Read Books Online and Download eBooks, EPub, PDF, Mobi, Kindle, Text Full Free.
Data And Safety Monitoring Boards In Nih Clinical Trials Meeting Guidance But Facing Some Issues
Download Data And Safety Monitoring Boards In Nih Clinical Trials Meeting Guidance But Facing Some Issues full books in PDF, epub, and Kindle. Read online Data And Safety Monitoring Boards In Nih Clinical Trials Meeting Guidance But Facing Some Issues ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
Book Synopsis Data and Safety Monitoring Boards in Nih Clinical Trials Meeting Guidance, But Facing Some Issues. by : CreateSpace Independent Publishing Platform
Download or read book Data and Safety Monitoring Boards in Nih Clinical Trials Meeting Guidance, But Facing Some Issues. written by CreateSpace Independent Publishing Platform and published by Createspace Independent Publishing Platform. This book was released on 2018-07-11 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data and safety monitoring boards in NIH clinical trials meeting guidance, but facing some issues.
Author :United States. Department of Health and Human Services. Office of Inspector General Publisher : ISBN 13 : Total Pages :17 pages Book Rating :4.:/5 (953 download)
Book Synopsis Data and Safety Monitoring Boards in NIH Clinical Trials Meeting Guidance, But Facing Some Issues by : United States. Department of Health and Human Services. Office of Inspector General
Download or read book Data and Safety Monitoring Boards in NIH Clinical Trials Meeting Guidance, But Facing Some Issues written by United States. Department of Health and Human Services. Office of Inspector General and published by . This book was released on 2013 with total page 17 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Data Safety Monitoring Board - Module A by : Kalman Dubov
Download or read book The Data Safety Monitoring Board - Module A written by Kalman Dubov and published by Kalman Dubov. This book was released on 2022-01-09 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: A key function during clinical trials is the Data Safety Monitoring Board (DSMB). The board is composed of several experts who review the investigational trial and receive unblinded data from the clinical investigator as well as the study sponsor. The unblinded data can be reviewed to determine if an adverse event is relevant to the study. The DSMB has the authority, if necessary, to stop the study at an appropriate juncture. There are two modules that present the concept of the DSMB, with specific detail related to investigational studies where the establishment of the DSMB is warranted. The key factor of reviewing an adverse event at an investigational site allows the DSMB to assess the risks in the study. The DSMB is established by charter detailing the scope of the board's authority, the composition of its members, how often the board will meet, and the types of meetings the board will conduct. In addition, the board must be grounded in the design types of studies so they are appreciative of the way the investigational trial will be conducted. Module B continues with different phases of clinical trials, with a key discussion of the study types where a DSMB is mandated. the board must also be aware of the FDA's recall system since it may affect the ongoing investigational trial. The review continues with the types of meetings undertaken by the DSMB, to include information obtained from the Department of Defense Research Monitor who may be a DSMB voting member. The module then reviews the specific actions the DSMB may take during the study, with practical recommendations the board should consider during its meetings. A critical aspect of the board's responsibility is its communication with the institutional review board (IRB (whether a specific IRB or a multiplicity of different IRBs. While the IRB does not receive unblinded data, the DSMB only receives unblinded data, so that communication with the IRB, by necessity, is restricted to data that can be shared with the IRB. However, if the DSMB stops a study, the IRB must be notified immediately so that the study's approval can be withdrawn. The scope of the duties of the DSMB is to provide the members with key data so as to protect the study subjects and ensure the trial is conducted in an optimal manner.
Book Synopsis The Data Safety Monitoring Board - Module B by : Kalman Dubov
Download or read book The Data Safety Monitoring Board - Module B written by Kalman Dubov and published by Kalman Dubov. This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: A key function during clinical trials is the Data Safety Monitoring Board (DSMB). The board is composed of several experts who review the investigational trial and receive unblinded data from the clinical investigator as well as the study sponsor. The unblinded data can be reviewed to determine if an adverse event is relevant to the study. The DSMB has the authority, if necessary, to stop the study at an appropriate juncture. There are two modules that present the concept of the DSMB, with specific detail related to investigational studies where the establishment of the DSMB is warranted. The key factor of reviewing an adverse event at an investigational site allows the DSMB to assess the risks in the study. The DSMB is established by charter detailing the scope of the board's authority, the composition of its members, how often the board will meet, and the types of meetings the board will conduct. In addition, the board must be grounded in the design types of studies so they are appreciative of the way the investigational trial will be conducted. Module B continues with different phases of clinical trials, with a key discussion of the study types where a DSMB is mandated. the board must also be aware of the FDA's recall system since it may affect the ongoing investigational trial. The review continues with the types of meetings undertaken by the DSMB, to include information obtained from the Department of Defense Research Monitor who may be a DSMB voting member. The module then reviews the specific actions the DSMB may take during the study, with practical recommendations the board should consider during its meetings. A critical aspect of the board's responsibility is its communication with the institutional review board (IRB (whether a specific IRB or a multiplicity of different IRBs. While the IRB does not receive unblinded data, the DSMB only receives unblinded data, so that communication with the IRB, by necessity, is restricted to data that can be shared with the IRB. However, if the DSMB stops a study, the IRB must be notified immediately so that the study's approval can be withdrawn. The scope of the duties of the DSMB is to provide the members with key data so as to protect the study subjects and ensure the trial is conducted in an optimal manner.
