The Data Safety Monitoring Board Module A
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The Data Safety Monitoring Board Module A
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Author : Kalman Dubov
language : en
Publisher: Kalman Dubov
Release Date : 2022-01-09
The Data Safety Monitoring Board Module A written by Kalman Dubov and has been published by Kalman Dubov this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-09 with Medical categories.
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.
The Data Safety Monitoring Board Module B
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Author : Kalman Dubov
language : en
Publisher: Kalman Dubov
Release Date :
The Data Safety Monitoring Board Module B written by Kalman Dubov and has been published by Kalman Dubov this book supported file pdf, txt, epub, kindle and other format this book has been release on with Medical categories.
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.
Sponsor Clinical Investigator Training Module A Biologics
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Author : Kalman Dubov
language : en
Publisher: Kalman Dubov
Release Date : 2022-01-09
Sponsor Clinical Investigator Training Module A Biologics written by Kalman Dubov and has been published by Kalman Dubov this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-09 with Science categories.
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.
Sponsor Clinical Investigator Training Module B Biologics
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Author : Kalman Dubov
language : en
Publisher: Kalman Dubov
Release Date :
Sponsor Clinical Investigator Training Module B Biologics written by Kalman Dubov and has been published by Kalman Dubov this book supported file pdf, txt, epub, kindle and other format this book has been release on with Science categories.
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.
Who Consolidated Guidelines On Tuberculosis Module 4
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2020-06-15
Who Consolidated Guidelines On Tuberculosis Module 4 written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-15 with Medical categories.
BACKGROUND: Tuberculosis (TB) strains with drug resistance (DR-TB) are more difficult to treat than drug-susceptible ones, and threaten global progress towards the targets set by the End TB Strategy of the World Health Organization (WHO). WHO estimates that about half a million cases of multi-drug or rifampicin resistant (MDR/RR-TB) are estimated to occur each year. However, only one third were estimated to have accessed effective treatment and of those, just over half had a successful treatment outcome. Therefore, there is a pressing need for evidence-based policy recommendations on the treatment and care of patients with DR-TB, based on the most recent and comprehensive evidence available. In this regard, the WHO Consolidated Guidelines on Tuberculosis, Module 4: Treatment - Drug-Resistant Tuberculosis Treatment fulfills the mandate of WHO to inform health care professionals in Member States on how to improve treatment and care for patients with DR-TB. The 2020 recommendations on drug resistant TB treatment are contained in the second module to be released under the rubric of WHO Consolidated Guidelines on Tuberculosis (Module 4: Treatment). The WHO Consolidated Guidelines on Tuberculosis will group all TB recommendations in one document and will be complemented by matching modules of a consolidated operational handbook. The operational handbook will provide practical advice on how to put in place the recommendations at the scale needed to achieve national and global impact. OVERVIEW: Between 2011 and 2019, WHO has developed and issued evidence-based policy recommendations on the treatment and care of patients with DR-TB. These policy recommendations have been presented in several WHO documents and their associated annexes, including the WHO Consolidated Guidelines on Drug Resistant Tuberculosis Treatment, issued by WHO in March 2019. The policy recommendations in each of these guidelines have been developed by WHO-convened Guideline Development Groups, using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to summarize the evidence, and formulate policy recommendations and accompanying remarks. The present WHO Consolidated Guidelines on Tuberculosis, Module 4: Treatment - Drug-Resistant Tuberculosis Treatment includes a comprehensive set of WHO recommendations for the treatment and care of DR-TB. The document includes two new recommendations, one on the composition of shorter regimens and one on the use of the BPaL regimen (i.e. bedaquiline, pretomanid and linezolid). In addition, the consolidated guidelines include existing recommendations on treatment regimens for isoniazid-resistant TB and MDR/RR-TB, including longer regimens, culture monitoring of patients on treatment, the timing of antiretroviral therapy (ART) in MDR/RR-TB patients infected with the human immunodeficiency virus (HIV), the use of surgery for patients receiving MDR-TB treatment, and optimal models of patient support and care. The guidelines are to be used primarily in national TB programmes, or their equivalents in Ministries of Health, and for other policy-makers and technical organizations working on TB and infectious diseases in public and private sectors and in the community.
Good Informatics Practices Gip Module Data Management
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Author : Robert Barr
language : en
Publisher: HIMSS
Release Date :
Good Informatics Practices Gip Module Data Management written by Robert Barr and has been published by HIMSS this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.
Fundamentals Of Biologicals Regulation
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Author : Rebecca Sheets
language : en
Publisher: Academic Press
Release Date : 2017-12-13
Fundamentals Of Biologicals Regulation written by Rebecca Sheets and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-12-13 with Medical categories.
Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals. Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products
The Quintessence Of Basic And Clinical Research And Scientific Publishing
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Author : Gowraganahalli Jagadeesh
language : en
Publisher: Springer Nature
Release Date : 2023-11-01
The Quintessence Of Basic And Clinical Research And Scientific Publishing written by Gowraganahalli Jagadeesh and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-01 with Medical categories.
