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.

Principles of Data Management

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Publisher : BCS, The Chartered Institute for IT
ISBN 13 : 9781780171845
Total Pages : 250 pages
Book Rating : 4.1/5 (718 download)

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Book Synopsis Principles of Data Management by : Keith Gordon

Download or read book Principles of Data Management written by Keith Gordon and published by BCS, The Chartered Institute for IT. This book was released on 2013-11-18 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data is a valuable corporate asset and its effective management can be vital to an organisation’s success. This professional guide covers all the key areas of data management, including database development and corporate data modelling. It is business-focused, providing the knowledge and techniques required to successfully implement the data management function. This new edition covers web technology and its relation to databases and includes material on the management of master data.

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.

Facilitating Data Sharing

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Author :
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (16 download)

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Book Synopsis Facilitating Data Sharing by : Kristian Garza Gutierrez

Download or read book Facilitating Data Sharing written by Kristian Garza Gutierrez and published by . This book was released on 2017 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Discussion Framework for Clinical Trial Data Sharing

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Publisher :
ISBN 13 : 9780309297790
Total Pages : 0 pages
Book Rating : 4.2/5 (977 download)

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Book Synopsis Discussion Framework for Clinical Trial Data Sharing by : Committee on Strategies for Responsible Sharing of Clinical Trial Data

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.

Enhancing Access to and Sharing of Data Reconciling Risks and Benefits for Data Re-use across Societies

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Author :
Publisher : OECD Publishing
ISBN 13 : 9264660658
Total Pages : 138 pages
Book Rating : 4.2/5 (646 download)

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Book Synopsis Enhancing Access to and Sharing of Data Reconciling Risks and Benefits for Data Re-use across Societies by : OECD

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.

Managing and Sharing Research Data

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Author :
Publisher : SAGE
ISBN 13 : 144629773X
Total Pages : 258 pages
Book Rating : 4.4/5 (462 download)

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Book Synopsis Managing and Sharing Research Data by : Louise Corti

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.

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.

Principles and Obstacles for Sharing Data from Environmental Health Research

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Author :
Publisher : National Academies Press
ISBN 13 : 030937085X
Total Pages : 115 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Principles and Obstacles for Sharing Data from Environmental Health Research by : National Academies of Sciences, Engineering, and Medicine

Download or read book Principles and Obstacles for Sharing Data from Environmental Health Research written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-05-29 with total page 115 pages. Available in PDF, EPUB and Kindle. Book excerpt: On March 19, 2014, the National Academies of Sciences, Engineering, and Medicine held a workshop on the topic of the sharing of data from environmental health research. Experts in the field of environmental health agree that there are benefits to sharing research data, but questions remain regarding how to effectively make these data available. The sharing of data derived from human subjects-making them both transparent and accessible to others-raises a host of ethical, scientific, and process questions that are not always present in other areas of science, such as physics, geology, or chemistry. The workshop participants explored key concerns, principles, and obstacles to the responsible sharing of data used in support of environmental health research and policy making while focusing on protecting the privacy of human subjects and addressing the concerns of the research community. Principles and Obstacles for Sharing Data from Environmental Health Research summarizes the presentations and discussions from the workshop.

Mapping the Determinants of Spatial Data Sharing

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Author :
Publisher : Routledge
ISBN 13 : 1351769308
Total Pages : 295 pages
Book Rating : 4.3/5 (517 download)

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Book Synopsis Mapping the Determinants of Spatial Data Sharing by : Uta Wehn de Montalvo

Download or read book Mapping the Determinants of Spatial Data Sharing written by Uta Wehn de Montalvo and published by Routledge. This book was released on 2017-11-01 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title was first published in 2003. With the increasing use of GIS in industrialised and developing countries, the availability of spatial data has become an issue that affects many public and private sector organisations. They are faced with the high cost and substantial effort involved in the generation of spatial data and so the sharing of this data is increasingly being seen as a way of overcoming expense and easing availability and access. But this can provide a way of using GIS effectively only if the key players involved in the use and supply of spatial data are willing to share. This book employs a theory from social psychology as an organising framework to systematize the determinants of organisations' spatial data sharing behaviour. It develops a model which explains the likely willingness of key individuals within organisations to engage in spatial data exchanges across organisational boundaries and then tests this on a survey based in South Africa.

