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Transforming Clinical Research in the United States - Challenges and Opportunities: Workshop Summary (Paperback)
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Transforming Clinical Research in the United States - Challenges and Opportunities: Workshop Summary (Paperback)
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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. Table of Contents
Front Matter 1 Introduction 2 The State of Clinical Research in the
United States: An Overview 3 Challenges in Clinical Research 4
Clinical Trials in Cardiovascular Disease 5 Clinical Trials in
Depression 6 Clinical Trials in Cancer 7 Clinical Trials in
Diabetes 8 Building a Robust Clinical Trials Infrastructure
References Appendix A Agenda Appendix B Participant Biographies
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