Control And The Therapeutic Trial

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Small Clinical Trials

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309171148
Total Pages : 221 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Small Clinical Trials by : Institute of Medicine

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

The Prevention and Treatment of Missing Data in Clinical Trials

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 030918651X
Total Pages : 163 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Prevention and Treatment of Missing Data in Clinical Trials by : National Research Council

Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Smart Health Choices

Author : Les Irwig
Publisher : Judy Irwig
ISBN 13 : 1905140177
Total Pages : 255 pages
Book Rating : 4.9/5 (51 download)

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Book Synopsis Smart Health Choices by : Les Irwig

Download or read book Smart Health Choices written by Les Irwig and published by Judy Irwig. This book was released on 2008 with total page 255 pages. Available in PDF, EPUB and Kindle. Book excerpt: Every day we make decisions about our health - some big and some small. What we eat, how we live and even where we live can affect our health. But how can we be sure that the advice we are given about these important matters is right for us? This book will provide you with the right tools for assessing health advice.

Validity and Inter-Rater Reliability Testing of Quality Assessment Instruments

Author : U. S. Department of Health and Human Services
Publisher : CreateSpace
ISBN 13 : 9781484077146
Total Pages : 108 pages
Book Rating : 4.0/5 (771 download)

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Book Synopsis Validity and Inter-Rater Reliability Testing of Quality Assessment Instruments by : U. S. Department of Health and Human Services

Download or read book Validity and Inter-Rater Reliability Testing of Quality Assessment Instruments written by U. S. Department of Health and Human Services and published by CreateSpace. This book was released on 2013-04-09 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: The internal validity of a study reflects the extent to which the design and conduct of the study have prevented bias(es). One of the key steps in a systematic review is assessment of a study's internal validity, or potential for bias. This assessment serves to: (1) identify the strengths and limitations of the included studies; (2) investigate, and potentially explain heterogeneity in findings across different studies included in a systematic review; and (3) grade the strength of evidence for a given question. The risk of bias assessment directly informs one of four key domains considered when assessing the strength of evidence. With the increase in the number of published systematic reviews and development of systematic review methodology over the past 15 years, close attention has been paid to the methods for assessing internal validity. Until recently this has been referred to as “quality assessment” or “assessment of methodological quality.” In this context “quality” refers to “the confidence that the trial design, conduct, and analysis has minimized or avoided biases in its treatment comparisons.” To facilitate the assessment of methodological quality, a plethora of tools has emerged. Some of these tools were developed for specific study designs (e.g., randomized controlled trials (RCTs), cohort studies, case-control studies), while others were intended to be applied to a range of designs. The tools often incorporate characteristics that may be associated with bias; however, many tools also contain elements related to reporting (e.g., was the study population described) and design (e.g., was a sample size calculation performed) that are not related to bias. The Cochrane Collaboration recently developed a tool to assess the potential risk of bias in RCTs. The Risk of Bias (ROB) tool was developed to address some of the shortcomings of existing quality assessment instruments, including over-reliance on reporting rather than methods. Several systematic reviews have catalogued and critiqued the numerous tools available to assess methodological quality, or risk of bias of primary studies. In summary, few existing tools have undergone extensive inter-rater reliability or validity testing. Moreover, the focus of much of the tool development or testing that has been done has been on criterion or face validity. Therefore it is unknown whether, or to what extent, the summary assessments based on these tools differentiate between studies with biased and unbiased results (i.e., studies that may over- or underestimate treatment effects). There is a clear need for inter-rater reliability testing of different tools in order to enhance consistency in their application and interpretation across different systematic reviews. Further, validity testing is essential to ensure that the tools being used can identify studies with biased results. Finally, there is a need to determine inter-rater reliability and validity in order to support the uptake and use of individual tools that are recommended by the systematic review community, and specifically the ROB tool within the Evidence-based Practice Center (EPC) Program. In this project we focused on two tools that are commonly used in systematic reviews. The Cochrane ROB tool was designed for RCTs and is the instrument recommended by The Cochrane Collaboration for use in systematic reviews of RCTs. The Newcastle-Ottawa Scale is commonly used for nonrandomized studies, specifically cohort and case-control studies.

