Emerging Safety Science

In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved. DiMasi and Grabowski report that only 21.5 percent of the candidate drugs that enter phase I clinical testing actually make it to market. In 2007, just 17 novel drugs and 2 novel biologics were approved. In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006). Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients. Emerging scientific knowledge and technologies hold the potential to enhance correct decision making for the advancement of candidate drugs. Identification of safety problems is a key reason that new drug development is stalled. Traditional methods for assessing a drug's safety prior to approval are limited in their ability to detect rare safety problems. Prior to receiving U.S. Food and Drug Administration (FDA) approval, a drug will have been tested in hundreds to thousands of patients. Generally, drugs cannot confidently be linked to safety problems until they have been tested in tens of thousands to hundreds of thousands of people. With current methods, it is unlikely that rare safety problems will be identified prior to approval. Emerging Safety Science: Workshop Summary summarizes the events and presentations of the workshop.

Safety Science Research: Evolution, Challenges and New Directions provides a unique perspective into the latest developments of safety science by putting together, for the first time, a new generation of authors with some of the pioneers of the field. Forty years ago, research traditions were developed, including, among others, high-reliability organisations, cognitive system engineering or safety regulations. In a fast-changing world, the new generation introduces, in this book, new disciplinary insights, addresses contemporary empirical issues, develops new concepts and models while remaining critical of safety research practical ambitions. Their ideas are then reflected and discussed by some of the pioneers of safety science. Features Allows the reader to discover how contemporary safety issues are currently framed by a new generation of researchers, brought together for the first time Includes an introduction and guide to the development of safety science over the last four decades Features an extraordinary collection of expert contributors, including pioneers of safety research, reflecting the evolution of the discipline and offering insightful commentary on the current and future state of the field Serves as an invaluable reference and guide for safety professionals and students from any established disciplines such as sociology, engineering, psychology, political science or management as well as dedicated safety programmes Some figures in the eBook are in colour

For many years "safety technology" has constituted the essential instrument for the prevention of accidents as a direct result of handling new technology. Its awareness of the interactions prevalent in natural science causes safety technology to act on the basis of actual accidents, and it Ulilizes to their fullest extent any means provided by the engineering sciences. Man proceeds in a general direction towards preselVation and improvement, thus working towards the optimization of the technical design. However. a new set of basic problems presented itself the moment new large-scale technologies were introduced into the areas of processing, energy, and traffic, thereby creating a considerable amount of ad ditional danger potential. This also signified the end of an era when safety technology could be practiced chiefly on the basis of accident statistics. For ethical reasons it became necessary that a credible prognosis as to the type and effect of accidents took the place, or at least supplemented, the hitherto practiced purely reactive methods. The realization that the available means of safety technology were no longer sufficient in a highly technologized environment spurred the demand for entirely new concepts which would eventually lead to a higher degree of safety. A decisive step had to be taken away from a purely technical approach and fOwards and all-encompassing look at accident systems, because man had become aware of the fact that accidents will always be a part of the interaction between man, technology, and environment.

Food Safety: Emerging Issues, Technologies and Systems offers a systems approach to learning how to understand and address some of the major complex issues that have emerged in the food industry. The book is broad in coverage and provides a foundation for a practical understanding in food safety initiatives and safety rules, how to deal with whole-chain traceability issues, handling complex computer systems and data, foodborne pathogen detection, production and processing compliance issues, safety education, and more. Recent scientific industry developments are written by experts in the field and explained in a manner to improve awareness, education and communication of these issues. Examines effective control measures and molecular techniques for understanding specific pathogens Presents GFSI implementation concepts and issues to aid in implementation Demonstrates how operation processes can achieve a specific level of microbial reduction in food Offers tools for validating microbial data collected during processing to reduce or eliminate microorganisms in foods

The harm associated with health care is a questionable issue and several systemic global strategies to reduce it with a safer system are being developed. Despite these efforts, errors continue to happen and one of the most important challenges is to become aware of its real dimension and process-occurrence. This book provides new research on patient safety and management. It discusses different perspectives, principles and reviews emerging issues in the medical field.

How do accidents and disasters occur? How has knowledge of accident processes evolved? A significant improvement in safety has occurred during the past century, with the number of accidents falling spectacularly within industry, aviation and road traffic. This progress has been gradual in the context of a changing society. The improvements are partly due to a better understanding of the accident processes that ultimately lead to damage. This book shows how contemporary crises instigated the development of safety knowledge and how the safety sciences pieced their theories together by research, by experience and by taking ideas from other domains. From Safety to Safety Science details 150 years of knowledge development in the safety sciences. The authors have rigorously extracted the essence of safety knowledge development from more than 2,500 articles to provide a unique overview and insight into the background and usability of safety theories, as well as modelling how they developed and how they are used today. Extensive appendices and references provide an additional dimension to support further scholarly work in this field. The book is divided into clear time periods to make it an accessible piece of science history that will be invaluable to both new and experienced safety researchers, to safety courses and education, and to learned practitioners.

Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.

For many years "safety technology" has constituted the essential instrument for the prevention of accidents as a direct result of handling new technology. Its awareness of the interactions prevalent in natural science causes safety technology to act on the basis of actual accidents, and it Ulilizes to their fullest extent any means provided by the engineering sciences. Man proceeds in a general direction towards preselVation and improvement, thus working towards the optimization of the technical design. However. a new set of basic problems presented itself the moment new large-scale technologies were introduced into the areas of processing, energy, and traffic, thereby creating a considerable amount of ad ditional danger potential. This also signified the end of an era when safety technology could be practiced chiefly on the basis of accident statistics. For ethical reasons it became necessary that a credible prognosis as to the type and effect of accidents took the place, or at least supplemented, the hitherto practiced purely reactive methods. The realization that the available means of safety technology were no longer sufficient in a highly technologized environment spurred the demand for entirely new concepts which would eventually lead to a higher degree of safety. A decisive step had to be taken away from a purely technical approach and fOwards and all-encompassing look at accident systems, because man had become aware of the fact that accidents will always be a part of the interaction between man, technology, and environment.