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 However, if the DSMB stops a study, the IRB must be notified immediately so that the study's approval can be withdrawn.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.

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.

Download or read book WHO consolidated guidelines on tuberculosis Module 4 written by World Health Organization and published by World Health Organization. This book was released on 2020-06-15 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Good Informatics Practices GIP Module Data Management written by Robert Barr and published by HIMSS. This book was released on with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Fundamentals of Biologicals Regulation written by Rebecca Sheets and published by Academic Press. This book was released on 2017-12-01 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

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.

Download or read book The Quintessence of Basic and Clinical Research and Scientific Publishing written by Gowraganahalli Jagadeesh and published by Springer Nature. This book was released on 2023-11-01 with total page 926 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Dictionary for Clinical Trials written by Simon Day and published by John Wiley & Sons. This book was released on 2007-04-30 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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.

Download or read book The CRA s Guide to Monitoring Clinical Research written by Karen E. Woodin and published by CenterWatch. This book was released on 2003-01-01 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book WHO consolidated guidelines on tuberculosis Module 3 written by World Health Organization and published by World Health Organization. This book was released on 2020-06-22 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Data and Safety Monitoring Committees in Clinical Trials Second Edition written by Jay Herson and published by CRC Press. This book was released on 2016-12-19 with total page 179 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. ? ? ? ? ? ? ? ? ? ? ? ? ?

Download or read book New Drug Approval Process written by Richard A. Guarino and published by CRC Press. This book was released on 2016-04-19 with total page 550 pages. Available in PDF, EPUB and Kindle. Book excerpt: The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.Updated chapters include:advances in international regulatory requirements, including ICH guidelines and harmonizationa step-by-step

Download or read book Practical Considerations for Adaptive Trial Design and Implementation written by Weili He and published by Springer. This book was released on 2014-10-15 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues faced in trial implementation. Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.

Download or read book ClinicalTrials written by Curtis L. Meinert PhD and published by Oxford University Press. This book was released on 2012-02-17 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 1986, this landmark text is the definitive guide to clinical trials, written by one of the leading experts in the field. This fully-updated second edition continues to be the most authoritative reference text on randomized clinical trials. It contains a wealth of practical information on the design, conduct, and analysis of both single center and multicenter trials. No other book on clinical trials offers as much detail on such issues as sample size calculation, stratification and randomization, data systems design, development of consent forms, publication policies, preparation of funding requests, and reporting procedures. While the basics of design, conduct, and analysis of clinical trials remain the same, there have been significant changes since the first edition of Clinical Trials was published two decades ago. In this new edition, the author discusses the refinements and improvements made to methods and procedures, changes in the policies and guidelines underlying trials, as well as requirements for registration of trials. He also discusses current practices for data sharing, for gender representation, for treatment effects monitoring, and for ethical standards of clinical trials. The importance of the randomized controlled trial has grown significantly over time and they are now the cornerstone of all evidence-based medicine. Still rich in tables, checklists, charts, and other resources for the trialist, the second edition of Clinical Trials is an indispensable reference for clinicians, biostaticians, epidemiologists, and anyone involved in the design and implementation of a clinical trial.

Download or read book Drug and Biological Development written by Ronald P. Evens and published by Springer Science & Business Media. This book was released on 2007-08-14 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals (MD, PharmD, PhD), at universities. The format is a set of figures, tables and lists, along with detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. The editors and authors of the book are industry and research experts in a variety of disciplines.

Download or read book Stephens Detection of New Adverse Drug Reactions written by John Talbot and published by John Wiley & Sons. This book was released on 2004-11-19 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: A key text for all those involved in pharmacovigilance. Detection of new adverse drug reactions is fundamental to the protection of patients from harm that may occur as a result of medication. This book explores the methods used to investigate new adverse drug reactions, discussing all elements from the scientific background and animal toxicology through to worldwide regulatory and ethical issues. Stephens' Detection of New Adverse Drug Reactions provides comprehensive and up-to-date coverage of material fundamentally important to all those active in the field, whether they work in the pharmaceutical industry, drug regulatory authorities or in academia. The fifth edition of this classic reference work includes new chapters on: vaccine safety surveillance managing drug safety issues with marketed products operational aspects of drug safety function safety of biotechnology products future of pharmacovigilance Reviews of previous editions: "This book surpasses all its educational aims. Not only is the subject matter covered comprehensively but the material is presented in a very user-friendly manner. The editors have succeeded in producing a highly-specific, definitive reference book which doubles as a most enjoyable read." —Commended by the 1999 BMA Medical Book Competition "For anyone entering the field of adverse reaction monitoring one could not wish for a better primer" —International Journal of Risk and Safety in Medicine