Data Sharing and Secondary Use of Scientific Data PDF Download

Author: Ann S. Zimmerman
Publisher:
ISBN:
Category : Ecology
Languages : en
Pages : 572

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Book Description

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236

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Book Description
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: 0309268745
Category : Medical
Languages : en
Pages : 157

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Book Description
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: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309378125
Category : Science
Languages : en
Pages : 126

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Book Description
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: Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher:
ISBN: 9780309297790
Category : Clinical trials
Languages : en
Pages : 0

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Book Description
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: Louise Corti
Publisher: SAGE
ISBN: 144629773X
Category : Social Science
Languages : en
Pages : 258

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Book Description
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: Vera J. Lipton
Publisher:
ISBN: 9781838809867
Category : Big data
Languages : en
Pages :

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Book Description
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: Victoria Stodden
Publisher: CRC Press
ISBN: 1466561599
Category : Mathematics
Languages : en
Pages : 450

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Book Description
In computational science, reproducibility requires that researchers make code and data available to others so that the data can be analyzed in a similar manner as in the original publication. Code must be available to be distributed, data must be accessible in a readable format, and a platform must be available for widely distributing the data and code. In addition, both data and code need to be licensed permissively enough so that others can reproduce the work without a substantial legal burden. Implementing Reproducible Research covers many of the elements necessary for conducting and distributing reproducible research. It explains how to accurately reproduce a scientific result. Divided into three parts, the book discusses the tools, practices, and dissemination platforms for ensuring reproducibility in computational science. It describes: Computational tools, such as Sweave, knitr, VisTrails, Sumatra, CDE, and the Declaratron system Open source practices, good programming practices, trends in open science, and the role of cloud computing in reproducible research Software and methodological platforms, including open source software packages, RunMyCode platform, and open access journals Each part presents contributions from leaders who have developed software and other products that have advanced the field. Supplementary material is available at www.ImplementingRR.org.

Author: Marcelo Corrales Compagnucci
Publisher: Springer Nature
ISBN: 9819965403
Category : Law
Languages : en
Pages : 211

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Book Description
Data sharing – broadly defined as the exchange of health-related data among multiple controllers and processors – has gained increased relevance in the health sciences over recent years as the need and demand for collaboration has increased. This includes data obtained through healthcare provisions, clinical trials, observational studies, public health surveillance programs, and other data collection methods. The practice of data sharing presents several notable challenges, however. Compliance with a complex and dynamic regulatory framework is essential, with the General Data Protection Regulation being a prominent example in a European context. Recent regulatory developments related to clinical trial transparency, trade secrecy, data access, AI training data, and health data spaces further contribute to the difficulties. Simultaneously, government initiatives often encourage scientists to embrace principles of “open data” and “open innovation.” The variety of regulations in this domain has the potential to impede widespread data sharing and hinder innovation. This edited volume, therefore, compiles comparative case studies authored by leading scholars from diverse disciplines and jurisdictions. The book aims to outline the legal complexities of data sharing. By examining real-world scenarios from diverse disciplines and a global perspective, it explores the normative, policy, and ethical dilemmas that surround data sharing in the health sciences today. Chapter Patient Perspectives on Data Sharing, Chapter Supplementary Measures and Appropriate Safeguards for International Transfers of Health Data after Schrems II are available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.

Author: MIT Critical Data
Publisher: Springer
ISBN: 3319437429
Category : Medical
Languages : en
Pages : 435

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Book Description
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.