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Book
Addressing the threat of drug-resistant tuberculosis : a realistic assessment of the challenge : workshop summary
Authors: --- ---
ISBN: 0309130441 9786612454844 1282454846 030913045X 9780309130455 9780309130448 030914874X Year: 2009 Publisher: Washington, D.C. : National Academies Press,

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"Tuberculosis is one of the leading causes of death in the world today, with 4,500 people dying from the disease every day. Many cases of TB can be cured by available antibiotics, but some TB is resistant to multiple drugs--a major and growing threat worldwide. The Institute of Medicine's Forum on Drug Discovery, Development, and Translation hosted a workshop on November 5, 2008, to address the mounting concern of drug-resistant TB. The session brought together a wide range of international experts to discuss what is known and not known about this growing threat, and to explore possible solutions."--Publisher's website.

Emerging safety science : workshop summary
Authors: --- --- ---
ISBN: 0309110122 9786611300234 1281300233 0309110130 0309178177 Year: 2008 Publisher: Washington, D.C. : National Academies Press,


Book
Breakthrough business models : drug development for rare and neglected diseases and individualized therapies : workshop summary
Authors: --- --- ---
ISBN: 0309120888 9786612083556 0309120896 1282083554 0309178169 Year: 2009 Publisher: Washington, D.C. : National Academies Press,

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"The Institute of Medicine's Forum on Drug Discovery, Development, and Translation held a public workshop on June 23, 2008, titled "Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies." The purpose of the workshop was to explore innovative strategies for orphan drug development."--P. 3.


Book
Transforming clinical research in the United States : challenges and opportunities : workshop summary
Authors: --- --- --- ---
ISBN: 0309153328 9786612917028 0309153336 1282917021 0309163358 Year: 2010 Publisher: Washington, D.C. : National Academies Press,

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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."--Publisher's description.


Book
Accelerating the development of biomarkers for drug safety : workshop summary
Authors: --- --- --- ---
ISBN: 0309131243 0309131251 9786612272653 1282272659 0309142318 Year: 2009 Publisher: Washington, D.C. : National Academies Press,

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"Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held 'Assessing and Accelerating Development of Biomarkers for Drug Safety,' a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development."--Publisher's website.

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