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Sharing Clinical Research Data
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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 304 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.
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.
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.
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 274 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 :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)
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.
Book Synopsis Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age by : Institute of Medicine
Download or read book Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age written by Institute of Medicine and published by National Academies Press. This book was released on 2009-11-17 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: As digital technologies are expanding the power and reach of research, they are also raising complex issues. These include complications in ensuring the validity of research data; standards that do not keep pace with the high rate of innovation; restrictions on data sharing that reduce the ability of researchers to verify results and build on previous research; and huge increases in the amount of data being generated, creating severe challenges in preserving that data for long-term use. Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age examines the consequences of the changes affecting research data with respect to three issues - integrity, accessibility, and stewardship-and finds a need for a new approach to the design and the management of research projects. The report recommends that all researchers receive appropriate training in the management of research data, and calls on researchers to make all research data, methods, and other information underlying results publicly accessible in a timely manner. The book also sees the stewardship of research data as a critical long-term task for the research enterprise and its stakeholders. Individual researchers, research institutions, research sponsors, professional societies, and journals involved in scientific, engineering, and medical research will find this book an essential guide to the principles affecting research data in the digital age.
Book Synopsis Clinical Data as the Basic Staple of Health Learning by : Institute of Medicine
Download or read book Clinical Data as the Basic Staple of Health Learning written by Institute of Medicine and published by National Academies Press. This book was released on 2011-01-14 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: Successful development of clinical data as an engine for knowledge generation has the potential to transform health and health care in America. As part of its Learning Health System Series, the Roundtable on Value & Science-Driven Health Care hosted a workshop to discuss expanding the access to and use of clinical data as a foundation for care improvement.
Book Synopsis Clinical Research Computing by : Prakash Nadkarni
Download or read book Clinical Research Computing written by Prakash Nadkarni and published by Academic Press. This book was released on 2016-04-29 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Research Computing: A Practitioner’s Handbook deals with the nuts-and-bolts of providing informatics and computing support for clinical research. The subjects that the practitioner must be aware of are not only technological and scientific, but also organizational and managerial. Therefore, the author offers case studies based on real life experiences in order to prepare the readers for the challenges they may face during their experiences either supporting clinical research or supporting electronic record systems. Clinical research computing is the application of computational methods to the broad field of clinical research. With the advent of modern digital computing, and the powerful data collection, storage, and analysis that is possible with it, it becomes more relevant to understand the technical details in order to fully seize its opportunities. Offers case studies, based on real-life examples where possible, to engage the readers with more complex examples Provides studies backed by technical details, e.g., schema diagrams, code snippets or algorithms illustrating particular techniques, to give the readers confidence to employ the techniques described in their own settings Offers didactic content organization and an increasing complexity through the chapters
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309378125 Total Pages :102 pages Book Rating :4.3/5 (93 download)
Book Synopsis Sharing Research Data to Improve Public Health in Africa by : National Academies of Sciences, Engineering, and Medicine
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 102 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 :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :030967915X Total Pages :163 pages Book Rating :4.3/5 (96 download)
Book Synopsis Reflections on Sharing Clinical Trial Data by : National Academies of Sciences, Engineering, and Medicine
Download or read book Reflections on Sharing Clinical Trial Data written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-11-20 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: On November 18 and 19, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop in Washington, DC, titled Sharing Clinical Trial Data: Challenges and a Way Forward. The workshop followed the release of the 2015 Institute of Medicine (IOM) consensus study report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, and was designed to examine the current state of clinical trial data sharing and reuse and to consider ways in which policy, technology, incentives, and governance could be leveraged to further encourage and enhance data sharing. This publication summarizes the presentations and discussions from the workshop.
Book Synopsis Clinical Trials with Missing Data by : Michael O'Kelly
Download or read book Clinical Trials with Missing Data written by Michael O'Kelly and published by John Wiley & Sons. This book was released on 2014-02-14 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides practical guidance for statisticians, clinicians, and researchers involved in clinical trials in the biopharmaceutical industry, medical and public health organisations. Academics and students needing an introduction to handling missing data will also find this book invaluable. The authors describe how missing data can affect the outcome and credibility of a clinical trial, show by examples how a clinical team can work to prevent missing data, and present the reader with approaches to address missing data effectively. The book is illustrated throughout with realistic case studies and worked examples, and presents clear and concise guidelines to enable good planning for missing data. The authors show how to handle missing data in a way that is transparent and easy to understand for clinicians, regulators and patients. New developments are presented to improve the choice and implementation of primary and sensitivity analyses for missing data. Many SAS code examples are included – the reader is given a toolbox for implementing analyses under a variety of assumptions.
