Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2011-10-25 with total page 673 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design. - Provides extensive coverage of the "study schema" and related features of study design - Offers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design - Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design - Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials - Includes chapters on core material and important ancillary topics, such as package inserts, consent forms, and safety reporting forms used in the United States, England and Europe - For complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser: http://tinyurl.com/awwutvn

Download or read book Clinical Trials written by Timothy M. Pawlik and published by Springer Nature. This book was released on 2020-03-10 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.

Download or read book Adaptive and Flexible Clinical Trials written by Richard Chin and published by CRC Press. This book was released on 2016-04-19 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in web-based real-time data entry and advances in statistic

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 The Comparative Coachability of Certain Types of Intelligence Tests written by Hsuan Shan Chen and published by . This book was released on 1928 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Clinical Trials in Neurology written by Bernard Ravina and published by Cambridge University Press. This book was released on 2012-04-12 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases. It introduces the reader to the key concepts underpinning trials in the neurosciences. This volume tackles the challenges of developing therapies for neurologic disorders from measurement of agents in the nervous system to the progression of clinical signs and symptoms through illustrating specific study designs and their applications to different therapeutic areas. Clinical Trials in Neurology covers key issues in Phase I, II and III clinical trials, as well as post-marketing safety surveillance. Topics addressed include regulatory and implementation issues, outcome measures and common problems in drug development. Written by a multidisciplinary team, this comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.

Download or read book Cluster Randomization Trials written by Sin-Ho Jung and published by CRC Press. This book was released on 2024-12-20 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oftentimes, small groups (called clusters) of individuals (called subunits) are randomized between treatment arms. Typically, clusters are families, classes, communities, surgeons operating patients, and so on. Such trials are called cluster randomization trials (CRTs). The subunits in each cluster share common frailties so that their outcomes tend to be positively correlated. Since clusters are independent, the data in two arms are independent in CRTs. In a clinical trial, multiple sites (such as teeth or ears) from each subject may be randomized between different treatment arms. In this case, the sites (subunits) of each subject (cluster) share common genetic, physiological, or environmental characteristics so that their observations tend to be positively correlated. This kind of trials are called subunit randomization trials (SRTs). In SRTs, dependency exists both within and between treatment arms. Individually randomized group treatment (IRGT) trials are composite of traditional independent subject randomization and CRTs. In an IRGT trial, the control arm is to treat patients individually, whereas the experimental arm is to treat patients using a group training, education, or treatment to increase the treatment effect by close interactions among patients. As a result, the outcome data of the control arm are independent as in traditional trials, but those in the experimental arm are correlated within each group (cluster) as in CRTs. Hence, two arms in IRGT trials have different dependency structures. Unlike standard CRTs, clusters of IRGT trials are usually organized after randomization. But statistically, they have identical statistical issues between the two types of trials, i.e., accounting for the dependency within each cluster. Although this book is entitled Cluster Randomization Trials, it covers all three types of trials (i.e., CRTs, SRTs, and IRGT trials) resulting in clustered data. For outcome variables of binary, continuous, and time-to-event types, we investigate generalized estimating equation type statistical tests and their sample size formulas. Also presented are random number generation algorithms for different types of outcome variables and randomization methods. The methods are discussed in terms of clinical trials, but can be used to design and analyze any types of experiments involving clustered data. This book also discusses statistical methods for various types of biomarker studies, including ROC methods, with clustered data. Key Features: Includes extensive statistical tests and their sample size formulas for various types of clinical trials resulting in clustered data. Handles different variable types of endpoints separately. Discusses algorithms to generate clustered binary and survival data that are useful for simulations. Covers statistical tests and sample size formulas for medical tests with clustered data.

Download or read book Innovative Strategies Statistical Solutions and Simulations for Modern Clinical Trials written by Mark Chang and published by CRC Press. This book was released on 2019-03-20 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.

