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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...
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.
Careers in Clinical Research
Transforming biological discoveries into medical treatment calls for a cadre of health professionals skilled in patient-oriented research. Yet many factors discourage talented persons from choosing clinical research as a profession. This new volume lays out the problem in detail, with specific recommendations to the federal government, the biotechnology and pharmaceutical industries, professional organizations, the health care industry, organized medicine, and the nation's universities and academic health centers. The volume explores How clinical research is conducted, what human resources are available, and what research opportunities lie ahead. Why health professionals become discouraged about clinical research. How the educational system has failed in this area and what programs stand out as models. How funding affects the supply of researchers. This practical book will be of immediate interest to public and private agencies funding research, research administrators, medical educators, health professionals, and those pursuing a career in clinical investigation.
Understanding Clinical Research
A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinica...
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.
Clinical and Translational Science
Clinical or translational science is the field of study devoted to investigating human health and disease, interventions and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. New molecular tools and diagnostic technologies based on clinical and translational research have lead to a better understanding of human disease and the application of new therapeutics for enhanced health. Clinical and Translational Science is designed as the most authoritative and modern resource for the broad range of investigators in various medical specialties taking on the challenge of clinical research. Prepared with an international perspective, this res...
Envisioning a Transformed Clinical Trials Enterprise in the United States
There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.
Encyclopedia of Health Services Research
Today, as never before, healthcare has the ability to enhance the quality and duration of life. At the same time, healthcare has become so costly that it can easily bankrupt governments and impoverish individuals and families. Health services research is a highly multidisciplinary field, including such areas as health administration, health economics, medical sociology, medicine, , political science, public health, and public policy. The Encyclopedia of Health Services Research is the first single reference source to capture the diversity and complexity of the field. With more than 400 entries, these two volumes investigate the relationship between the factors of cost, quality, and access to...