The book, intended for biomedical researchers, attempts to foster a comprehensive understanding of the elements that impact scientific research, such as clinical trial design, communication, and publication methods. It introduces the process of idea generation and creative/critical thinking, leading to the development of key concepts that coalesce into theoretical constructs and working hypotheses. The book systematically delineates research phases associated with a bench-to-bedside translational approach, providing the full depth and breadth of drug discovery and development: design, synthesis, and optimization of drug candidates interacting with targets linked to diseases, as well as clinical trial design to acquire substantial evidence of efficacy and safety for candidate drugs in the target patient population. New and evolving topics such as artificial intelligence, machine and deep learning, drug repurposing approaches, and bioinformatics, are incorporated into the text as these features are becoming integrated into drug research and development. Additionally, it covers publication strategies, including literature search, manuscript preparation, data presentation, relevant discussion, editorial processes, elements of peer review, and bibliometrics. Finally, the book addresses grantsmanship, key strategies for building effective networks, mentorships, maintaining research integrity, and forging career advancement opportunities, including entrepreneurship.
Dictionary For Clinical Trials
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Author : Simon Day
language : en
Publisher: John Wiley & Sons
Release Date : 2007-04-30
Dictionary For Clinical Trials written by Simon Day 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 2007-04-30 with Medical categories.
As a result of the expansion in the area of pharmaceutical medicine there is an ever-increasing need for educational resources. The Dictionary of Clinical Trials, Second Edition comprehensively explains the 3000 words and short phrases commonly used when designing, running, analysing and reporting clinical trials. This book is a quick, pocket reference tool to understand the common and less well-used terms within the discipline of clinical trials, and provides an alternative to the textbooks available. Terms are heavily cross-referenced, which helps the reader to understand how terms fit into the broad picture of clinical trials. Wide ranging, brief, pragmatic explanations of clinical trial terminology Scope includes medical, statistical, epidemiological, ethical, regulatory and data management terminology Thoroughly revised and expanded - increase of 280 terms from First Edition, reference to Cochrane included From the reviews of the First Edition: "This invaluable text explains the majority of clinical trial terms, in alphabetical order, that are likely to be found in clinical trial protocols, reports, regulatory guidelines, and published manuscripts... Fully comprehensive - provides definitions of clinical trial terms in one complete volume... Includes extensive use of graphs throughout." LA DOC STI "...covers a range of subject matter, with emphasis on medical, statistical, epidemiological and ethical terms... a useful adjunct to standard clinical trial texts... a reference source to keep within easy reach." TALANTA The Dictionary of Clinical Trials, Second Edition is a ‘must-have’ for all pharmaceutical companies who conduct a lot of clinical trials, in all or one therapeutic area. The book is also of interest for public health and health science workers, and for contract research organisations and departments of medicine, where medics are involved with clinical trials.
Who Consolidated Guidelines On Tuberculosis Module 3
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2020-06-22
Who Consolidated Guidelines On Tuberculosis Module 3 written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-22 with Medical categories.
The political declaration of the first United Nations (UN) high-level meeting on tuberculosis (TB) calls countries to diagnose and treat 40 million people with TB globally between 2018 and 2022. Traditionally, in most countries, TB diagnosis has been performed using sputum-smear microscopy, a method developed more than 100 years ago, with suboptimal sensitivity. In recent years new technologies have emerged based on the detection of mycobacterial DNA or mycobacterial antigens. Over the past decade the World Health Organization (WHO) has published a number of guidelines developed by WHO-convened Guideline Development Groups (GDGs), using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to summarize the evidence and to formulate policy recommendations and accompanying remarks. The present document "WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection" consolidates five guidelines developed by WHO between 2016 and 2020. Earlier guidelines on diagnostics that were not developed according to the GRADE approach have not been included in this document. The WHO Consolidated Guidelines on Tuberculosis will group all TB recommendations in one document and will be complemented by matching modules of an operational handbook. The handbook will provide practical advice on how to put in place the recommendations at the scale needed to achieve national and global impact. A range of new diagnostic technologies have been endorsed by WHO during the past decade. These are listed below: - real-time polymerase chain reaction (PCR) assays - for example, Xpert MTB/RIF(r) (Ultra) (cartridge-based) and TruenatTM (chip-based);- line probe assays (LPAs) - for example, GenoType(r) MTBDRplus v1 and v2, GenoscholarTM NTM+MDRTB II and GenoType(r) MTBDRsl;- loop-mediated isothermal amplification (LAMP) - for example, TB-LAMP; and- antigen detection in a lateral flow format (biomarker-based detection) - for example, Alere DetermineTM TB LAM Ag. The present "WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection" provides background, justification and recommendations on these technologies. The document includes new recommendations on molecular assays intended as initial tests for the diagnosis of pulmonary and extrapulmonary TB and rifampicin resistance in adults and children.