Discussion Framework For Clinical Trial Data Sharing PDF Download
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| Author | : Committee on Strategies for Responsible Sharing of Clinical Trial Data |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2014 |
| Genre | : Clinical trials |
| ISBN | : 9780309297790 |
Download Discussion Framework for Clinical Trial Data Sharing Book in PDF, ePub and Kindle
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 | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 304 |
| Release | : 2015-04-20 |
| Genre | : Medical |
| ISBN | : 0309316324 |
Download Sharing Clinical Trial Data Book in PDF, ePub and Kindle
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 | : Pieter Kubben |
| Publisher | : Springer |
| Total Pages | : 219 |
| Release | : 2018-12-21 |
| Genre | : Medical |
| ISBN | : 3319997130 |
Download Fundamentals of Clinical Data Science Book in PDF, ePub and Kindle
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.
| Author | : National Academies of Sciences, Engineering, and Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 102 |
| Release | : 2015-09-18 |
| Genre | : Science |
| ISBN | : 0309378125 |
Download Sharing Research Data to Improve Public Health in Africa Book in PDF, ePub and Kindle
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 | : Agency for Healthcare Research and Quality/AHRQ |
| Publisher | : Government Printing Office |
| Total Pages | : 396 |
| Release | : 2014-04-01 |
| Genre | : Medical |
| ISBN | : 1587634333 |
Download Registries for Evaluating Patient Outcomes Book in PDF, ePub and Kindle
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.
| Author | : National Academies of Sciences, Engineering, and Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 115 |
| Release | : 2016-05-29 |
| Genre | : Science |
| ISBN | : 030937085X |
Download Principles and Obstacles for Sharing Data from Environmental Health Research Book in PDF, ePub and Kindle
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.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 334 |
| Release | : 2009-03-24 |
| Genre | : Computers |
| ISBN | : 0309124999 |
Download Beyond the HIPAA Privacy Rule Book in PDF, ePub and Kindle
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.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 292 |
| Release | : 2012-07-30 |
| Genre | : Medical |
| ISBN | : 0309218160 |
Download Ethical and Scientific Issues in Studying the Safety of Approved Drugs Book in PDF, ePub and Kindle
An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
| Author | : National Academies of Sciences, Engineering, and Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 273 |
| Release | : 2020-11-30 |
| Genre | : Medical |
| ISBN | : 030968224X |
Download Framework for Equitable Allocation of COVID-19 Vaccine Book in PDF, ePub and Kindle
In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national governments and the international community have invested billions of dollars and immense amounts of human resources to develop a safe and effective vaccine in an unprecedented time frame. Vaccination against this novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), offers the possibility of significantly reducing severe morbidity and mortality and transmission when deployed alongside other public health strategies and improved therapies. Health equity is intertwined with the impact of COVID-19 and there are certain populations that are at increased risk of severe illness or death from COVID-19. In the United States and worldwide, the pandemic is having a disproportionate impact on people who are already disadvantaged by virtue of their race and ethnicity, age, health status, residence, occupation, socioeconomic condition, or other contributing factors. Framework for Equitable Allocation of COVID-19 Vaccine offers an overarching framework for vaccine allocation to assist policy makers in the domestic and global health communities. Built on widely accepted foundational principles and recognizing the distinctive characteristics of COVID-19, this report's recommendations address the commitments needed to implement equitable allocation policies for COVID-19 vaccine.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 157 |
| Release | : 2013-06-07 |
| Genre | : Medical |
| ISBN | : 0309268745 |
Download Sharing Clinical Research Data Book in PDF, ePub and Kindle
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.
