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Author : Ann S. Zimmerman
Publisher :
ISBN 13 :
Total Pages : 572 pages
Book Rating : 4.3/5 (91 download)
Download or read book Data Sharing and Secondary Use of Scientific Data written by Ann S. Zimmerman and published by . This book was released on 2003 with total page 572 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)
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.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309268745
Total Pages : 157 pages
Book Rating : 4.3/5 (92 download)
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.
Author : Louise Corti
Publisher : SAGE
ISBN 13 : 144629773X
Total Pages : 258 pages
Book Rating : 4.4/5 (462 download)
Download or read book Managing and Sharing Research Data written by Louise Corti and published by SAGE. This book was released on 2014-02-04 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research funders in the UK, USA and across Europe are implementing data management and sharing policies to maximize openness of data, transparency and accountability of the research they support. Written by experts from the UK Data Archive with over 20 years experience, this book gives post-graduate students, researchers and research support staff the data management skills required in today’s changing research environment. The book features guidance on: how to plan your research using a data management checklist how to format and organize data how to store and transfer data research ethics and privacy in data sharing and intellectual property rights data strategies for collaborative research how to publish and cite data how to make use of other people’s research data, illustrated with six real-life case studies of data use.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309378125
Total Pages : 126 pages
Book Rating : 4.3/5 (93 download)
Download or read book Sharing Research Data to Improve Public Health in Africa written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2015-09-18 with total page 126 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sharing research data on public health issues can promote expanded scientific inquiry and has the potential to advance improvements in public health. Although sharing data is the norm in some research fields, sharing of data in public health is not as firmly established. In March 2015, the National Research Council organized an international conference in Stellenbosch, South Africa, to explore the benefits of and barriers to sharing research data within the African context. The workshop brought together public health researchers and epidemiologists primarily from the African continent, along with selected international experts, to talk about the benefits and challenges of sharing data to improve public health, and to discuss potential actions to guide future work related to public health research data sharing. Sharing Research Data to Improve Public Health in Africa summarizes the presentations and discussions from this workshop.
Author : MIT Critical Data
Publisher : Springer
ISBN 13 : 3319437429
Total Pages : 435 pages
Book Rating : 4.3/5 (194 download)
Download or read book Secondary Analysis of Electronic Health Records written by MIT Critical Data and published by Springer. This book was released on 2016-09-09 with total page 435 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book trains the next generation of scientists representing different disciplines to leverage the data generated during routine patient care. It formulates a more complete lexicon of evidence-based recommendations and support shared, ethical decision making by doctors with their patients. Diagnostic and therapeutic technologies continue to evolve rapidly, and both individual practitioners and clinical teams face increasingly complex ethical decisions. Unfortunately, the current state of medical knowledge does not provide the guidance to make the majority of clinical decisions on the basis of evidence. The present research infrastructure is inefficient and frequently produces unreliable results that cannot be replicated. Even randomized controlled trials (RCTs), the traditional gold standards of the research reliability hierarchy, are not without limitations. They can be costly, labor intensive, and slow, and can return results that are seldom generalizable to every patient population. Furthermore, many pertinent but unresolved clinical and medical systems issues do not seem to have attracted the interest of the research enterprise, which has come to focus instead on cellular and molecular investigations and single-agent (e.g., a drug or device) effects. For clinicians, the end result is a bit of a “data desert” when it comes to making decisions. The new research infrastructure proposed in this book will help the medical profession to make ethically sound and well informed decisions for their patients.
Author : Steven Piantadosi
Publisher : Springer Nature
ISBN 13 : 3319526367
Total Pages : 2573 pages
Book Rating : 4.3/5 (195 download)
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.
Author : OECD
Publisher : OECD Publishing
ISBN 13 : 9264660658
Total Pages : 138 pages
Book Rating : 4.2/5 (646 download)
Download or read book Enhancing Access to and Sharing of Data Reconciling Risks and Benefits for Data Re-use across Societies written by OECD and published by OECD Publishing. This book was released on 2019-11-26 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report examines the opportunities of enhancing access to and sharing of data (EASD) in the context of the growing importance of artificial intelligence and the Internet of Things. It discusses how EASD can maximise the social and economic value of data re-use and how the related risks and challenges can be addressed. It highlights the trade-offs, complementarities and possible unintended consequences of policy action – and inaction. It also provides examples of EASD approaches and policy initiatives in OECD countries and partner economies.
