Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making

Author : Institute of Medicine,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
Publisher : National Academies Press
Page : 88 pages
File Size : 51,5 Mb
Release : 1999-07-27
Category : Medical
ISBN : 9780309172806

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Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making by Institute of Medicine,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices Pdf

In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.

Author : Anonim
Publisher : Unknown
Page : 0 pages
File Size : 47,6 Mb
Release : 1999
Category : Clinical trials
ISBN : OCLC:896666416

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Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making by Anonim Pdf

Author : Institute of Medicine,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
Publisher : National Academies Press
Page : 89 pages
File Size : 49,7 Mb
Release : 1999-08-27
Category : Medical
ISBN : 9780309065948

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Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making by Institute of Medicine,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices Pdf

In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher : National Academies Press
Page : 304 pages
File Size : 40,9 Mb
Release : 2015-04-20
Category : Medical
ISBN : 9780309316323

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Sharing Clinical Trial Data by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Pdf

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,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Publisher : National Academies Press
Page : 292 pages
File Size : 55,6 Mb
Release : 2012-07-30
Category : Medical
ISBN : 9780309218160

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Ethical and Scientific Issues in Studying the Safety of Approved Drugs by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs Pdf

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 : Rachel L. Richesson,James E. Andrews
Publisher : Springer
Page : 504 pages
File Size : 52,9 Mb
Release : 2019-02-07
Category : Medical
ISBN : 9783319987798

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Clinical Research Informatics by Rachel L. Richesson,James E. Andrews Pdf

This extensively revised new edition comprehensively reviews the rise of clinical research informatics (CRI). It enables the reader to develop a thorough understanding of how CRI has developed and the evolving challenges facing the biomedical informatician in the modern clinical research environment. Emphasis is placed on the changing role of the consumer, and the need to merge clinical care delivery and research as part of a changing paradigm in global healthcare delivery. Clinical Research Informatics presents a detailed review of using informatics in the continually evolving clinical research environment. It represents a valuable textbook reference for all students and practising healthcare informaticians looking to learn and expand their understanding of this fast-moving and increasingly important discipline.

Author : Rachel Richesson,James E. Andrews
Publisher : Springer Science & Business Media
Page : 415 pages
File Size : 46,6 Mb
Release : 2012-02-10
Category : Medical
ISBN : 9781848824485

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Clinical Research Informatics by Rachel Richesson,James E. Andrews Pdf

The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings.

Author : Institute of Medicine,Board on Health Care Services,Committee on Standards for Systematic Reviews of Comparative Effectiveness Research
Publisher : National Academies Press
Page : 267 pages
File Size : 54,6 Mb
Release : 2011-07-20
Category : Medical
ISBN : 9780309164252

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Finding What Works in Health Care by Institute of Medicine,Board on Health Care Services,Committee on Standards for Systematic Reviews of Comparative Effectiveness Research Pdf

Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
Page : 396 pages
File Size : 47,9 Mb
Release : 2014-04-01
Category : Medical
ISBN : 9781587634338

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Registries for Evaluating Patient Outcomes by Agency for Healthcare Research and Quality/AHRQ Pdf

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 : IEEE Engineering in Medicine and Biology Society. Conference
Publisher : Unknown
Page : 902 pages
File Size : 55,5 Mb
Release : 2004
Category : Biomedical engineering
ISBN : PSU:000054732438

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EMBC 2004 by IEEE Engineering in Medicine and Biology Society. Conference Pdf

Author : National Research Council,Institute of Medicine,Food and Nutrition Board,Board on Agriculture,Committee on Drug Use in Food Animals,Panel on Animal Health, Food Safety, and Public Health
Publisher : National Academies Press
Page : 276 pages
File Size : 45,6 Mb
Release : 1999-01-12
Category : Medical
ISBN : 9780309175777

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The Use of Drugs in Food Animals by National Research Council,Institute of Medicine,Food and Nutrition Board,Board on Agriculture,Committee on Drug Use in Food Animals,Panel on Animal Health, Food Safety, and Public Health Pdf

The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.

Author : Jack E. Olson
Publisher : Elsevier
Page : 300 pages
File Size : 49,7 Mb
Release : 2003-01-09
Category : Computers
ISBN : 9780080503691

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Data Quality by Jack E. Olson Pdf

Data Quality: The Accuracy Dimension is about assessing the quality of corporate data and improving its accuracy using the data profiling method. Corporate data is increasingly important as companies continue to find new ways to use it. Likewise, improving the accuracy of data in information systems is fast becoming a major goal as companies realize how much it affects their bottom line. Data profiling is a new technology that supports and enhances the accuracy of databases throughout major IT shops. Jack Olson explains data profiling and shows how it fits into the larger picture of data quality. * Provides an accessible, enjoyable introduction to the subject of data accuracy, peppered with real-world anecdotes. * Provides a framework for data profiling with a discussion of analytical tools appropriate for assessing data accuracy. * Is written by one of the original developers of data profiling technology. * Is a must-read for any data management staff, IT management staff, and CIOs of companies with data assets.

Author : Eleanor McFadden
Publisher : John Wiley & Sons
Page : 206 pages
File Size : 44,9 Mb
Release : 2007-12-14
Category : Mathematics
ISBN : 9780470181270

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Management of Data in Clinical Trials by Eleanor McFadden Pdf

A valuable new edition of the trusted, practical guide to managing data in clinical trials Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided. While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements. Newly featured topics include: The growing availability of "off-the-shelf" solutions for clinical trials Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry The increasing use of the Internet in the collection of data and management of trials Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines Development of Standard Operating Procedures for the conduct of clinical trials Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.

Author : Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule
Publisher : National Academies Press
Page : 334 pages
File Size : 54,6 Mb
Release : 2009-03-24
Category : Computers
ISBN : 9780309124997

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Beyond the HIPAA Privacy Rule by Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule Pdf

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 : Valérie Junod
Publisher : Unknown
Page : 594 pages
File Size : 44,9 Mb
Release : 2005
Category : Drugs
ISBN : STANFORD:36105063800606

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Clinical Drug Trials by Valérie Junod Pdf