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 However, if the DSMB stops a study, the IRB must be notified immediately so that the study's approval can be withdrawn.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 :
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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 : Science
Languages : en
Pages :
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Book Description
Clinical investigations with biologics are commonly complex, requiring detailed knowledge of the regulatory frameworks for both drugs and biologics since the Food & Drug Administration applies the regulations for drugs as well as for biologics for such clinical investigations. The complexity is furthered if the article is a combination biologic-drug or biologic-device. These three modules are designed to assist the sponsor and clinical investigator in conducting professional investigational trials for biologics. The FDA has a specific Center for biologics, with regulations and many guidance documents to assist the industry and investigators in the requirements for such trials. These two modules provide the basics of understanding the regulatory framework and complying with the Agency's requirements. Module A focuses on the Principal Investigator and the responsibilities necessary to comply with FDA requirements during the course of the clinical trial. The module begins with the definition of a biologic, followed by a review of clinical trials, gene transfer studies, the clinical investigator's responsibilities during the trial with regard to documentation, risks, how to respond to the study sponsor, the Data Safety Monitoring Board (DSMB), and the FDA. The module concludes with details regarding the consent form and process, detailing what is necessary to consent a subject into the study. Module B focuses on the study sponsor and the submissions to the FDA for permission to begin the study. The module begins with a review of the protocol sections, together with the electronic Common Technical Document (eCTD), the phases of the clinical investigation, a review of combination products, dual-use technologies, concluding with the FDA audit. These two modules, though comprehensive, can be mastered to the great benefit of the investigational community, and more so, for the patient who will receive an approved biologic that has proven efficacy.
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: Nicholas Goodnight
Publisher: Jones & Bartlett Learning
ISBN: 128419518X
Category : Transportation
Languages : en
Pages : 760
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Book Description
Automotive Engine Performance, published as part of the CDX Master Automotive Technician Series, provides technicians in training with a detailed overview of modern engine technologies and diagnostic strategies. Taking a "strategy-based diagnostic" approach, it helps students master the skills needed to diagnose and resolve customer concerns correctly on the first attempt. Students will gain an understanding of current diagnostic tools and advanced performance systems as they prepare to service the engines of tomorrow.
Author: U.S. Nuclear Regulatory Commission
Publisher:
ISBN:
Category : Nuclear energy
Languages : en
Pages : 688
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Book Description
Author: Jay Herson
Publisher: CRC Press
ISBN: 1351722379
Category : Mathematics
Languages : en
Pages : 179
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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: 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: Charles Chen
Publisher: Springer Nature
ISBN: 9464633042
Category : Technology & Engineering
Languages : en
Pages : 771
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Book Description
This is an open access book. The 3rd International Conference on Digital Economy and Computer Applications (DECA 2023) will be held on September 22–24, 2023 in Shanghai, China. Digital economy is the main economic form after agricultural economy and industrial economy. It takes data resources as the key element, modern information network as the main carrier, and the integration and application of information and communication technology and all-factor digital transformation as the important driving force to promote a new economic form that is more unified in fairness and efficiency. The essence of digital economy is informationization. Informatization is a social and economic process caused by the revolution of production tools, such as computer and Internet, from industrial economy to information economy. The theme of the conference mainly focuses on digital economy and computer applications and other related research fields, aiming to provide an international cooperation and exchange platform for experts and scholars in related research fields and enterprise development personnel to share research results, discuss existing problems and challenges, and explore cutting-edge technologies. We sincerely invite experts and scholars from universities and research institutions at home and abroad, entrepreneurs and other relevant personnel to contribute and participate in the conference. The DECA 2023 is accepting papers for proceeding publication. We accept contributions from those who care about exploring and enhancing the research and innovation in Digital Economy and Computer Applications in the world. The directions of the call for papers are as follows: Internet of Things (IoT), Blockchain Technology, Service-Oriented and Cloud, Industry Track, Deliver the Intelligent Enterprise, Mobile business and Autonomous Computing and other papers in line with the direction of digital economy and computer applications. We welcome submissions from scholars, students, and practitioners across many disciplines that contribute to the study and practice of Digital Economy and Computer Applications.
