Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making PDF full book. Access full book title Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making by Institute of Medicine. Download full books in PDF and EPUB format.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309065941
Category : Medical
Languages : en
Pages : 89
Get Book Here
Book Description
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
Publisher: National Academies Press
ISBN: 0309065941
Category : Medical
Languages : en
Pages : 89
Get Book Here
Book Description
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
Publisher: National Academies Press
ISBN: 0309086779
Category : Medical
Languages : en
Pages : 89
Get Book Here
Book Description
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:
Publisher:
ISBN:
Category : Clinical trials
Languages : en
Pages : 0
Get Book Here
Book Description
Author: Rachel Richesson
Publisher: Springer Science & Business Media
ISBN: 1848824483
Category : Medical
Languages : en
Pages : 415
Get Book Here
Book Description
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: Rachel L. Richesson
Publisher: Springer Nature
ISBN: 3031271734
Category : Medical
Languages : en
Pages : 519
Get Book Here
Book Description
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 informatics professional 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 informatics professional looking to learn and expand their understanding of this fast-moving and increasingly important discipline.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236
Get Book Here
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: F. Lau
Publisher: IOS Press
ISBN: 1614999511
Category : Medical
Languages : en
Pages : 570
Get Book Here
Book Description
Information technology is revolutionizing healthcare, and the uptake of health information technologies is rising, but scientific research and industrial and governmental support will be needed if these technologies are to be implemented effectively to build capacity at regional, national and global levels. This book, "Improving Usability, Safety and Patient Outcomes with Health Information Technology", presents papers from the Information Technology and Communications in Health conference, ITCH 2019, held in Victoria, Canada from 14 to 17 February 2019. The conference takes a multi-perspective view of what is needed to move technology forward to sustained and widespread use by transitioning research findings and approaches into practice. Topics range from improvements in usability and training and the need for new and improved designs for information systems, user interfaces and interoperable solutions, to governmental policy, mandates, initiatives and the need for regulation. The knowledge and insights gained from the ITCH 2019 conference will surely stimulate fruitful discussions and collaboration to bridge research and practice and improve usability, safety and patient outcomes, and the book will be of interest to all those associated with the development, implementation and delivery of health IT solutions.
Author: Meredith Zozus
Publisher: CRC Press
ISBN: 1351647733
Category : Computers
Languages : en
Pages : 255
Get Book Here
Book Description
The Data Book: Collection and Management of Research Data is the first practical book written for researchers and research team members covering how to collect and manage data for research. The book covers basic types of data and fundamentals of how data grow, move and change over time. Focusing on pre-publication data collection and handling, the text illustrates use of these key concepts to match data collection and management methods to a particular study, in essence, making good decisions about data. The first section of the book defines data, introduces fundamental types of data that bear on methodology to collect and manage them, and covers data management planning and research reproducibility. The second section covers basic principles of and options for data collection and processing emphasizing error resistance and traceability. The third section focuses on managing the data collection and processing stages of research such that quality is consistent and ultimately capable of supporting conclusions drawn from data. The final section of the book covers principles of data security, sharing, and archival. This book will help graduate students and researchers systematically identify and implement appropriate data collection and handling methods.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309082552
Category : Medical
Languages : en
Pages : 112
Get Book Here
Book Description
The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the key stakeholders in the field. The agenda, and hence the summaries of the presentations that were made in the workshop and which are presented in this summary report, was organized to first examine the nature of innovation in the field and the social and economic infrastructure that supports such innovation. The next objective was to identify and discuss the greatest unmet clinical needs, with a futuristic view of technologies that might meet those needs. And finally, consideration was given to the barriers to the application of new technologies to meet clinical needs.
Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 135111025X
Category : Medical
Languages : en
Pages : 4031
Get Book Here
Book Description
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.
