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Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309316324 Category : Medical Languages : en Pages : 236
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: 0309316324 Category : Medical Languages : en Pages : 236
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: David Eugene Wilkins Publisher: University of Oklahoma Press ISBN: 9780806133959 Category : Social Science Languages : en Pages : 340
Book Description
In the early 1970s, the federal government began recognizing self-determination for American Indian nations. As sovereign entities, Indian nations have been able to establish policies concerning health care, education, religious freedom, law enforcement, gaming, and taxation. David E. Wilkins and K. Tsianina Lomawaima discuss how the political rights and sovereign status of Indian nations have variously been respected, ignored, terminated, and unilaterally modified by federal lawmakers as a result of the ambivalent political and legal status of tribes under western law.
Author: Kevin Davies Publisher: Simon and Schuster ISBN: 1416570187 Category : Science Languages : en Pages : 354
Book Description
In this essential guide to the brave new future, Dr. Kevin Davies, author of Cracking the Genome, reveals the masterful ingenuity that transformed the process of decoding DNA and vividly brings the extraordinary drama of the grand scientific achievement to life. In 2000, President Bill Clinton signaled the completion of the Human Genome Project at a cost in excess of $2 billion. A decade later, the price for any of us to order our own personal genome sequence—a comprehensive map of the 3 billion letters in our DNA—had already dropped to just $1,000. Dozens of men and women—scientists, entrepreneurs, celebrities, and patients—have already been sequenced, pioneering a bold new era of personalized genomic medicine. The $1,000 genome has long been considered the tipping point that would open the floodgates to this revolution. How has this astonishing achievement been accomplished? To research the story of this unfolding revolution, critically acclaimed science writer Kevin Davies traveled to the leading centers and interviewed the entrepreneurs and pioneers in the race to achieve the $1,000 genome. Davies also profiles the future of genomic medicine and thoughtfully explores the many pressing issues raised by the tidal wave of personal genetic information.
Author: Khaled El Emam Publisher: "O'Reilly Media, Inc." ISBN: 1449363032 Category : Computers Languages : en Pages : 252
Book Description
Updated as of August 2014, this practical book will demonstrate proven methods for anonymizing health data to help your organization share meaningful datasets, without exposing patient identity. Leading experts Khaled El Emam and Luk Arbuckle walk you through a risk-based methodology, using case studies from their efforts to de-identify hundreds of datasets. Clinical data is valuable for research and other types of analytics, but making it anonymous without compromising data quality is tricky. This book demonstrates techniques for handling different data types, based on the authors’ experiences with a maternal-child registry, inpatient discharge abstracts, health insurance claims, electronic medical record databases, and the World Trade Center disaster registry, among others. Understand different methods for working with cross-sectional and longitudinal datasets Assess the risk of adversaries who attempt to re-identify patients in anonymized datasets Reduce the size and complexity of massive datasets without losing key information or jeopardizing privacy Use methods to anonymize unstructured free-form text data Minimize the risks inherent in geospatial data, without omitting critical location-based health information Look at ways to anonymize coding information in health data Learn the challenge of anonymously linking related datasets
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309268745 Category : Medical Languages : en Pages : 157
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: Joram Piatigorsky Publisher: Harvard University Press ISBN: 9780674023413 Category : Science Languages : en Pages : 434
Book Description
In Gene Sharing and Evolution Piatigorsky explores the generality and implications of gene sharing throughout evolution and argues that most if not all proteins perform a variety of functions in the same and in different species, and that this is a fundamental necessity for evolution.
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 030937085X Category : Science Languages : en Pages : 115
Book Description
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: Geraldine A. Van der Auwera Publisher: O'Reilly Media ISBN: 1491975164 Category : Science Languages : en Pages : 496
Book Description
Data in the genomics field is booming. In just a few years, organizations such as the National Institutes of Health (NIH) will host 50+ petabytesâ??or over 50 million gigabytesâ??of genomic data, and theyâ??re turning to cloud infrastructure to make that data available to the research community. How do you adapt analysis tools and protocols to access and analyze that volume of data in the cloud? With this practical book, researchers will learn how to work with genomics algorithms using open source tools including the Genome Analysis Toolkit (GATK), Docker, WDL, and Terra. Geraldine Van der Auwera, longtime custodian of the GATK user community, and Brian Oâ??Connor of the UC Santa Cruz Genomics Institute, guide you through the process. Youâ??ll learn by working with real data and genomics algorithms from the field. This book covers: Essential genomics and computing technology background Basic cloud computing operations Getting started with GATK, plus three major GATK Best Practices pipelines Automating analysis with scripted workflows using WDL and Cromwell Scaling up workflow execution in the cloud, including parallelization and cost optimization Interactive analysis in the cloud using Jupyter notebooks Secure collaboration and computational reproducibility using Terra
Author: James Shreeve Publisher: Ballantine Books ISBN: 0307417069 Category : Science Languages : en Pages : 418
Book Description
The long-awaited story of the science, the business, the politics, the intrigue behind the scenes of the most ferocious competition in the history of modern science—the race to map the human genome. On May 10, 1998, biologist Craig Venter, director of the Institute for Genomic Research, announced that he was forming a private company that within three years would unravel the complete genetic code of human life—seven years before the projected finish of the U.S. government’s Human Genome Project. Venter hoped that by decoding the genome ahead of schedule, he would speed up the pace of biomedical research and save the lives of thousands of people. He also hoped to become very famous and very rich. Calling his company Celera (from the Latin for “speed”), he assembled a small group of scientists in an empty building in Rockville, Maryland, and set to work. At the same time, the leaders of the government program, under the direction of Francis Collins, head of the National Human Genome Research Institute at the National Institutes of Health, began to mobilize an unexpectedly unified effort to beat Venter to the prize—knowledge that had the potential to revolutionize medicine and society. The stage was set for one of the most thrilling—and important—dramas in the history of science. The Genome War is the definitive account of that drama—the race for the greatest prize biology has had to offer, told by a writer with exclusive access to Venter’s operation from start to finish. It is also the story of how one man’s ambition created a scientific Camelot where, for a moment, it seemed that the competing interests of pure science and commercial profit might be gloriously reconciled—and the national repercussions that resulted when that dream went awry.
Author: Raúl Rabadán Publisher: Cambridge University Press ISBN: 1108753396 Category : Science Languages : en Pages : 521
Book Description
Biology has entered the age of Big Data. The technical revolution has transformed the field, and extracting meaningful information from large biological data sets is now a central methodological challenge. Algebraic topology is a well-established branch of pure mathematics that studies qualitative descriptors of the shape of geometric objects. It aims to reduce questions to a comparison of algebraic invariants, such as numbers, which are typically easier to solve. Topological data analysis is a rapidly-developing subfield that leverages the tools of algebraic topology to provide robust multiscale analysis of data sets. This book introduces the central ideas and techniques of topological data analysis and its specific applications to biology, including the evolution of viruses, bacteria and humans, genomics of cancer and single cell characterization of developmental processes. Bridging two disciplines, the book is for researchers and graduate students in genomics and evolutionary biology alongside mathematicians interested in applied topology.
Author: Institute of Medicine
Author: Institute of Medicine
Author: David Eugene Wilkins
Author: Kevin Davies
Author: Khaled El Emam
Author: Institute of Medicine
Author: Joram Piatigorsky
Author: National Academies of Sciences, Engineering, and Medicine
Author: Geraldine A. Van der Auwera
Author: James Shreeve
Author: Raúl Rabadán