Sharing Clinical Trial Data

Sharing Clinical Trial Data
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 236
Release: 2015-04-20
Genre: Medical
ISBN: 0309316324

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 and Obstacles for Sharing Data from Environmental Health Research

Principles and Obstacles for Sharing Data from Environmental Health Research
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 115
Release: 2016-05-29
Genre: Science
ISBN: 030937085X

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.

Cyber Security and Digital Forensics

Cyber Security and Digital Forensics
Author: Sabyasachi Pramanik
Publisher: John Wiley & Sons
Total Pages: 300
Release: 2022-01-12
Genre: Computers
ISBN: 1119795648

CYBER SECURITY AND DIGITAL FORENSICS Cyber security is an incredibly important issue that is constantly changing, with new methods, processes, and technologies coming online all the time. Books like this are invaluable to professionals working in this area, to stay abreast of all of these changes. Current cyber threats are getting more complicated and advanced with the rapid evolution of adversarial techniques. Networked computing and portable electronic devices have broadened the role of digital forensics beyond traditional investigations into computer crime. The overall increase in the use of computers as a way of storing and retrieving high-security information requires appropriate security measures to protect the entire computing and communication scenario worldwide. Further, with the introduction of the internet and its underlying technology, facets of information security are becoming a primary concern to protect networks and cyber infrastructures from various threats. This groundbreaking new volume, written and edited by a wide range of professionals in this area, covers broad technical and socio-economic perspectives for the utilization of information and communication technologies and the development of practical solutions in cyber security and digital forensics. Not just for the professional working in the field, but also for the student or academic on the university level, this is a must-have for any library. Audience: Practitioners, consultants, engineers, academics, and other professionals working in the areas of cyber analysis, cyber security, homeland security, national defense, the protection of national critical infrastructures, cyber-crime, cyber vulnerabilities, cyber-attacks related to network systems, cyber threat reduction planning, and those who provide leadership in cyber security management both in public and private sectors

Genomic Data Sharing

Genomic Data Sharing
Author: Jennifer B. Mccormick
Publisher: Academic Press
Total Pages: 232
Release: 2022-11-29
Genre: Medical
ISBN: 0128198044

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

Reflections on Sharing Clinical Trial Data

Reflections on Sharing Clinical Trial Data
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 163
Release: 2020-10-20
Genre: Medical
ISBN: 0309679184

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.

Fostering Collaborative Data Exchange Using Semantic Data Models In The European Goods Transport Industry

Fostering Collaborative Data Exchange Using Semantic Data Models In The European Goods Transport Industry
Author: Andreas Pelekies
Publisher: diplom.de
Total Pages: 180
Release: 2020-11-28
Genre: Business & Economics
ISBN: 3961163928

For more than 20 years, supply chains have been optimized using electronic data interchange based on the EDIFACT standard. In 2010, the EU Commission launched a digital agenda to optimize public administration processes through uniform and cross-border regulations. Ongoing globalization and increased environmental awareness are creating increasing de-mands for the transport industry, such as shifting transport from road to rail. Several projects are focusing on the semantic standardization of data exchange based on web technologies, in order to optimize system interaction between all players of the transport supply chain. This study investigates, if using a semantic reference data model instead of a proprietary data model fosters the intensity of possible interactions of data exchange systems in the European goods transport industry. To be able to measure a change drivers, benefits, challenges, and success factors for collaborative data exchange are identified. The research in this study bases its solutions on the system interaction theory and performs a literature review as well as collects primary data. Six representatives of important players of the European goods transport industry are interviewed and surveyed.

Blockchain: Empowering Secure Data Sharing

Blockchain: Empowering Secure Data Sharing
Author: Meng Shen
Publisher: Springer Nature
Total Pages: 135
Release: 2020-07-15
Genre: Computers
ISBN: 9811559392

With the development of big data, data sharing has become increasingly popular and important in optimizing resource allocation and improving information utilization. However, the expansion of data sharing means there is an urgent need to address the issue of the privacy protection – an area where the emerging blockchain technology offers considerable advantages. Although there are a large number of research papers on data sharing modeling and analysis of network security, there are few books dedicated to blockchain-based secure data sharing. Filing this gap in the literature, the book proposes a new data-sharing model based on the blockchain system, which is being increasingly used in medical and credit reporting contexts. It describes in detail various aspects of the model, including its role, transaction structure design, secure multi-party computing and homomorphic encryption services, and incentive mechanisms, and presents corresponding case studies. The book explains the security architecture model and the practice of building data sharing from the blockchain infrastructure, allowing readers to understand the importance of data sharing security based on the blockchain framework, as well as the threats to security and privacy. Further, by presenting specific data sharing case studies, it offers insights into solving data security sharing problems in more practical fields. The book is intended for readers with a basic understanding of the blockchain infrastructure, consensus mechanisms, smart contracts, secure multiparty computing, homomorphic encryption and image retrieval technologies.

Research Data Sharing and Valorization

Research Data Sharing and Valorization
Author: Joachim Schöpfel
Publisher: John Wiley & Sons
Total Pages: 276
Release: 2022-09-21
Genre: Computers
ISBN: 178945073X

As platforms for sharing, re-using and storing data, research data repositories are integral to open science policy. This book provides a comprehensive approach to these data repositories, their functionalities, uses, issues and prospects. Taking France as an example, the current landscape of data repositories is considered, including discussion of the idea of a national repository and a comparative study of several national systems. The international re3data directory is outlined and a collection of six case studies of model repositories, both public and private, are detailed (CDS, Data INRAE, SEANOE, Nakala, Figshare and Data Mendeley). Research Data Sharing and Valorization also includes appendices containing a number of websites and reference texts from the French Ministry of Higher Education, Research and Innovation, and the CNRS. To the authors’ knowledge, it is the first book to be entirely devoted to these new platforms and is aimed at researchers, teachers, students and professionals working with scientific and technical data and information.