Book Synopsis Data and Safety Monitoring Committees in Clinical Trials by : Jay Herson
Download or read book Data and Safety Monitoring Committees in Clinical Trials written by Jay Herson and published by CRC Press. This book was released on 2009-03-13 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author’s experience in serving on many data monitoring committees (DMCs) and in heading up a contract research organization that provided statistical support to nearly seventy-five DMCs. It explains the difference in DMC operations between the pharmaceutical industry and National Institutes of Health (NIH)-sponsored trials. Leading you through the types of reports for adverse events and lab values, the author presents the statistical requirements of data monitoring committees and gives advice on how statisticians can best interact with physician members of these committees. He also shows how physicians think differently about safety data than statisticians, proving that both views are needed.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Data Monitoring Committees in Clinical Trials by : Susan S. Ellenberg
Download or read book Data Monitoring Committees in Clinical Trials written by Susan S. Ellenberg and published by John Wiley & Sons. This book was released on 2003-01-17 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities. * Provides a practical overview of data monitoring in clinical trials. * Describes the purpose, responsibilities and operation of data monitoring committees. * Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees. * Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees. * Discusses issues pertinent to those working in clinical trials in both the US and Europe. The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.
Book Synopsis Data Monitoring Committees in Clinical Trials by : Susan S. Ellenberg
Download or read book Data Monitoring Committees in Clinical Trials written by Susan S. Ellenberg and published by John Wiley & Sons. This book was released on 2019-01-15 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: The authoritative guide for Data Monitoring Committees—fully revised and updated The number of clinical trials sponsored by government agencies and pharmaceutical companies has grown in recent years, prompting an increased need for interim monitoring of data on safety and efficacy. Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and protecting the credibility and validity of the study. Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition offers practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees, providing a practical overview of the establishment, purpose, and responsibilities of these committees. Examination of topics such as the composition and independence of DMCs, statistical, philosophical and ethical considerations, and determining when a DMC is needed, presents readers with a comprehensive foundational knowledge of clinical trial oversight. Providing recent examples to illustrate DMC principles, this fully-updated guide reflects current developments and practices in clinical trial oversight and offers expanded coverage of emerging issues and challenges in the field. This new second edition covers the most current information on DMC policies, issues in monitoring trials using new designs, and recent trial publications relevant to DMC decision-making. • Presents practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees • Illustrates the types of challenging issues Data Monitoring Committees face in practical situations • Provides updated and expanded coverage of topics including regulatory and funding agency guidelines and trial designs and their associated demands and limitations • Includes a new chapter addressing legal issues that affect DMC members and discusses general litigation concerns relevant to clinical research • Expands treatment of current journal publications addressing DMC issues Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition is a must-have text for anyone engaged in DMC activities as well as trial sponsors, clinical trial researchers, regulatory and bioethics professionals, and those associated with clinical trials in academic, government and industry settings.
Book Synopsis Data Monitoring in Clinical Trials by : David L. DeMets
Download or read book Data Monitoring in Clinical Trials written by David L. DeMets and published by Springer Science & Business Media. This book was released on 2006-06-22 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: From the authors of "Fundamentals of Clinical Trials" which has sold over 15,000 copies world wide since its publication in 1998. No competition yet as the text does not focus on how to do clinical trials but on very specific situations that can be encountered during the process.
Book Synopsis Data and Safety Monitoring Committees in Clinical Trials by : Jay Herson
Download or read book Data and Safety Monitoring Committees in Clinical Trials written by Jay Herson and published by CRC Press. This book was released on 2016-12-19 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.
Book Synopsis Transforming Clinical Research in the United States by : Institute of Medicine
Download or read book Transforming Clinical Research in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-22 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.
Book Synopsis Field Trials of Health Interventions by : Peter G. Smith
Download or read book Field Trials of Health Interventions written by Peter G. Smith and published by . This book was released on 2015 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.
Book Synopsis Principles and Practice of Clinical Trials by : Steven Piantadosi
Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
Book Synopsis Essentials of Clinical Research by : Stephen P. Glasser
Download or read book Essentials of Clinical Research written by Stephen P. Glasser and published by Springer. This book was released on 2014-06-02 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: In its extensively revised and updated Second Edition, this book provides a solid foundation for readers interested in clinical research. Discussion encompasses genetic, pharmacoepidemiologic and implementation research. All chapters have been updated with new information and many new tables have been added to elucidate key points. The book now offers discussion on how to handle missing data when analyzing results, and coverage of Adaptive Designs and Effectiveness Designs and new sections on Comparative Effectiveness Research and Pragmatic Trials. Chapter 6 includes new material on Phase 0 Trials, expanded coverage of Futility Trials, a discussion of Medical Device approval, Off Label Drug use and the role of the FDA in regulating advertising. Additional new information includes the role of pill color and shape in association with the placebo effect and an examination of issues surrounding minority recruitment. The final chapter offers a new section on manuscript preparation along with a discussion of various guidelines being adopted by journals: CONSORT, STROBE, PRISMA, MOOSE and others; and coverage of Conflicts of Interest, Authorship, Coercive Citation, and Disclosures in Industry-Related Associations. Building on the strengths of its predecessor in its comprehensive approach and authoritative advice, the new edition offers more of what has made this book a popular, trusted resource for students and working researchers alike.
Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine
Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Responsible Conduct of Research by : Adil E. Shamoo
Download or read book Responsible Conduct of Research written by Adil E. Shamoo and published by Oxford University Press. This book was released on 2009-02-12 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.
Book Synopsis The Design and Analysis of Sequential Clinical Trials by : John Whitehead
Download or read book The Design and Analysis of Sequential Clinical Trials written by John Whitehead and published by Horwood Publishing Limited. This book was released on 1983 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book details all aspects of sequential clinical trials from preliminary planning, through the monitoring of the trial, to the final analysis of the results.
