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.

Translational Research in Coronary Artery Disease: Pathophysiology to Treatment covers the entire spectrum of basic science, genetics, drug treatment, and interventions for coronary artery disease. With an emphasis on vascular biology, this reference fully explains the fundamental aspects of coronary artery disease pathophysiology. Included are important topics, including endothelial function, endothelial injury, and endothelial repair in various disease states, vascular smooth muscle function and its interaction with the endothelium, and the interrelationship between inflammatory biology and vascular function. By providing this synthesis of current research literature, this reference allows the cardiovascular scientist and practitioner to access everything they need from one source. - Provides a concise summary of recent developments in coronary and vascular research, including previously unpublished data - Summarizes in-depth discussions of the pathobiology and novel treatment strategies for coronary artery disease - Provides access to an accompanying website that contains photos and videos of noninvasive diagnostic modalities for evaluation of coronary artery disease

The Social Security Administration (SSA) uses a screening tool called the Listing of Impairments to identify claimants who are so severely impaired that they cannot work at all and thus immediately qualify for benefits. In this report, the IOM makes several recommendations for improving SSA's capacity to determine disability benefits more quickly and efficiently using the Listings.

This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.

The definitive reference work on clinical trials, this book presents a wealth of detailed, practical information on the design, conduct, and analysis of both single center and multicenter trials. No other book on clinical trials offers as much detail as Meinert does on such issues as sample size calculation, stratification and randomization, data systems design, consent form development, publication policies, preparation of funding requests, and reporting procedures.