Read Books Online and Download eBooks, EPub, PDF, Mobi, Kindle, Text Full Free.
Facilitating Medical Product Development Through Voluntary Data Sharing
Download Facilitating Medical Product Development Through Voluntary Data Sharing full books in PDF, epub, and Kindle. Read online Facilitating Medical Product Development Through Voluntary Data Sharing ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
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.
Book Synopsis Promoting access to medical technologies and innovation by :
Download or read book Promoting access to medical technologies and innovation written by and published by World Health Organization. This book was released on 2021-10-15 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade. by : World Intellectual Property Organization
Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade. written by World Intellectual Property Organization and published by WIPO. This book was released on 2020-07-28 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study seeks to reinforce the understanding of the interplay between the distinct policy domains of health, trade and intellectual property, and of how they affect medical innovation and access to medical technologies. The second edition comprehensively reviews new developments in key areas since the initial launch of the study in 2013.
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 Beyond the HIPAA Privacy Rule by : Institute of Medicine
Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Book Synopsis Nomination of Andrew von Eschenbach and Paul DeCamp : hearing by :
Download or read book Nomination of Andrew von Eschenbach and Paul DeCamp : hearing written by and published by DIANE Publishing. This book was released on with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Law and Ethics of Data Sharing in Health Sciences by : Marcelo Corrales Compagnucci
Download or read book The Law and Ethics of Data Sharing in Health Sciences written by Marcelo Corrales Compagnucci and published by Springer Nature. This book was released on 2024-01-02 with total page 211 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Handbook of Complementary, Alternative, and Integrative Medicine by : Yaser Mohammed Al-Worafi
Download or read book Handbook of Complementary, Alternative, and Integrative Medicine written by Yaser Mohammed Al-Worafi and published by CRC Press. This book was released on 2024-10-10 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: Six volumes combine to make up the Handbook of Complementary, Alternative, and Integrative Medicine: Education, Practice and Research, which describes the education, practice, and research-related issues of complementary, alternative, and integrative medicine; and its efficacy and safety in treating diseases and health conditions. Further the volumes review integrative medicine around the world to share the best practices and experiences in terms of education, practice and research; and identify the challenges and suggest recommendations to overcome them. The 20 chapters of Volume 2 focus on complementary, alternative, and integrative medicine practice-related issues. It begins with a history of complementary, alternative, and integrative medicine practice and continues with coverage of terminologies and types of complementary and alternative medicine and addresses regulations and laws around the world. It introduces integrative medicine-related issues and discusses herbal medicines and the herbal industry, including safety. Key Features: Explains the quality of complementary and alternative medicine practice and services Describes the continuous professional development (CPD) for CAM practitioners, facilitators, and barriers of online CPD Covers the technology-related issues in complementary and alternative medicine practice and services Describes the challenges of complementary, alternative, and integrative medicine practice and suggests recommendations to overcome them
Book Synopsis Journal of the House of Representatives of the United States by : United States. Congress. House
Download or read book Journal of the House of Representatives of the United States written by United States. Congress. House and published by . This book was released on 2014 with total page 1468 pages. Available in PDF, EPUB and Kindle. Book excerpt: Some vols. include supplemental journals of "such proceedings of the sessions, as, during the time they were depending, were ordered to be kept secret, and respecting which the injunction of secrecy was afterwards taken off by the order of the House."
Download or read book Pharmacology written by Luca Gallelli and published by BoD – Books on Demand. This book was released on 2012-03-14 with total page 735 pages. Available in PDF, EPUB and Kindle. Book excerpt: The history of pharmacology travels together to history of scientific method and the latest frontiers of pharmacology open a new world in the search of drugs. New technologies and continuing progress in the field of pharmacology has also changed radically the way of designing a new drug. In fact, modern drug discovery is based on deep knowledge of the disease and of both cellular and molecular mechanisms involved in its development. The purpose of this book was to give a new idea from the beginning of the pharmacology, starting from pharmacodynamic and reaching the new field of pharmacogenetic and ethnopharmacology.
Book Synopsis Automated Medical Records by : United States. General Accounting Office
Download or read book Automated Medical Records written by United States. General Accounting Office and published by . This book was released on 1993 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Real-World Evidence in Medical Product Development by : Weili He
Download or read book Real-World Evidence in Medical Product Development written by Weili He and published by Springer Nature. This book was released on 2023-05-11 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioners for the uptake of RWE/D. Randomized clinical trials have been the gold standard for the evaluation of efficacy and safety of medical products. However, the cost, duration, practicality, and limited generalizability have incentivized many to look for alternative ways to optimize drug development. This book provides a comprehensive list of topics together to include all aspects with the uptake of RWE/D, including, but not limited to, applications in regulatory and non-regulatory settings, causal inference methodologies, organization and infrastructure considerations, logistic challenges, and practical use cases.
Author :United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions Publisher : ISBN 13 : Total Pages :160 pages Book Rating :4.:/5 (327 download)
Book Synopsis Nomination of Lester M. Crawford by : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Download or read book Nomination of Lester M. Crawford written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2005 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Springer Handbook of Internet of Things by : Sébastien Ziegler
Download or read book Springer Handbook of Internet of Things written by Sébastien Ziegler and published by Springer Nature. This book was released on with total page 998 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Federal Register written by and published by . This book was released on 2012-06 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Benefit-Risk Assessment Methods in Medical Product Development by : Qi Jiang
Download or read book Benefit-Risk Assessment Methods in Medical Product Development written by Qi Jiang and published by CRC Press. This book was released on 2017-12-19 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.
Book Synopsis OECD Health Policy Studies Ready for the Next Crisis? Investing in Health System Resilience by : OECD
Download or read book OECD Health Policy Studies Ready for the Next Crisis? Investing in Health System Resilience written by OECD and published by OECD Publishing. This book was released on 2023-02-23 with total page 475 pages. Available in PDF, EPUB and Kindle. Book excerpt: The COVID-19 pandemic had massive consequences for societies and health systems across the OECD and beyond. Health systems were not resilient enough. Resilient health systems plan and are ready for shocks, such as pandemics, economic crises or the effects of climate change.