Practical Tips for Facilitating Research

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Publisher : Facet Publishing
ISBN 13 : 1783300175
Total Pages : 289 pages
Book Rating : 4.7/5 (833 download)

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Book Synopsis Practical Tips for Facilitating Research by : Moira J. Bent

Download or read book Practical Tips for Facilitating Research written by Moira J. Bent and published by Facet Publishing. This book was released on 2016-03-16 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide offers innovative tips and reliable best practice to enable new and experienced library and information professionals to evaluate their current provision and develop their service to meet the evolving needs of the research community. Interacting effectively with information is at the heart of all research, consequently information professionals have a key role to play in facilitating the development of researchers who are able to operate confidently and successfully in the information world. Grounded in current theory and informed by practitioners from around the world, this practical book offers a wide range of ideas and methods to assist library and information professionals in developing and managing their role in the research environment. Part of the Practical Tips for Library and Information Professionals series, the book is organised into eight sections: landscapes and models structures and strategies places and spaces library staff roles collections specific interventions in the research process or lifecycle teaching approaches information literacy skills workshops and programmes. Practical Tips for Facilitating Research will be essential reading for academic liaison librarians, research support librarians and all library and information professionals who work with research staff and students.

Facilitating Community Research for Social Change

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Publisher : Routledge
ISBN 13 : 1000568520
Total Pages : 321 pages
Book Rating : 4.0/5 (5 download)

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Book Synopsis Facilitating Community Research for Social Change by : Casey Burkholder

Download or read book Facilitating Community Research for Social Change written by Casey Burkholder and published by Routledge. This book was released on 2022-03-31 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: Facilitating Community Research for Social Change asks: what does ethical research facilitation look like in projects that seek to move toward social change? How can scholars weave political and social justice through multiple levels of the research process? This edited collection presents chapters that investigate research facilitation in ways that specifically attempt to disrupt and challenge anti-Indigenous and anti-Black racism, ableism, homophobia, transphobia, patriarchy, and sexism to work toward social change. It also explores what it means to develop facilitation practices across multiple contexts and research settings, including specific facilitation methods considered by researchers working with visual and community-based methods with Black, Indigenous, and racialized communities. The complexities of how scholars negotiate decisions within their research with people and communities have an effect not only on how researchers construct their participants and communities, but also on the overall purpose of projects, the ways their projects are shared and disseminated, and what is learned in the doing of facilitation. This book will be of great interest to both emerging and established researchers working within the social sciences. It specifically attends to diverse fields within the social sciences that include health, media studies, environmental studies, social work, sociology, education, participatory visual research methodologies, as well as the evolving field of digital humanities.

Genomic Data Sharing

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Publisher : Academic Press
ISBN 13 : 0128198044
Total Pages : 232 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Genomic Data Sharing by : Jennifer B. Mccormick

Download or read book Genomic Data Sharing written by Jennifer B. Mccormick and published by Academic Press. This book was released on 2022-11-29 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genomic Data Sharing: Case Studies, Challenges, and Opportunities for Precision Medicine provides a comprehensive overview of current and emerging issues in genomic data sharing. In this book, international leaders in genomic data examine these issues in-depth, offering practical case studies that highlight key successes, challenges and opportunities. Sections discuss the eMERGE Network, Undiagnosed Disease Network, Vanderbilt Biobank, Marshfield Clinic Biobank, Minnesota Authorization, Rochester Epidemiology Project, NIH sponsored biobanks, GINA, and Global Alliance for Genomics and Health (GA4GH). In addition to these perspectives from the frontlines, the book also provides succinct overviews of ethical, legal, social and IT challenges. Clinician investigators, clinicians affiliated with academic medical centers, policymakers and regulators will also gain insights that will allow them to navigate the increasingly complex ethical, social and clinical landscape of genomic data sharing. Covers both technical and ELSI (ethical, legal, and social implications) perspectives on genomic data sharing Includes applied case studies of existing genomic data sharing consortia, including the eMERGE Network, Undiagnosed Disease Network, and the Global Alliance for Genomics and Health (GA4GH), among others Features chapter contributions from international leaders in genomic data sharing