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

Author : Agency for Health Care Research and Quality (U.S.)
Publisher : Government Printing Office
ISBN 13 : 1587634236
Total Pages : 236 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide by : Agency for Health Care Research and Quality (U.S.)

Download or read book Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide written by Agency for Health Care Research and Quality (U.S.) and published by Government Printing Office. This book was released on 2013-02-21 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)

Control and the Therapeutic Trial

Author : Martin Edwards
Publisher : BRILL
ISBN 13 : 9401204942
Total Pages : 227 pages
Book Rating : 4.4/5 (12 download)

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Book Synopsis Control and the Therapeutic Trial by : Martin Edwards

Download or read book Control and the Therapeutic Trial written by Martin Edwards and published by BRILL. This book was released on 2015-07-14 with total page 227 pages. Available in PDF, EPUB and Kindle. Book excerpt: Listen to podcast with the author How do doctors decide whether their drugs, or other treatments, actually work? In practice this can be fiendishly difficult. Nowadays the gold standard is the randomised controlled trial (RCT). But the RCT is a recent invention, and the story of how it came to dominate therapeutic evaluation from the latter half of the twentieth century involves acrimony, confrontation, and manipulation of the powerful rhetoric of ‘control’. Control and the Therapeutic Trial examines the development of the RCT from the eclectic collection of methodologies available to practitioners in the early-twentieth century. In particular, it explores the British Medical Research Council’s (MRC) exploitation of the term ‘controlled’ to help establish its own ‘controlled trials’ as the gold standard for therapeutic evaluation, and, ultimately, the MRC itself as the proper authority to adjudicate on therapeutic efficacy. This rhetorical power still clings, and is exploited today. Control and the Therapeutic Trial will be of interest not only to historians of twentieth-century medicine and practising clinicians who take therapeutic decisions, but to anyone who seeks a broader insight into the forces that shaped, and control, the modern controlled trial.

Field Trials of Health Interventions

Author : Peter G. Smith
Publisher :
ISBN 13 : 0198732864
Total Pages : 479 pages
Book Rating : 4.1/5 (987 download)

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Book Synopsis Field Trials of Health Interventions by : Peter G. Smith

Download or read book Field Trials of Health Interventions written by Peter G. Smith and published by . This book was released on 2015 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.

Sharing Clinical Trial Data

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Complex Interventions in Health

Author : David A. Richards
Publisher : Routledge
ISBN 13 : 1134470568
Total Pages : 444 pages
Book Rating : 4.1/5 (344 download)

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Book Synopsis Complex Interventions in Health by : David A. Richards

Download or read book Complex Interventions in Health written by David A. Richards and published by Routledge. This book was released on 2015-04-17 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health and human services currently face a series of challenges – such as aging populations, chronic diseases and new endemics – that require highly complex responses, and take place in multiple care environments including acute medicine, chronic care facilities and the community. Accordingly, most modern health care interventions are now seen as ‘complex interventions’ – activities that contain a number of component parts with the potential for interactions between them which, when applied to the intended target population, produce a range of possible and variable outcomes. This in turn requires methodological developments that also take into account changing values and attitudes related to the situation of patients’ receiving health care. The first book to place complex interventions within a coherent system of research enquiry, this work is designed to help researchers understand the research processes involved at each stage of developing, testing, evaluating and implementing complex interventions, and assist them to integrate methodological activities to produce secure, evidence-based health care interventions. It begins with conceptual chapters which set out the complex interventions framework, discuss the interrelation between knowledge development and evidence, and explore how mixed methods research contributes to improved health. Structured around the influential UK Medical Research Council guidance for use of complex interventions, four sections, each comprised of bite-sized chapters written by multidisciplinary experts in the area, focus on: - Developing complex interventions - Assessing the feasibility of complex interventions and piloting them - Evaluating complex interventions - Implementing complex interventions. Accessible to students and researchers grappling with complex interventions, each substantive chapter includes an introduction, bulleted learning objectives, clinical examples, a summary and further reading. The perspectives of various stakeholders, including patients, families and professionals, are discussed throughout as are the economic and ethical implications of methods. A vital companion for health research, this book is suitable for readers from multidisciplinary disciplines such as medical, nursing, public health, health services research, human services and allied healthcare backgrounds.

