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An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.
This open access book explores ways to leverage information technology and machine learning to combat disease and promote health, especially in resource-constrained settings. It focuses on digital disease surveillance through the application of machine learning to non-traditional data sources. Developing countries are uniquely prone to large-scale emerging infectious disease outbreaks due to disruption of ecosystems, civil unrest, and poor healthcare infrastructure – and without comprehensive surveillance, delays in outbreak identification, resource deployment, and case management can be catastrophic. In combination with context-informed analytics, students will learn how non-traditional digital disease data sources – including news media, social media, Google Trends, and Google Street View – can fill critical knowledge gaps and help inform on-the-ground decision-making when formal surveillance systems are insufficient.
Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.
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.
This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.
It is well documented that slow patient enrollment is a global contributor of studydelays. Likewise, retaining patients once enrolled can be equally arduous, but just ascritical to the completion and success of a clinical trial. In her second book on thesubject, industry expert Diana Anderson-Foster tackles for the first time the globalchallenges posed by these everyday issues and provides thoughtful analysis and strategicsolutions to minimize recruitment costs and develop successful global patient recruitmentprograms. With insight and contributions from thought-leaders in the industry, this guidealso delves into the sponsor's perspective on patient recruitment and tackles new emergingtopics including technology challenges, phase I recruiting and the role of social media. This guide is a valuable and indispensable resource for anyone involved in clinicaloperations, specifically patient recruitment and retention.
Accompanying CD-Rom has same title as book.
Based on a 2003 workshop, this study describes current public and private programs and recommends ways to recruit and retain more women and underrepresented minorities into clinical research, especially physician-scientists and nurses. Federal sponsors should improve data collection, evaluate existing training programs, and increase the diversity of study section review panels. Public and private sponsors should create funding mechanisms with flexible career paths, and universities and professional societies should both play enhanced roles in fostering diversity. A significant push is needed to recruit minorities into nursing and provide more clinical research training for nurse-scientists, nursing students, and nursing faculty.
This thought-provoking collection examines the challenge of teacher shortages that is of international concern. It presents multiple perspectives, and explores the commonalities and differences in approaches from around the world to understand possible solutions for the current teacher workforce crisis. Acknowledging that solutions to attract and retain teachers vary by country, region and in some cases locality, the contributors scrutinise a range of workforce planning interventions at local and government level, including financial incentives and early career support. The book draws on different perspectives to understand a range of problems that negatively affect teacher recruitment and retention, unpicking key challenges, including links between the disadvantages of location and access to teachers for coastal and rural schools, rising pupil numbers, declining school budgets and the role of professional learning in raising teacher status. Abundant in critiques, research-informed positions and context-specific discussions about the impact of teacher workforce supply and shortages, this book will be valuable reading for teacher educators, educational leaders, education policy makers and academics in the field.