Facilitating Interdisciplinary Research

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Publisher : National Academies Press
ISBN 13 : 0309165482
Total Pages : 332 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Facilitating Interdisciplinary Research by : Institute of Medicine

Download or read book Facilitating Interdisciplinary Research written by Institute of Medicine and published by National Academies Press. This book was released on 2005-04-04 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Facilitating Interdisciplinary Research examines current interdisciplinary research efforts and recommends ways to stimulate and support such research. Advances in science and engineering increasingly require the collaboration of scholars from various fields. This shift is driven by the need to address complex problems that cut across traditional disciplines, and the capacity of new technologies to both transform existing disciplines and generate new ones. At the same time, however, interdisciplinary research can be impeded by policies on hiring, promotion, tenure, proposal review, and resource allocation that favor traditional disciplines. This report identifies steps that researchers, teachers, students, institutions, funding organizations, and disciplinary societies can take to more effectively conduct, facilitate, and evaluate interdisciplinary research programs and projects. Throughout the report key concepts are illustrated with case studies and results of the committee's surveys of individual researchers and university provosts.

Facilitating Medical Product Development Through Voluntary Data Sharing

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Publisher :
ISBN 13 :
Total Pages : 51 pages
Book Rating : 4.:/5 (13 download)

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Book Synopsis Facilitating Medical Product Development Through Voluntary Data Sharing by : Aliza Glasner

Download or read book Facilitating Medical Product Development Through Voluntary Data Sharing written by Aliza Glasner and published by . This book was released on 2015 with total page 51 pages. Available in PDF, EPUB and Kindle. Book excerpt: The generation, dissemination, and sharing of research data are key ingredients in contributing to scientific progress and the public good. Data sharing has been encouraged to facilitate open science within the clinical research enterprise, improve the development of drugs and devices, and benefit public health. To date, the subject has received considerable attention in the media and scientific literature, however focused mainly on philosophical arguments. Of the empirical research that exists, much of it has focused on data sharing among academic investigators in the field of life science, including biomedical research, medicine, and genetics. A number of commentaries and editorials have dealt with the ethical repercussions when researchers choose not to share data; others have discussed real or perceived legal barriers to data sharing. These barriers include (1) compromised intellectual property rights and unfair advantages to competitors, (2) risk of increased product liability, (3) issues of collusion under antitrust laws, and (4) risks to research participant privacy. This report examines the legal issues that may pose barriers to data sharing. The report provides a helpful guide to those in the biomedical community who wish to engage in data sharing. In each section, the authors provide an overview of the legal issue, including the statutes and other background, and suggest approaches for surmounting legal issues.

Principles of Data Management

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Author :
Publisher : BCS, The Chartered Institute
ISBN 13 :
Total Pages : 284 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Principles of Data Management by : Keith Gordon

Download or read book Principles of Data Management written by Keith Gordon and published by BCS, The Chartered Institute. This book was released on 2007 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Organisations increasingly view data as a valuable corporate asset and its effective management can be vital to an organisation's success. This professional reference guide covers all the key areas including database development, data quality and corporate data modelling. It is not based on a particular proprietary system; it is business focused, providing the knowledge and techniques required to successfully implement the data management function.

Principles of Data Management

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Author :
Publisher :
ISBN 13 : 9781628702606
Total Pages : 249 pages
Book Rating : 4.7/5 (26 download)

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Book Synopsis Principles of Data Management by : Keith Gordon

Download or read book Principles of Data Management written by Keith Gordon and published by . This book was released on 2013 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data is a valuable corporate asset and its effective management can be vital to success. This professional guide covers all the key areas of data management, including database development and corporate data modelling. The new edition covers web technology and its relation to databases and includes material on the management of master data.