Author : Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher :
ISBN 13 : 9780309297790
Total Pages : 0 pages
Book Rating : 4.2/5 (977 download)
Download or read book Discussion Framework for Clinical Trial Data Sharing written by Committee on Strategies for Responsible Sharing of Clinical Trial Data and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sharing data generated through the conduct of clinical trials offers the promise of placing evidence about the safety and efficacy of therapies and clinical interventions on a firmer basis and enhancing the benefits of clinical trials. Ultimately, such data sharing - if carried out appropriately - could lead to improved clinical care and greater public trust in clinical research and health care. Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities is part of a study of how data from clinical trials might best be shared. This document is designed as a framework for discussion and public comment. This framework is being released to stimulate reactions and comments from stakeholders and the public. The framework summarizes the committee's initial thoughts on guiding principles that underpin responsible sharing of clinical trial data, defines key elements of clinical trial data and data sharing, and describes a selected set of clinical trial data sharing activities.
Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)
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.
Author : Kali H. Trzesniewski
Publisher : American Psychological Association (APA)
ISBN 13 :
Total Pages : 264 pages
Book Rating : 4.3/5 (97 download)
Download or read book Secondary Data Analysis written by Kali H. Trzesniewski and published by American Psychological Association (APA). This book was released on 2011 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: This wide-ranging yet practical book shows how the analysis of secondary data can provide unique opportunities for advancing psychological science. --Book Jacket.
Author : Vera J. Lipton
Publisher :
ISBN 13 : 9781838809867
Total Pages : pages
Book Rating : 4.8/5 (98 download)
Download or read book Open Scientific Data written by Vera J. Lipton and published by . This book was released on 2020 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Public science is critical to the economy and to society. However, much of the beneficial impact of scientific research only occurs when scientific knowledge is disseminated broadly and is used by others. This book examines the emerging policy, law and practice of facilitating open access to scientific research data. One particular focus is to examine the open data policies recently introduced by research funders and publishers, and the potential in these for driving the practice of open scientific data into the future. This study identifies five major stumbling blocks to sustainable open scientific data. Firstly, it is the prevailing mindset that facilitating open access to data is analogous to facilitating open access to publications and, therefore, research data can easily be shared, with research funders and librarians effectively leading the process. Secondly, it is the unclear meaning of the term data which causes confusion among stakeholders. Thirdly, it is the misunderstood incentives for data sharing and the additional inputs required from researchers. Fourthly, data privacy—an issue that only applies to selected research datasets, and yet appears to dominate the discussion about open research data. Finally, there is a copyright law, which poses challenges at different stages of data release and reuse. In this book, it is argued that the above problems can be addressed using a staged model for open scientific data. I draw specifically on the practice with open scientific data at CERN (the European Organization for Nuclear Research) and the practice of sharing clinical trial data to argue that open data can be shared at various stages of processing and diversification. This model is supplemented by recommendations proposing changes to existing open data mandates and the introduction of a text and data mining exemption into Australian copyright law.
Author : Jasna Markovac
Publisher : Academic Press
ISBN 13 : 0128099704
Total Pages : 358 pages
Book Rating : 4.1/5 (28 download)
Download or read book Medical and Scientific Publishing written by Jasna Markovac and published by Academic Press. This book was released on 2017-11-13 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: Very few doctors and scientists receive any sort of systematic training in publishing, editing, and reviewing scholarly articles, despite the central importance of that work for scientific research and for their careers. Medical and Scientific Publishing will help fill the gap and help readers to: Understand processes of scientific and medical publishing Understand the role of an academic in medical publishing Become a better scientific communicator Develop skills to effectively serve as the editor of a medical journal Medical and Scientific Publishing is based on a successful course at the University of Michigan Medical School for third and fourth year medical students. The course teaches students not just how to write scientific and medical articles, but addresses key issues surrounding copyright, ethics, open access and much more. Students will build a strong foundation on how to do peer review and how to be authors and editors which are important skills in building a professional career. - Covers a full range of essential information – explanation of publishing licenses, copyright and permissions, how to do peer review, how to write effectively, how journal publishing works, and much more - Emphasizes rigor, quality, and scientific integrity in writing, editing, and publishing - Focuses on authorship and editorial skills by experienced authors and publishers
Author : Joan E. Sieber
Publisher : SAGE Publications
ISBN 13 : 1452252912
Total Pages : 177 pages
Book Rating : 4.4/5 (522 download)
