Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making
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Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1999-07-27
Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-07-27 with Medical categories.
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.
Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making
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Author :
language : en
Publisher:
Release Date : 1999
Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999 with Clinical trials categories.
Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1999-08-27
Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-08-27 with Medical categories.
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.
Sharing Clinical Trial Data
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2015-04-20
Sharing Clinical Trial Data written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-20 with Medical categories.
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.
Clinical Research Informatics
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Author : Rachel L. Richesson
language : en
Publisher: Springer
Release Date : 2019-02-07
Clinical Research Informatics written by Rachel L. Richesson and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-02-07 with Medical categories.
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.
Clinical Research Informatics
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Author : Rachel Richesson
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-02-10
Clinical Research Informatics written by Rachel Richesson and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-02-10 with Medical categories.
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.
Ethical And Scientific Issues In Studying The Safety Of Approved Drugs
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-07-30
Ethical And Scientific Issues In Studying The Safety Of Approved Drugs written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-07-30 with Medical categories.
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.
Encyclopedia Of Biopharmaceutical Statistics Four Volume Set
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2018-09-03
Encyclopedia Of Biopharmaceutical Statistics Four Volume Set written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-03 with Medical categories.
Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.
Embc 2004
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Author : IEEE Engineering in Medicine and Biology Society. Conference
language : en
Publisher:
Release Date : 2004
Embc 2004 written by IEEE Engineering in Medicine and Biology Society. Conference and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Biomedical engineering categories.
Management Of Data In Clinical Trials
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Author : Eleanor McFadden
language : en
Publisher: John Wiley & Sons
Release Date : 2007-12-14
Management Of Data In Clinical Trials written by Eleanor McFadden and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-12-14 with Mathematics categories.
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.