Sharing Clinical Trial Data

Sharing Clinical Trial Data
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 236
Release: 2015-04-20
Genre: Medical
ISBN: 0309316324

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.

Endoscopy in Inflammatory Bowel Disease

Endoscopy in Inflammatory Bowel Disease
Author: Richard Kozarek
Publisher: Springer
Total Pages: 337
Release: 2014-11-03
Genre: Medical
ISBN: 3319110772

This book conjoins the latest advances on the use of endoscopy to diagnose, monitor, and treat patients with inflammatory bowel disease. Chapters include the historical use of rigid sigmoidoscopy, non-interventional imaging procedures, and the correlation of pathology and endoscopic visualization. This is the first book to include individual chapters in gastroenterology, colorectal surgery, and IBD texts, the preeminent role of endoscopic imaging in the management of chronic ulcerative colitis, and Crohn's disease. It also includes chapters on capsule endoscopy and balloon and overtube-assisted enteroscopy to define the presence and activity of Crohn's enteritis and additional chapters defining the use of random biopsies versus chromoendoscopy, and computer enhanced imaging to define possible dysplasia development. The book also includes access to online videos, making it the ultimate verbal and visual tool for all medical professionals interested in the advances in the field over the last several decades. Endoscopy in Inflammatory Bowel Disease is a concise text that is of great value to practicing endoscopists, gastroenterologists, general or colorectal surgeons, physicians in training, and all medical professionals caring for patients with inflammatory bowel disease.

Advances in Inflammatory Bowel Diseases

Advances in Inflammatory Bowel Diseases
Author: P. Rutgeerts
Publisher: Springer Science & Business Media
Total Pages: 340
Release: 1998-12-31
Genre: Medical
ISBN: 9780792387503

Ulcerative colitis and Crohn's disease remain a great therapeutic challenge to the medical community. In recent years knowledge about the pathogenesis of these diseases has progressed rapidly but the cause of the diseases remains completely unknown. It has become clear that dysregulation of the mucosal immune system is the basis for the chronic evolution of the diseases in a genetically susceptible population. Exciting new therapeutic approaches have been attempted in the last couple of years and cytokine and anti-cytokine treatments in particular seem very promising, especially in intractable disease. The format of the Falk Symposium 106 on `Advances in Inflammatory Bowel Diseases', held in Brussels, Belgium, June 18-20, 1998, was somewhat innovative as each session attempted to link the new insights into pathogenetic mechanisms with new therapeutic approaches, resulting in optimal information transfer. The classic therapeutic schemes were updated with a special focus on step-wise build-up of therapy.

Interventional Inflammatory Bowel Disease: Endoscopic Management and Treatment of Complications

Interventional Inflammatory Bowel Disease: Endoscopic Management and Treatment of Complications
Author: Bo Shen
Publisher: Academic Press
Total Pages: 382
Release: 2018-01-16
Genre: Medical
ISBN: 0128113898

Interventional Inflammatory Bowel Diseases: Endoscopic Management and Treatment of Complications covers the preparation, principle, techniques, and damage control of complications in endoscopic therapy, providing the ultimate guidance in endoscopic management of IBD. With contributions from a panel of international leading experts in the field, perspectives are included from GI pathologists, GI radiologists, gastroenterologists, advanced endoscopists, IBD specialists and colorectal surgeons. Recommendations from experts are also included within each chapter. By bridging medical and surgical treatment modalities for IBD, this is the perfect reference for GI researchers, medical students, therapeutic GI endoscopists, IBD specialists, surgeons and advanced health care providers. - Incorporates state-of-the-art of research in the area of therapeutic endoscopy in Crohn's Disease and Ulcerative Colitis - Makes the connection between the understanding of the complex nature and disease course of IBD with corresponding advanced endoscopic procedures - Explores endoscopic treatment as the missing link between medical and surgical treatment for complex Crohn's Disease and Ulcerative Colitis - Contains access to videos demonstrating important procedural concepts

Crohn's Disease and Ulcerative Colitis

Crohn's Disease and Ulcerative Colitis
Author: Daniel C. Baumgart
Publisher: Springer
Total Pages: 671
Release: 2017-03-01
Genre: Medical
ISBN: 3319337033

This new edition is a unique combined resource for physicians and scientists addressing the needs of both groups. In addition to stimulating exchange and collaboration and shortening the path between discovery and application of new knowledge, the book helps clinicians understand new therapeutic concepts from their origins. The volume serves as a comprehensive guide to the current diagnostic modalities, including enhanced imaging techniques such as MRI and CT enterography, virtual colonoscopy, ultrasound, and endomicroscopy, as well as conventional and complex immunomodulatory principles. The latest edition also includes revised chapters from the previous edition, as well as new chapters reflecting current developments in the field. Written by experts in their field, Crohn’s Disease and Ulcerative Colitis: From Epidemiology and Immunobiology to a Rational Diagnostic and Therapeutic Approach, Second Edition is of great value to gastroenterologists, surgeons, internists, pediatricians and gynecologists trainees, as well as all those involved in Crohn’s disease, ulcerative colitis, and related autoimmune disorders.

Anemia in Inflammatory Bowel Diseases

Anemia in Inflammatory Bowel Diseases
Author: Christoph Gasche
Publisher: Uni-Med
Total Pages: 95
Release: 2008
Genre: Anemia
ISBN: 9781848151246

Inflammatory bowel diseases are increasingly common and complex. Modern therapeutic strategies involve infusion therapy and the use anti-TNF or other biologicals as well as intravenous iron preparations. This book covers the pathophysiology and treatment of anemia in inflammatory bowel diseases and discusses controversial aspects specifically when it comes to iron therapy.

Mastery of IBD Surgery

Mastery of IBD Surgery
Author: Neil Hyman
Publisher: Springer
Total Pages: 400
Release: 2019-05-29
Genre: Medical
ISBN: 3030167550

This book provides a guide to the management of patients with Crohn’s disease and ulcerative colitis. The indications for surgery within inflammatory bowel disease are covered, as well as new biologic medications and the effects they have on the immune system. Details on how these drugs should be managed to avoid complications and ensure patient safety are also included. Mastery of IBD Surgery sets out to cover surgical responses to inflammatory bowel disease from a multidisciplinary perspective and aims to help all surgeons and medical professionals working in this area. This book is relevant to colorectal surgeons, gastrointestinal surgeons, and gastroenterologists.

Mucosal Vaccines

Mucosal Vaccines
Author: Hiroshi Kiyono
Publisher: Elsevier
Total Pages: 501
Release: 1996-10-23
Genre: Medical
ISBN: 0080537057

This comprehensive, authoritative treatise covers all aspects of mucosal vaccines including their development, mechanisms of action, molecular/cellular aspects, and practical applications. The contributing authors and editors of this one-of-a-kind book are very well known in their respective fields. Mucosal Vaccines is organized in a unique format in which basic, clinical, and practical aspects of the mucosal immune system for vaccine development are described and discussed. This project is endorsed by the Society for Mucosal Immunology. - Provides the latest views on mucosal vaccines - Applies basic principles to the development of new vaccines - Links basic, clinical, and practical aspects of mucosal vaccines to different infectious diseases - Unique and user-friendly organization

Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
Total Pages: 385
Release: 2014-04-01
Genre: Medical
ISBN: 1587634333

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.