leads to greater impairment in work functioning than other chronic medical conditions, and has an estimated annual cost of $210 billion in the US. The proposed text is designed for mental health professionals and will present state-of-the-art treatment options that are used in the Depression Clinical and Research Program (DCRP) at the Massachusetts General Hospital. The text provides different treatment options so that providers can ‘think outside the box’ of conventional interventions. The introductory sections discuss general themes about diagnosing and treating depression. The major body of the book, however, consists of chapters organized under the topics of new medication, new psychotherapy, alternative treatments, and consideration of specific populations and how to modify interventions to best treat these patients. Each chapter begins with a case vignette to illustrate key characteristics of the disorder process or treatment and reviews the history, research support, and new advances of these topics. In addition, the chapters include a description of how to apply this topic in treatment and frequently asked questions and answers. This book will be a unique contribution to the field. Existing guides focus on individual treatments of Depression, or include brief descriptions of interventions as a whole. The DCRP has consistently been a forerunner of clinical treatments for depression and often treats challenging cases of this disorder. This book will provide a practical and useful resource with wide applicability.

Impacts of Public-Private Collaborative Research on Alzheimer's Disease: The Case of the Innovative Medicines Initiative

Impacts of Public-Private Collaborative Research on Alzheimer's Disease: The Case of the Innovative Medicines Initiative PDF Author: Elisabetta Vaudano
Publisher: Frontiers Media SA
ISBN: 2832538703
Category : Medical
Languages : en
Pages : 123

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Book Description


Cochrane Handbook for Systematic Reviews of Interventions

Cochrane Handbook for Systematic Reviews of Interventions PDF Author: Julian P. T. Higgins
Publisher: Wiley
ISBN: 9780470699515
Category : Medical
Languages : en
Pages : 672

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Book Description
Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research-based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com). The Cochrane Handbook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves.