Sharing Clinical Trial Data

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Author :
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.

Using Test Data in Clinical Practice

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Author :
Publisher : SAGE
ISBN 13 : 9780761921882
Total Pages : 290 pages
Book Rating : 4.9/5 (218 download)

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Book Synopsis Using Test Data in Clinical Practice by : Kathryn C MacCluskie

Download or read book Using Test Data in Clinical Practice written by Kathryn C MacCluskie and published by SAGE. This book was released on 2002 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Material presented in many testing textbooks is appropriately broad and comprehensive, but the effect for students new to testing is difficulty in then translating the extensive information into the practical skills of administering, scoring, and interpreting tests to help inform the treatment process. Few resources exist to help students and mental health clinicians with the daunting task of learning how to synthesize test data from numerous instruments into a meaningful treatment plan and strategy for a client. This book was written to address that need. It provides readers with clear and detailed step-by-step procedures for using the WAIS-III, MMPI 2, MMPI A, Kuder Occupational Interest Survey, and the Strong Interest Inventory. It features case examples and practice opportunities in test usage, detailed discussion of approaches to client feedback and report writing, and a review of ethical and legal considerations in using tests in clinical settings. It takes readers through a systematic explanation of how to understand and integrate data from multiple sources to maximize the information gleaned from the tests. It also emphasizes using test data to maximize helpfulness to the client and how to interpret test data to clients in language that is understandable.

Registries for Evaluating Patient Outcomes

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Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. 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.

The Prevention and Treatment of Missing Data in Clinical Trials

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Author :
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.

Improving Diagnosis in Health Care

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Publisher : National Academies Press
ISBN 13 : 0309377722
Total Pages : 473 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Improving Diagnosis in Health Care by : National Academies of Sciences, Engineering, and Medicine

Download or read book Improving Diagnosis in Health Care written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2015-12-29 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: Getting the right diagnosis is a key aspect of health care - it provides an explanation of a patient's health problem and informs subsequent health care decisions. The diagnostic process is a complex, collaborative activity that involves clinical reasoning and information gathering to determine a patient's health problem. According to Improving Diagnosis in Health Care, diagnostic errors-inaccurate or delayed diagnoses-persist throughout all settings of care and continue to harm an unacceptable number of patients. It is likely that most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences. Diagnostic errors may cause harm to patients by preventing or delaying appropriate treatment, providing unnecessary or harmful treatment, or resulting in psychological or financial repercussions. The committee concluded that improving the diagnostic process is not only possible, but also represents a moral, professional, and public health imperative. Improving Diagnosis in Health Care, a continuation of the landmark Institute of Medicine reports To Err Is Human (2000) and Crossing the Quality Chasm (2001), finds that diagnosis-and, in particular, the occurrence of diagnostic errorsâ€"has been largely unappreciated in efforts to improve the quality and safety of health care. Without a dedicated focus on improving diagnosis, diagnostic errors will likely worsen as the delivery of health care and the diagnostic process continue to increase in complexity. Just as the diagnostic process is a collaborative activity, improving diagnosis will require collaboration and a widespread commitment to change among health care professionals, health care organizations, patients and their families, researchers, and policy makers. The recommendations of Improving Diagnosis in Health Care contribute to the growing momentum for change in this crucial area of health care quality and safety.

Fundamentals of Clinical Data Science

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Publisher : Springer
ISBN 13 : 3319997130
Total Pages : 219 pages
Book Rating : 4.3/5 (199 download)

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Book Synopsis Fundamentals of Clinical Data Science by : Pieter Kubben

Download or read book Fundamentals of Clinical Data Science written by Pieter Kubben and published by Springer. This book was released on 2018-12-21 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.

Beyond the HIPAA Privacy Rule

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Publisher : National Academies Press
ISBN 13 : 0309124999
Total Pages : 334 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine

Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Psychological Testing in the Service of Disability Determination

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Publisher : National Academies Press
ISBN 13 : 0309370930
Total Pages : 233 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Psychological Testing in the Service of Disability Determination by : Institute of Medicine

Download or read book Psychological Testing in the Service of Disability Determination written by Institute of Medicine and published by National Academies Press. This book was released on 2015-06-29 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: The United States Social Security Administration (SSA) administers two disability programs: Social Security Disability Insurance (SSDI), for disabled individuals, and their dependent family members, who have worked and contributed to the Social Security trust funds, and Supplemental Security Income (SSSI), which is a means-tested program based on income and financial assets for adults aged 65 years or older and disabled adults and children. Both programs require that claimants have a disability and meet specific medical criteria in order to qualify for benefits. SSA establishes the presence of a medically-determined impairment in individuals with mental disorders other than intellectual disability through the use of standard diagnostic criteria, which include symptoms and signs. These impairments are established largely on reports of signs and symptoms of impairment and functional limitation. Psychological Testing in the Service of Disability Determination considers the use of psychological tests in evaluating disability claims submitted to the SSA. This report critically reviews selected psychological tests, including symptom validity tests, that could contribute to SSA disability determinations. The report discusses the possible uses of such tests and their contribution to disability determinations. Psychological Testing in the Service of Disability Determination discusses testing norms, qualifications for administration of tests, administration of tests, and reporting results. The recommendations of this report will help SSA improve the consistency and accuracy of disability determination in certain cases.

Assessment of Diagnostic Technology in Health Care

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Publisher : National Academies Press
ISBN 13 : 030904099X
Total Pages : 152 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Assessment of Diagnostic Technology in Health Care by : Institute of Medicine

Download or read book Assessment of Diagnostic Technology in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 1989-02-01 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technology assessment can lead to the rapid application of essential diagnostic technologies and prevent the wide diffusion of marginally useful methods. In both of these ways, it can increase quality of care and decrease the cost of health care. This comprehensive monograph carefully explores methods of and barriers to diagnostic technology assessment and describes both the rationale and the guidelines for meaningful evaluation. While proposing a multi-institutional approach, it emphasizes some of the problems involved and defines a mechanism for improving the evaluation and use of medical technology and essential resources needed to enhance patient care.

Studying A Study and Testing a Test

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Publisher : Lippincott Williams & Wilkins
ISBN 13 : 0781774268
Total Pages : 353 pages
Book Rating : 4.7/5 (817 download)

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Book Synopsis Studying A Study and Testing a Test by : Richard K. Riegelman

Download or read book Studying A Study and Testing a Test written by Richard K. Riegelman and published by Lippincott Williams & Wilkins. This book was released on 2012-06-18 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rev. ed. of: Studying a study and testing a test / Richard K. Riegelman.

Molecular Pathology in Clinical Practice

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Publisher : Springer
ISBN 13 : 331919674X
Total Pages : 989 pages
Book Rating : 4.3/5 (191 download)

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Book Synopsis Molecular Pathology in Clinical Practice by : Debra G.B. Leonard

Download or read book Molecular Pathology in Clinical Practice written by Debra G.B. Leonard and published by Springer. This book was released on 2016-02-02 with total page 989 pages. Available in PDF, EPUB and Kindle. Book excerpt: This authoritative textbook offers in-depth coverage of all aspects of molecular pathology practice and embodies the current standard in molecular testing. Since the successful first edition, new sections have been added on pharmacogenetics and genomics, while other sections have been revised and updated to reflect the rapid advances in the field. The result is a superb reference that encompasses molecular biology basics, genetics, inherited cancers, solid tumors, neoplastic hematopathology, infectious diseases, identity testing, HLA typing, laboratory management, genomics and proteomics. Throughout the text, emphasis is placed on the molecular variations being detected, the clinical usefulness of the tests and important clinical and laboratory issues. The second edition of Molecular Pathology in Clinical Practice will be an invaluable source of information for all practicing molecular pathologists and will also be of utility for other pathologists, clinical colleagues and trainees.

