Designing And Conducting Translational Research Gastroenterology

Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios

The revised fourth edition of Evidence-Based Gastroenterology and Hepatology continues to provide the most current, evidence-based information for determining the appropriate medical and surgical options for screening for, diagnosing, and treating gastrointestinal conditions. With contributions from an international team of leading experts in the field, the 4th edition includes practical recommendations for the care of individual patients based on the latest scientific evidence.

Since the first edition of Clinical Pancreatology for Practising Gastroenterologists and Surgeons was first published sixteen years ago, the knowledge and clinical management of pancreatic diseases have developed markedly. Thanks to the development of translational research and the “from bench to bedside” concept, much progress from the lab has been applied to clinical practice. Additionally, several highly relevant clinical trials published over the last decade have resulted in the updating and optimisation of clinical guidelines. A new and validated classification of the severity and complications of acute pancreatitis that is firmly rooted in clinical practice has become the basis for the development of minimally invasive approaches to pancreatic necrosis. The etiopathogenic knowledge of chronic pancreatitis and other pancreatopaties, like that associated with diabetes mellitus, has developed significantly. Increased study of cystic pancreatic tumours, which has been reflected in the publication of several guidelines and consensus reports over the last few years, is especially important. Most research efforts have focused on pancreatic cancer, which have led and will further lead to a significant increase in the therapeutic armamentarium against this devastating disease. Finally, many newly published studies have changed the concept, causes, clinical relevance, diagnosis and treatment of exocrine pancreatic insufficiency. Updates based on these developments and more are included in the new edition of Clinical Pancreatology for Practising Gastroenterologists and Surgeons. This new edition of Clinical Pancreatology for Practising Gastroenterologists and Surgeons is a result of the collaboration between the world's leading experts in each area of clinical pancreatology, with the aim of facilitating gastroenterologists, surgeons, oncologists, internists, nutritionists, diabetologists, paediatricians, radiologists, pathologists and other specialists in their daily clinical practice. This book is an indispensable update providing leading knowledge in clinical pancreatology.

Clinical and Translational Science: Principles of Human Research, Second Edition, is the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, a field that is devoted to investigating human health and disease, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. This updated second edition has been prepared with an international perspective, beginning with fundamental principles, experimental design, epidemiology, traditional and new biostatistical approaches, and investigative tools. It presents complete instruction and guidance from fundamental principles, approaches, and infrastructure, especially for human genetics and genomics, human pharmacology, research in special populations, the societal context of human research, and the future of human research. The book moves on to discuss legal, social, and ethical issues, and concludes with a discussion of future prospects, providing readers with a comprehensive view of this rapidly developing area of science. Introduces novel physiological and therapeutic strategies for engaging the fastest growing scientific field in both the private sector and academic medicine Brings insights from international leaders into the discipline of clinical and translational science Addresses drug discovery, drug repurposing and development, innovative and improved approaches to go/no-go decisions in drug development, and traditional and innovative clinical trial designs

In recent years, there have been significant advances both in understanding the mechanisms involved in gastrointestinal mucosal injury and protection, as well as in the development of successful strategies for prevention and treatment of gastrointestinal injury. Nevertheless, many people worldwide still suffer from gastrointestinal damage.This book contains contributions by an international panel of researchers in the form of up-to-date reviews on the mechanisms of gastrointestinal injury and protection. These are complemented by papers discussing how these new findings about cell/tissue injury and cytoprotection/organoprotection can be applied to the prevention and treatment of tissue damage in the gastrointestinal tract. Moreover, the publication includes a special chapter on Andre Robert, who has discovered the phenomenon of gastric cytoprotection.This publication will be of great interest for both basic and clinical researchers in gastroenterology and pharmacology, reviewing the advances made so far and pointing towards future developments.

This book provides a history and discussion of the use of human tissues as an alternative to animal-based testing for assessing the efficacy and safety of new medicines. Beginning by providing a historical background to animal-based testing, this text then describes in detail the issues relating to access to human cells and tissue and the rules and regulations governing their use. The book illustrates what is currently possible in humanising medicines research and development, and suggests more rational and reliable means of developing safe and effective drugs for the future than those on which we currently rely. Early chapters establish the need to generate more data in human-derived test systems, and the need for resources such as tissue banks and standardised processes whilst highlighting the barriers that have prevented such developments so far. Subsequent chapters explore the alternatives to current animal toxicology studies, including stem cells and computational models, with balanced views of the technical challenges and opportunities these offer. In addition, useful information on computational methods and pharmacokinetics are included. This book is an essential read for anyone engaged in translational drug discovery who wishes to consolidate their understanding and broaden their awareness of the key issues involved in accessing primary human tissue and the advantages of doing so.

This book represents the coming together of a number of internationally renowned scholars from science, philosophy, law and social science. Each author presents a distinctive and critical account of the current ethical, social and jurisprudential issues concerning stem cell science: together covering both its research beginnings, and the future translation into the clinical setting. Original to this volume is an emphasis on the inter-state implications of developments in stem cell science from the perspective of a truly global collaboration of leading authors. Academics and policy-makers will find it an invaluable contribution to the socio-political and ethical discourse of stem cell science. Contributions from a team of leading academic experts Covers a wide array of disciplines: with original contributions focusing on the technological, legal, social and ethical aspects of stem cell science A unique collection of international perspectives on developments in stem cell science Book jacket.