Download or read book Sharing Social Science Data written by Joan E. Sieber and published by SAGE Publications. This book was released on 1991-02-12 with total page 177 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although major funding agencies now require social scientists to share their documented raw data, scientists have been reluctant to comply. The reasons include unwillingness to divulge all of the conditions under which the data were generated, cost in time and money, and the desire by social scientists to carry the research further themselves. Data sharing, however, promises to foster more open, cost-effective and cumulative research, and to improve the quality of methodology, data and inference. Sharing Social Science Data presents the major accomplishments of social scientists who have pioneered in data sharing, highlighting the advantages for social science. It also includes an examination of the reasons for data sharing, the specific sharing practices in various disciplines, the factors affecting the usefulness of shared data (documentation, archiving, and marketing), and individual and institutional concerns about data sharing. A timely examination, this cohesive and well written volume will interest graduate students and researchers in all areas of the social sciences. ". . .the chapters are thoughtful and well written, and they address many of the crucial issues faced by the social sciences in the 1990s. . . .anyone who wants to help shape the future of the social and behavioral sciences can benefit from giving this book at least a quick read." --Contemporary Psychology
Author : Vera Lipton
Publisher : BoD – Books on Demand
ISBN 13 : 1838809848
Total Pages : 232 pages
Book Rating : 4.8/5 (388 download)
Download or read book Open Scientific Data written by Vera Lipton and published by BoD – Books on Demand. This book was released on 2020-01-22 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book shows how the vision for open access to scientific data can be more readily achieved through a staged model that research funders, policy makers, scientists, and research organizations can adopt in their practice. Drawing on her own experiences with data processing, on early findings with open scientific data at CERN (the European Organization for Nuclear Research), and from case studies of shared clinical trial data, the author updates our understanding of research data - what it is; how it dynamically evolves across different scientific disciplines and across various stages of research practice; and how it can, and indeed should, be shared at any of those stages. The result is a flexible and pragmatic path for implementing open scientific data.
Author : Willo Pequegnat
Publisher : Springer Science & Business Media
ISBN 13 : 1441914544
Total Pages : 401 pages
Book Rating : 4.4/5 (419 download)
Download or read book How to Write a Successful Research Grant Application written by Willo Pequegnat and published by Springer Science & Business Media. This book was released on 2010-11-02 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the last fifty years behavioral and medical research has been generously supported by the federal government, private foundations, and other philanthropic organizations contributing to the development of a vibrant public health system both in the United States and worldwide. However, these funds are dwindling and to stay competitive, investigators must understand the funding environment and know how to translate their hypotheses into research grant applications that reviewers evaluate as having scientific merit. The Second Edition of ‘How to Write a Successful Research Grant Application’ is the only book of its kind written by federal research investigators which provides technical assistance for researchers applying for biobehavioral and psychosocial research funding and can give them an edge in this competitive environment. The book provides invaluable tips on all aspects of the art of grantsmanship, including: how to determine research opportunities and priorities, how to develop the different elements of an application, how to negotiate the electronic submission and review processes, and how to disseminate the findings. Charts, visual aids, Web links, an extensive real-world example of a research proposal with budget, and a "So You Were Awarded Your Grant—Now What?" chapter show prospective applicants how to: - Formulate a testworthy—and interesting—hypothesis. - Select the appropriate research mechanism. - Avoid common pitfalls in proposal writing. - Develop an adequate control group. - Conduct a rigorous qualitative inquiry. - Develop a budget justification of costs. - Develop a human subjects of animal welfare plan. - Write a data analytic plan. - Design a quality control/assurance program. - Read between the lines of a summary of the review of your application. Although its focus is on Public Health Service funding, ‘How to Write a Successful Research Grant’ is equally useful for all research proposals, including graduate students preparing a thesis or dissertation proposal. Service providers in community-based organizations and public health agencies will also find this a useful resource in preparing a proposal to compete for grant funds from state and community resources, non-government organizations, and foundations.
Author : Sibinga, Cees Th. Smit
Publisher : IGI Global
ISBN 13 : 1522527311
Total Pages : 324 pages
Book Rating : 4.5/5 (225 download)
Download or read book Ensuring Research Integrity and the Ethical Management of Data written by Sibinga, Cees Th. Smit and published by IGI Global. This book was released on 2018-01-31 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data management technology is rapidly progressing, and with it comes the need for stricter rules that ensure the information being collected is handled appropriately. Ensuring Research Integrity and the Ethical Management of Data is an essential resource that examines the best approaches for providing quality research, as well as how to effectively manage that information in a reputable way. Featuring extensive research on relevant topics such as qualitative data collection, data sharing, data misinterpretation, and intellectual property, this scholarly publication is an ideal reference source for academicians, students, and researchers interested in current trends and techniques in ethical research and data management.