Saving Women's Lives

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309165946
Total Pages : 384 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Saving Women's Lives by : National Research Council

Download or read book Saving Women's Lives written by National Research Council and published by National Academies Press. This book was released on 2005-03-18 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: The outlook for women with breast cancer has improved in recent years. Due to the combination of improved treatments and the benefits of mammography screening, breast cancer mortality has decreased steadily since 1989. Yet breast cancer remains a major problem, second only to lung cancer as a leading cause of death from cancer for women. To date, no means to prevent breast cancer has been discovered and experience has shown that treatments are most effective when a cancer is detected early, before it has spread to other tissues. These two facts suggest that the most effective way to continue reducing the death toll from breast cancer is improved early detection and diagnosis. Building on the 2001 report Mammography and Beyond, this new book not only examines ways to improve implementation and use of new and current breast cancer detection technologies but also evaluates the need to develop tools that identify women who would benefit most from early detection screening. Saving Women's Lives: Strategies for Improving Breast Cancer Detection and Diagnosis encourages more research that integrates the development, validation, and analysis of the types of technologies in clinical practice that promote improved risk identification techniques. In this way, methods and technologies that improve detection and diagnosis can be more effectively developed and implemented.

Evidence-Based Management of Low Back Pain - E-Book

Author : Simon Dagenais
Publisher : Elsevier Health Sciences
ISBN 13 : 0323079245
Total Pages : 497 pages
Book Rating : 4.3/5 (23 download)

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Book Synopsis Evidence-Based Management of Low Back Pain - E-Book by : Simon Dagenais

Download or read book Evidence-Based Management of Low Back Pain - E-Book written by Simon Dagenais and published by Elsevier Health Sciences. This book was released on 2011-01-31 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering all commonly used interventions for acute and chronic low back pain conditions, Evidence-Based Management of Low Back Pain consolidates current scientific studies and research evidence into a single, practical resource. Its multidisciplinary approach covers a wide scope of treatments from manual therapies to medical interventions to surgery, organizing interventions from least to most invasive. Editors Simon Dagenais and Scott Haldeman, along with expert contributors from a variety of clinical and academic institutions throughout the world, focus on the best available scientific evidence, summarizing the results from the strongest to the weakest types of studies. No other book makes it so easy to compare the different interventions and treatment approaches, giving you the tools to make better, more informed clinical decisions. - A multidisciplinary approach covers treatments from manual therapies to medical interventions to surgery, and many others in between. - An interdisciplinary approach enables health care providers to work together. - A logical, easy-to-follow organization covers information by intervention type, from least invasive to most invasive. - Integration of interventions provides information in a clinically useful way, so it's easier to consider more than one type of treatment or intervention for low back pain, and easier to see which methods should be tried first. - 155 illustrations include x-rays, photos, and drawings. - Tables and boxes summarize key information. - Evidence-based content allows you to make clinical decisions based on the ranking the best available scientific studies from strongest to weakest. - Patient history and examination chapters help in assessing the patient's condition and in ruling out serious pathology before making decisions about specific interventions. - Experienced editors and contributors are proven authors, researchers, and teachers, and practitioners, well known in the areas of orthopedics, pain management, chiropractic, physical therapy, and behavioral medicine as well as complementary and alternative medicine; the book's contributors include some of the leading clinical and research experts in the field of low back pain. - Coverage based on The Spine Journal special issue on low back pain ensures that topics are relevant and up to date. - A systematic review of interventions for low back pain includes these categories: patient education, exercise and rehabilitation, medications, manual therapy, physical modalities, complementary and alternative medicine, behavioral modification, injections, minimally invasive procedures, and surgery. - Surgical interventions include decompression, fusion, disc arthroplasty, and dynamic stabilization. - Additional coverage includes patient education and multidisciplinary rehabilitation.