Advances in Patient Safety

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Publisher :
ISBN 13 :
Total Pages : 526 pages
Book Rating : 4.7/5 (54 download)

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Book Synopsis Advances in Patient Safety by : Kerm Henriksen

Download or read book Advances in Patient Safety written by Kerm Henriksen and published by . This book was released on 2005 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

Principles and Practice of Clinical Trials

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Publisher : Springer Nature
ISBN 13 : 3319526367
Total Pages : 2573 pages
Book Rating : 4.3/5 (195 download)

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Book Synopsis Principles and Practice of Clinical Trials by : Steven Piantadosi

Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Rosen's Emergency Medicine - Concepts and Clinical Practice, 2-Volume Set,Expert Consult Premium Edition - Enhanced Online Features and Print,7

Download Rosen's Emergency Medicine - Concepts and Clinical Practice, 2-Volume Set,Expert Consult Premium Edition - Enhanced Online Features and Print,7 PDF Online Free

Author :
Publisher : Elsevier Health Sciences
ISBN 13 : 0323054722
Total Pages : 3163 pages
Book Rating : 4.3/5 (23 download)

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Book Synopsis Rosen's Emergency Medicine - Concepts and Clinical Practice, 2-Volume Set,Expert Consult Premium Edition - Enhanced Online Features and Print,7 by : James Adams

Download or read book Rosen's Emergency Medicine - Concepts and Clinical Practice, 2-Volume Set,Expert Consult Premium Edition - Enhanced Online Features and Print,7 written by James Adams and published by Elsevier Health Sciences. This book was released on 2010-01-01 with total page 3163 pages. Available in PDF, EPUB and Kindle. Book excerpt: This reference places the latest information at users' fingertips, and a more streamlined format makes it easy to find the exact information quickly and conveniently. Includes access to a companion Web site for additional resources.

Multimethod Clinical Assessment

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Publisher : Guilford Publications
ISBN 13 : 1462516149
Total Pages : 489 pages
Book Rating : 4.4/5 (625 download)

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Book Synopsis Multimethod Clinical Assessment by : Christopher J. Hopwood

Download or read book Multimethod Clinical Assessment written by Christopher J. Hopwood and published by Guilford Publications. This book was released on 2014-06-10 with total page 489 pages. Available in PDF, EPUB and Kindle. Book excerpt: From leading authorities, this book presents evidence-based strategies for using multimethod assessment to enhance clinical practice. The volume is organized around key assessment targets in the areas of personality, psychopathology, and clinical management (for example, treatment planning and progress monitoring). Each chapter presents multiple methods that are particularly useful for assessing the issue at hand, provides a framework for using these methods together, and reviews the empirical data supporting their integration. Illustrative case examples clarify the approaches described and show how incorporating assessment into treatment can strengthen the therapeutic relationship.

The Mental Health Desk Reference

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Publisher : John Wiley & Sons
ISBN 13 : 0471441627
Total Pages : 551 pages
Book Rating : 4.4/5 (714 download)

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Book Synopsis The Mental Health Desk Reference by : Elizabeth Reynolds Welfel

Download or read book The Mental Health Desk Reference written by Elizabeth Reynolds Welfel and published by John Wiley & Sons. This book was released on 2001-08-17 with total page 551 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical, easy-to-use, and comprehensive reference for mental health professionals The Mental Health Desk Reference is the ultimate guide to effective and responsible mental health practice. It provides authoritative, concise, and up-to-date information from more than seventy experts regarding diagnosis, treatment, and ethics of practice. Each entry summarizes key constructs and terminology associated with the topic, major findings from research, and specific recommendations on theory and practice. Important topics covered include: * Adjustment disorders and life stress * Diagnosis and treatment of adults * Diagnosis and treatment of children * Crisis intervention * Diverse populations * Group and family interventions * Practice management * Professional issues * Ethical and legal issues * Professional resources These detailed, readable entries-based on the most extensive and reliable research available-form a comprehensive, straightforward, and quick-reference resource applicable to practitioners across every field in mental health. The Mental Health Desk Reference is the single resource no mental health professional can afford to be without.

Sharing Clinical Research Data

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Author :
Publisher : National Academies Press
ISBN 13 : 0309268745
Total Pages : 157 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Sharing Clinical Research Data by : Institute of Medicine

Download or read book Sharing Clinical Research Data written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-07 with total page 157 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets. This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.