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Author :
Publisher :
ISBN 13 : 9781604282863
Total Pages : pages
Book Rating : 4.2/5 (828 download)
Download or read book Strategies for Risk-based Clinical Trial Monitoring and Inspections written by and published by . This book was released on 2015 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Jay Herson
Publisher : CRC Press
ISBN 13 : 1498784127
Total Pages : 266 pages
Book Rating : 4.4/5 (987 download)
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.
Author : Jianchang Lin
Publisher : Springer
ISBN 13 : 3319425684
Total Pages : 351 pages
Book Rating : 4.3/5 (194 download)
Download or read book Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics written by Jianchang Lin and published by Springer. This book was released on 2016-11-13 with total page 351 pages. Available in PDF, EPUB and Kindle. Book excerpt: The papers in this volume represent a broad, applied swath of advanced contributions to the 2015 ICSA/Graybill Applied Statistics Symposium of the International Chinese Statistical Association, held at Colorado State University in Fort Collins. The contributions cover topics that range from statistical applications in business and finance to applications in clinical trials and biomarker analysis. Each papers was peer-reviewed by at least two referees and also by an editor. The conference was attended by over 400 participants from academia, industry, and government agencies around the world, including from North America, Asia, and Europe.
Author : Richard C. Zink
Publisher : SAS Institute
ISBN 13 : 1629592331
Total Pages : 268 pages
Book Rating : 4.6/5 (295 download)
Download or read book Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS written by Richard C. Zink and published by SAS Institute. This book was released on 2014-07-01 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improve efficiency while reducing costs in clinical trials with centralized monitoring techniques using JMP and SAS. International guidelines recommend that clinical trial data should be actively reviewed or monitored; the well-being of trial participants and the validity and integrity of the final analysis results are at stake. Traditional interpretation of this guidance for pharmaceutical trials has led to extensive on-site monitoring, including 100% source data verification. On-site review is time consuming, expensive (estimated at up to a third of the cost of a clinical trial), prone to error, and limited in its ability to provide insight for data trends across time, patients, and clinical sites. In contrast, risk-based monitoring (RBM) makes use of central computerized review of clinical trial data and site metrics to determine if and when clinical sites should receive more extensive quality review or intervention. Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS presents a practical implementation of methodologies within JMP Clinical for the centralized monitoring of clinical trials. Focused on intermediate users, this book describes analyses for RBM that incorporate and extend the recommendations of TransCelerate Biopharm Inc., methods to detect potential patient-or investigator misconduct, snapshot comparisons to more easily identify new or modified data, and other novel visual and analytical techniques to enhance safety and quality reviews. Further discussion highlights recent regulatory guidance documents on risk-based approaches, addresses the requirements for CDISC data, and describes methods to supplement analyses with data captured external to the study database. Given the interactive, dynamic, and graphical nature of JMP Clinical, any individual from the clinical trial team - including clinicians, statisticians, data managers, programmers, regulatory associates, and monitors - can make use of this book and the numerous examples contained within to streamline, accelerate, and enrich their reviews of clinical trial data. The analytical methods described in Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS enable the clinical trial team to take a proactive approach to data quality and safety to streamline clinical development activities and address shortcomings while the study is ongoing. This book is part of the SAS Press
Author : Martin D. Hynes
Publisher : CRC Press
ISBN 13 : 1000654370
Total Pages : 310 pages
Book Rating : 4.0/5 (6 download)
Download or read book Preparing for FDA Pre-Approval Inspections written by Martin D. Hynes and published by CRC Press. This book was released on 2016-04-19 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. Th
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309172802
Total Pages : 88 pages
Book Rating : 4.3/5 (91 download)
Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)
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.
Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1482226383
Total Pages : 1007 pages
Book Rating : 4.4/5 (822 download)
Download or read book Handbook of Bioequivalence Testing written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2014-10-29 with total page 1007 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m
Author : P. Michael Dubinsky
Publisher : John Wiley & Sons
ISBN 13 : 1118949595
Total Pages : 554 pages
Book Rating : 4.1/5 (189 download)
Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309084881
Total Pages : 313 pages
Book Rating : 4.3/5 (9 download)
Download or read book Responsible Research written by Institute of Medicine and published by National Academies Press. This book was released on 2003-02-06 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants' safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants' contributions to the system, and Vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsorsâ€"but also including volunteers who may agree to serve as research participants.