Acute Ischemic Stroke

Author : R. Gilberto González
Publisher : Springer Science & Business Media
ISBN 13 : 3642127517
Total Pages : 299 pages
Book Rating : 4.6/5 (421 download)

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Book Synopsis Acute Ischemic Stroke by : R. Gilberto González

Download or read book Acute Ischemic Stroke written by R. Gilberto González and published by Springer Science & Business Media. This book was released on 2010-10-05 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: This updated second edition of Acute Ischemic Stroke: Imaging and Intervention provides a comprehensive account of the state of the art in the diagnosis and treatment of acute ischemic stroke. The basic format of the first edition has been retained, with sections on fundamentals such as pathophysiology and causes, imaging techniques and interventions. However, each chapter has been revised to reflect the important recent progress in advanced neuroimaging and the use of interventional tools. In addition, a new chapter is included on the classification instruments for ischemic stroke and their use in predicting outcomes and therapeutic triage. All of the authors are internationally recognized experts and members of the interdisciplinary stroke team at the Massachusetts General Hospital and Harvard Medical School. The text is supported by numerous informative illustrations, and ease of reference is ensured through the inclusion of suitable tables. This book will serve as a unique source of up-to-date information for neurologists, emergency physicians, radiologists and other health care providers who care for the patient with acute ischemic stroke.

Clinical Trials

Author : Tom Brody
Publisher : Academic Press
ISBN 13 : 0128042583
Total Pages : 897 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Clinical Trials by : Tom Brody

Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2016-02-19 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. - Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more - Extensively covers the "study schema" and related features of study design - Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials - Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers

Drugs on Trial

Author : Andreas-Holger Maehle
Publisher : Rodopi
ISBN 13 : 9789042007932
Total Pages : 388 pages
Book Rating : 4.0/5 (79 download)

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Book Synopsis Drugs on Trial by : Andreas-Holger Maehle

Download or read book Drugs on Trial written by Andreas-Holger Maehle and published by Rodopi. This book was released on 1999 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the main issues of eighteenth-century pharmacology and therapeutics and provides detailed case studies of three key areas: lithontriptics (remedies against urinary stones), opium, and Peruvian bark (quinine).

The Oxford Handbook of Research Strategies for Clinical Psychology

Author : Jonathan S. Comer
Publisher : Oxford University Press
ISBN 13 : 0199793549
Total Pages : 476 pages
Book Rating : 4.1/5 (997 download)

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Book Synopsis The Oxford Handbook of Research Strategies for Clinical Psychology by : Jonathan S. Comer

Download or read book The Oxford Handbook of Research Strategies for Clinical Psychology written by Jonathan S. Comer and published by Oxford University Press. This book was released on 2013-05-09 with total page 476 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Oxford Handbook of Research Strategies for Clinical Psychology has recruited some of the field's foremost experts to explicate the essential research strategies currently used across the modern clinical psychology landscape that maximize both scientific rigor and clinical relevance.

Fundamentals of Clinical Trials

Author : Lawrence M. Friedman
Publisher : Springer Science & Business Media
ISBN 13 : 9780387985862
Total Pages : 384 pages
Book Rating : 4.9/5 (858 download)

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Book Synopsis Fundamentals of Clinical Trials by : Lawrence M. Friedman

Download or read book Fundamentals of Clinical Trials written by Lawrence M. Friedman and published by Springer Science & Business Media. This book was released on 1998 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Transforming Clinical Research in the United States

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309163358
Total Pages : 151 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Transforming Clinical Research in the United States by : Institute of Medicine

Download or read book Transforming Clinical Research in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-22 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.