Book Synopsis Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop by : National Academies Of Sciences Engineeri
Download or read book Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop written by National Academies Of Sciences Engineeri and published by National Academies Press. This book was released on 2022-08-09 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world settings; and new modalities, such as digital health technologies and artificial intelligence applications, are being leveraged to overcome challenges and advance clinical research. At the same time, the clinical research enterprise is strained by rising costs, varying global regulatory and economic landscapes, increasing complexity of clinical trials, barriers to recruitment and retention of research participants, and a clinical research workforce that is under tremendous demands. Looking ahead to 2030, the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine convened a public workshop for stakeholders from across the drug research and development life cycle to reflect on the lessons learned over the past 10 years and consider opportunities for the future. The workshop was designed to consider goals and priority action items that could advance the vision of a 2030 clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health care delivery system so that outcomes and experiences for all stakeholders are improved. This Proceedings of a Workshop summarizes the presentations and discussions that took place during the four-part virtual public workshop held on January 26, February 9, March 24, and May 11, 2021.
Book Synopsis Clinical Research Informatics by : Rachel Richesson
Download or read book Clinical Research Informatics written by Rachel Richesson and published by Springer Science & Business Media. This book was released on 2012-02-15 with total page 415 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings.
Book Synopsis Open Scientific Data by : Vera Lipton
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 :Lawrence M. Friedman Publisher :Springer Science & Business Media ISBN 13 :9780387985862 Total Pages :384 pages Book Rating :4.9/5 (858 download)
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.
Book Synopsis The Case for International Sharing of Scientific Data by : National Research Council
Download or read book The Case for International Sharing of Scientific Data written by National Research Council and published by National Academies Press. This book was released on 2013-01-11 with total page 181 pages. Available in PDF, EPUB and Kindle. Book excerpt: The theme of this international symposium is the promotion of greater sharing of scientific data for the benefit of research and broader development, particularly in the developing world. This is an extraordinarily important topic. Indeed, I have devoted much of my own career to matters related to the concept of openness. I had the opportunity to promote and help build the open courseware program at the Massachusetts Institute of Technology (MIT). This program has made the teaching materials for all 2,000 subjects taught at MIT available on the Web for anyone, anywhere, to use anytime at no cost. In countries where basic broadband was not available, we shipped it in on hard drives and compact disks. Its impact has been worldwide, but it has surely had the greatest impact on the developing world. I am also a trustee of a nonprofit organization named Ithaca that operates Journal Storage (JSTOR) and other entities that make scholarly information available at very low cost. The culture of science has been international and open for centuries. Indeed, the scientific enterprise can only work when all information is open and accessible, because science works through critical analysis and replication of results. In recent years, as some scientific data, and especially technological data, have increased in economic value frequently has caused us to be far less open with information than business and free enterprise require us to be. Indeed, the worldwide shift to what is known as open innovation is strengthening every day. Finally, since the end of World War II, the realities of modern military conflict and now terrorism have led governments to restrict information through classification. This is important, but I believe that we classify far too much information. The last thing we need today, at the beginning of the twenty-first century, is further arbitrary limitations on the free flow of scientific information, whether by policies established by governments and businesses, or by lack of information infrastructure. For all these reasons, the international sharing of scientific data is one of the topics of great interest here at the National Academies and has been the subject of many of our past reports. This is the primary reason why this symposium has been co-organized by the NRC's Policy and Global Affairs Division-the Board on International Scientific Organizations (BISO) and the Board on Research Data and Information (BRDI). The Case for International Sharing of Scientific Data: A Focus on Developing Countries: Proceedings of a Symposium summarizes the symposium.
Book Synopsis Validating Clinical Trial Data Reporting with SAS by : Carol I. Matthews
Download or read book Validating Clinical Trial Data Reporting with SAS written by Carol I. Matthews and published by SAS Institute. This book was released on 2008 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: This indispensable guide focuses on validating programs written to support the clinical trial process from after the data collection stage to generating reports and submitting data and output to the Food and Drug Administration.