Author : Steven Piantadosi
Publisher : Springer Nature
ISBN 13 : 3319526367
Total Pages : 2573 pages
Book Rating : 4.3/5 (195 download)
Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309163587
Total Pages : 589 pages
Book Rating : 4.3/5 (91 download)
Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
Author : Vera Mihajlovic-Madzarevic
Publisher : John Wiley & Sons
ISBN 13 : 0470920882
Total Pages : 186 pages
Book Rating : 4.4/5 (79 download)
Download or read book Clinical Trials Audit Preparation written by Vera Mihajlovic-Madzarevic and published by John Wiley & Sons. This book was released on 2010-09-29 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
Author : Frank Wells
Publisher : CRC Press
ISBN 13 : 0429533519
Total Pages : 234 pages
Book Rating : 4.4/5 (295 download)
Download or read book Fraud and Misconduct in Biomedical Research, 4th edition written by Frank Wells and published by CRC Press. This book was released on 2019-03-14 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its fourth edition, Fraud and Misconduct in Biomedical Research boasts an impressive list of contributors from around the globe and introduces a new focus for the book, transforming it from a series of monographs into a publication that will quickly become an essential textbook on all areas of research fraud and misconduct.Key features inclu
Author : Konstanze Frank
Publisher : GRIN Verlag
ISBN 13 : 3638394824
Total Pages : 13 pages
Book Rating : 4.6/5 (383 download)
Download or read book Global Regulations and Inspections - Research Quality Assurance written by Konstanze Frank and published by GRIN Verlag. This book was released on 2005-07-10 with total page 13 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essay from the year 2004 in the subject Medicine - Other, grade: good, Anglia Ruskin University, language: English, abstract: In 2001, when the Clinical Trial Directive 2001/20/EG was released in the European Union, Article 15 stated the regulations and legislation for government inspections of trial sites to be implemented by the Member States. The competent authorities of the Member States shall verify protection of the rights and welfare of trial subjects, compliance with the provisions of good clinical practice and the quality of data generated in clinical trials by appointing inspectors to inspect the sites concerned with any clinical trial. The European Medicines Agency (EMEA), which needs to be informed about the inspections, shall coordinate them. The inspections are performed on behalf of the European Union; the results should be accepted by all Member States. In Germany, authorisation of inspections is detailed in the German Drug Law and the corresponding GCP ordinance. The BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) is the responsible German regulatory authority. The UK competent authority is The Medicines and Healthcare products Regulatory Agency (MHRA). In the US inspections are regulated by the Food and Drug Administration (FDA). The specific instructions for inspecting Clinical Research Organisations (CROs) are given in the Bioresearch Monitoring Compliance Program No. 7348.810. What is an ‘inspection’? The definitions given in the different regulations are very similar. The ICH GCP Guidelines §1.29 [1] state: ‘Inspection’: the act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organisation’s (CRO’s) facilities, or at other establishment deemed appropriate by the regulatory authority(ies).
Author : eRegs & Guides
Publisher : eregs & guides
ISBN 13 :
Total Pages : 31 pages
Book Rating : 4./5 ( download)
Download or read book Good Clinical Practice eRegs & Guides - For Your Reference Book 8 written by eRegs & Guides and published by eregs & guides. This book was released on with total page 31 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
Author : Marina Malikova
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (116 download)
Download or read book Risk-Based Quality and Safety Management in Clinical Trials with Combination Products in Global Regulatory Environment written by Marina Malikova and published by . This book was released on 2017 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Background:Newly emerging products which combine drugs, devices, and biologics are expected to provide new opportuni- ties in bridging device and drug capabilities and establish synergies while bringing sophisticated combination products to consumers. The emergence of these novel products has triggered new regulatory, strategic, and technological challenges. While progress has been made at clarifying the issues that arise most frequently, regulatory authorities and product developers continue to struggle with complex regulatory and technical issues encompassing the development programs for combina- tion products. A risk-based approach requires not only a strategy but also tools to define key indicators to measure specific risks. Key risk indicators (KRIs) and risk-based quality management systems should focus on safety of research subjects and data integrity.Methods:We analyzed current regulatory guidelines throughout the life cycle of combination products and compared old and new approaches to risk-based quality and compliance management for current good manufacturing practices and during pre-clinical and clinical phases of combination products development. Causeu2013effect analysis for two major risk categories in clinical trials with combination products was performed.Results:The results of our analysis are based on observations from 15 clinical trials, which were conducted with combination products. Based on our findings, we proposed practical recommendations for the development of KRIs to improve conduct and ensure safety of research subjects in trials with combination products by utilizing risk-based quality management approach. Conclusion:Combination products, due to their specific nature, can increase risks while being tested in clinical trials. Metrics critical to risks and quality management should be linked to particular processes within development program for combination products. Ongoing collaboration between regulators, industry, and other stakeholders is essential to streamlining of the global combination entities development and approval process in a way that will produce safe and effective products for consumers.
