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Exploring Challenges, Progress, and New Models for Engaging the Public in the Clinical Research Enterprise
This report is a summary of a workshop focused on exploring the role of the public in the Clinical Research Enterprise. The Clinical Research Enterprise depends upon practitioners, policy makers, and others for participation in trials, ethical review of research, and continued support of research funding. However, the role of the public has expanded beyond this traditional model as consumers have begun to demand a role in the formulation of the research agenda and in the design, review, and pursuit of research. This report identifies four major challenges to the Clinical Research Enterprise: enhancing public participation in clinical research, which includes making the system safer and faste...
The Role of Purchasers and Payers in the Clinical Research Enterprise
In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.
Summary of the June 2000 Meeting of the Clinical Research Roundtable
The 28-member Clinical Research Roundtable (CRR) consists of individuals from a broad range of government, commercial, academic, and non-profit institutions that will gather quarterly for the next 3 years to discuss the challenges facing clinical research. Its June 27-28 meeting was partly organizational in nature, as the members discussed their interests and priorities for future work. The centerpiece of the meeting was a mini-symposium in which several invited speakers helped the CRR explore some of the difficulties involved in attracting, training, and sustaining clinical investigators. The group concluded by forming four groups to explore potential activities in the areas of data collection, the current and evolving clinical research process, career development, and public involvement in clinical research.
Rational Therapeutics for Infants and Children
The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicin...
The Learning Healthcare System
As our nation enters a new era of medical science that offers the real prospect of personalized health care, we will be confronted by an increasingly complex array of health care options and decisions. The Learning Healthcare System considers how health care is structured to develop and to apply evidence-from health profession training and infrastructure development to advances in research methodology, patient engagement, payment schemes, and measurement-and highlights opportunities for the creation of a sustainable learning health care system that gets the right care to people when they need it and then captures the results for improvement. This book will be of primary interest to hospital ...
Sharing Clinical Research Data
Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organi...
Stroke Recovery and Rehabilitation
A Doody's Core Title 2012 Stroke Recovery and Rehabilitation is the new gold standard comprehensive guide to the management of stroke patients. Beginning with detailed information on risk factors, epidemiology, prevention, and neurophysiology, the book details the acute and long-term treatment of all stroke-related impairments and complications. Additional sections discuss psychological issues, outcomes, community reintegration, and new research. Written by dozens of acknowledged leaders in the field, and containing hundreds of tables, graphs, and photographic images, Stroke Recovery and Rehabilitation features: The first full-length discussion of the most commonly-encountered component of n...
Principles and Practice of Clinical Research
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research...
The Healthcare Imperative
The United States has the highest per capita spending on health care of any industrialized nation but continually lags behind other nations in health care outcomes including life expectancy and infant mortality. National health expenditures are projected to exceed $2.5 trillion in 2009. Given healthcare's direct impact on the economy, there is a critical need to control health care spending. According to The Health Imperative: Lowering Costs and Improving Outcomes, the costs of health care have strained the federal budget, and negatively affected state governments, the private sector and individuals. Healthcare expenditures have restricted the ability of state and local governments to fund o...
Guidelines for the Humane Transportation of Research Animals
Arranging the transportation of animals at research facilities is often an ordeal. There is a confusing patchwork of local, national, and international regulations; a perceived lack of high-quality shipping services; a dearth of science-based good practices; and a lack of biosafety standards. It's a challenge â€"and an impediment to biomedical research. Guidelines for the Humane Transportation of Research Animals identifies the current problems encountered in the transportation of research animals and offers recommendations aimed at local and federal officials to rectify these problems. This book also includes a set of good practices based on the extensive body of literature on transporta...
