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Author: Kalman Dubov
Publisher: Kalman Dubov
ISBN:
Category : Medical
Languages : en
Pages :
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Book Description
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 However, if the DSMB stops a study, the IRB must be notified immediately so that the study's approval can be withdrawn.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.
Author: Kalman Dubov
Publisher: Kalman Dubov
ISBN:
Category : Medical
Languages : en
Pages :
Get Book Here
Book Description
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.
Author: Kalman Dubov
Publisher: Kalman Dubov
ISBN:
Category : Medical
Languages : en
Pages :
Get Book Here
Book Description
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.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240063129
Category : Medical
Languages : en
Pages : 134
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Book Description
Author: Jay Herson
Publisher: CRC Press
ISBN: 1498784127
Category : Mathematics
Languages : en
Pages : 266
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236
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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: U.S. Nuclear Regulatory Commission
Publisher:
ISBN:
Category : Nuclear energy
Languages : en
Pages : 688
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Book Description
Author: A. T. Panter
Publisher: Routledge
ISBN: 1136888721
Category : Psychology
Languages : en
Pages : 508
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Book Description
This comprehensive Handbook is the first to provide a practical, interdisciplinary review of ethical issues as they relate to quantitative methodology including how to present evidence for reliability and validity, what comprises an adequate tested population, and what constitutes scientific knowledge for eliminating biases. The book uses an ethical framework that emphasizes the human cost of quantitative decision making to help researchers understand the specific implications of their choices. The order of the Handbook chapters parallels the chronology of the research process: determining the research design and data collection; data analysis; and communicating findings. Each chapter: Explores the ethics of a particular topic Identifies prevailing methodological issues Reviews strategies and approaches for handling such issues and their ethical implications Provides one or more case examples Outlines plausible approaches to the issue including best-practice solutions. Part 1 presents ethical frameworks that cross-cut design, analysis, and modeling in the behavioral sciences. Part 2 focuses on ideas for disseminating ethical training in statistics courses. Part 3 considers the ethical aspects of selecting measurement instruments and sample size planning and explores issues related to high stakes testing, the defensibility of experimental vs. quasi-experimental research designs, and ethics in program evaluation. Decision points that shape a researchers’ approach to data analysis are examined in Part 4 – when and why analysts need to account for how the sample was selected, how to evaluate tradeoffs of hypothesis-testing vs. estimation, and how to handle missing data. Ethical issues that arise when using techniques such as factor analysis or multilevel modeling and when making causal inferences are also explored. The book concludes with ethical aspects of reporting meta-analyses, of cross-disciplinary statistical reform, and of the publication process. This Handbook appeals to researchers and practitioners in psychology, human development, family studies, health, education, sociology, social work, political science, and business/marketing. This book is also a valuable supplement for quantitative methods courses required of all graduate students in these fields.
Author: Simon Elias Bibri
Publisher: Springer Nature
ISBN: 3031523032
Category :
Languages : en
Pages : 286
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Book Description
Author: Michael J. McGrath
Publisher: Apress
ISBN: 1430260149
Category : Computers
Languages : en
Pages : 321
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Book Description
Sensor Technologies: Healthcare, Wellness and Environmental Applications explores the key aspects of sensor technologies, covering wired, wireless, and discrete sensors for the specific application domains of healthcare, wellness and environmental sensing. It discusses the social, regulatory, and design considerations specific to these domains. The book provides an application-based approach using real-world examples to illustrate the application of sensor technologies in a practical and experiential manner. The book guides the reader from the formulation of the research question, through the design and validation process, to the deployment and management phase of sensor applications. The processes and examples used in the book are primarily based on research carried out by Intel or joint academic research programs. “Sensor Technologies: Healthcare, Wellness and Environmental Applications provides an extensive overview of sensing technologies and their applications in healthcare, wellness, and environmental monitoring. From sensor hardware to system applications and case studies, this book gives readers an in-depth understanding of the technologies and how they can be applied. I would highly recommend it to students or researchers who are interested in wireless sensing technologies and the associated applications.” Dr. Benny Lo Lecturer, The Hamlyn Centre, Imperial College of London “This timely addition to the literature on sensors covers the broad complexity of sensing, sensor types, and the vast range of existing and emerging applications in a very clearly written and accessible manner. It is particularly good at capturing the exciting possibilities that will occur as sensor networks merge with cloud-based ‘big data’ analytics to provide a host of new applications that will impact directly on the individual in ways we cannot fully predict at present. It really brings this home through the use of carefully chosen case studies that bring the overwhelming concept of 'big data' down to the personal level of individual life and health.” Dermot Diamond Director, National Centre for Sensor Research, Principal Investigator, CLARITY Centre for Sensor Web Technologies, Dublin City University "Sensor Technologies: Healthcare, Wellness and Environmental Applications takes the reader on an end-to-end journey of sensor technologies, covering the fundamentals from an engineering perspective, introducing how the data gleaned can be both processed and visualized, in addition to offering exemplar case studies in a number of application domains. It is a must-read for those studying any undergraduate course that involves sensor technologies. It also provides a thorough foundation for those involved in the research and development of applied sensor systems. I highly recommend it to any engineer who wishes to broaden their knowledge in this area!" Chris Nugent Professor of Biomedical Engineering, University of Ulster
Author: C.A. Raji
Publisher: IOS Press
ISBN: 1643685015
Category : Medical
Languages : en
Pages : 768
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Book Description
It is almost 120 years since Alzheimer’s disease (AD) was first reported, and the concept of managing some of the modifiable risk factors associated with the disease has been present from the outset. Intervening to manage risk factors as a way of tackling AD is not new, but optimizing brain health as a way of minimizing risk and maximizing the potential benefits of revolutionary new treatments for AD is becoming increasingly important. This book, the Handbook of Intervention and Alzheimer’s Disease, presents 47 papers exploring factors which may either inspire or inform future treatment and clinical trials. While novel interventions such as anti-amyloid immunotherapy present great opportunities, they may also increase the risk of brain bleeds and edema, which in turn may lead to adverse clinical outcomes. Such adverse outcomes are demonstrably more likely to occur in persons with poor brain health, so improved management of the risk factors which make up the AD preventome will also minimize the risks associated with such novel therapies. The papers in this volume can therefore be thought of as offering insight into those factors that can optimize brain health or providing key insights into interventions which may achieve such outcomes. Together with its companion volume on prevention, the book provides a comprehensive overview of strategies for tackling Alzheimer’s disease, and will be of interest to all those working in the field. Cover illustration: Improved hypoperfusion (resolving blue colors) on ASL MRI Z-score maps superimposed on structural MRI scans at baseline and one year in a PET amyloid-positive research participant with cognitive complaints undergoing one year of multi-domain personalized brain health interventions (vascular disease management, dietary optimization, sustained physical activity etc.). Permission to use this figure was granted both by the study P.I. Dr. David Merrill, MD, PhD, of the Pacific Neuroscience Institute and the research participant.