Download or read book Design and Analysis of Clinical Trials written by Shein-Chung Chow and published by John Wiley & Sons. This book was released on 2013-09-30 with total page 838 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the Second Edition: “...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this Third Edition include: • New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine • A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies • Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts • New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT/QTc prolongation • A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines • An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development Design and Analysis of Clinical Trials, Third Edition continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students.

Download or read book Textbook of Clinical Trials in Oncology written by Susan Halabi and published by CRC Press. This book was released on 2019-04-24 with total page 708 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology. Key Features: Cutting-edge topics with appropriate technical background Built around case studies which give the work a "hands-on" approach Real examples of flaws in previously reported clinical trials and how to avoid them Access to statistical code on the book’s website Chapters written by internationally recognized statisticians from academia and pharmaceutical companies Carefully edited to ensure consistency in style, level, and approach Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others

Download or read book Fundamentals of Clinical Trials written by Lawrence M. Friedman and published by Springer Science & Business Media. This book was released on 1998 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.

Download or read book Statistical Design Monitoring and Analysis of Clinical Trials written by Weichung Joe Shih and published by CRC Press. This book was released on 2021-10-26 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.

Download or read book Data Monitoring Committees in Clinical Trials written by Susan S. Ellenberg and published by John Wiley & Sons. This book was released on 2019-01-14 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: The authoritative guide for Data Monitoring Committees—fully revised and updated The number of clinical trials sponsored by government agencies and pharmaceutical companies has grown in recent years, prompting an increased need for interim monitoring of data on safety and efficacy. Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and protecting the credibility and validity of the study. Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition offers practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees, providing a practical overview of the establishment, purpose, and responsibilities of these committees. Examination of topics such as the composition and independence of DMCs, statistical, philosophical and ethical considerations, and determining when a DMC is needed, presents readers with a comprehensive foundational knowledge of clinical trial oversight. Providing recent examples to illustrate DMC principles, this fully-updated guide reflects current developments and practices in clinical trial oversight and offers expanded coverage of emerging issues and challenges in the field. This new second edition covers the most current information on DMC policies, issues in monitoring trials using new designs, and recent trial publications relevant to DMC decision-making. • Presents practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees • Illustrates the types of challenging issues Data Monitoring Committees face in practical situations • Provides updated and expanded coverage of topics including regulatory and funding agency guidelines and trial designs and their associated demands and limitations • Includes a new chapter addressing legal issues that affect DMC members and discusses general litigation concerns relevant to clinical research • Expands treatment of current journal publications addressing DMC issues Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition is a must-have text for anyone engaged in DMC activities as well as trial sponsors, clinical trial researchers, regulatory and bioethics professionals, and those associated with clinical trials in academic, government and industry settings.

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.

Download or read book Statistical Monitoring of Clinical Trials written by Lemuel A. Moyé and published by Springer Science & Business Media. This book was released on 2006-02-28 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Monitoring of Clinical Trials: Fundamentals for Investigators introduces the investigator and statistician to monitoring procedures in clinical research. Clearly presenting the necessary background with limited use of mathematics, this book increases the knowledge, experience, and intuition of investigations in the use of these important procedures now required by the many clinical research efforts. The author provides motivated clinical investigators the background, correct use, and interpretation of these monitoring procedures at an elementary statistical level. He defines terms commonly used such as group sequential procedures and stochastic curtailment in non-mathematical language and discusses the commonly used procedures of Pocock, O’Brien–Fleming, and Lan–DeMets. He discusses the notions of conditional power, monitoring for safety and futility, and monitoring multiple endpoints in the study. The use of monitoring clinical trials is introduced in the context of the evolution of clinical research and one chapter is devoted to the more recent Bayesian procedures. From the reviews: "The author has a wealth of experience in this area and this is demonstrated throughout the text with relevant poignant examples." Short Book Reviews of the ISI, June 2006

Download or read book CRC Handbook of Sample Size Guidelines for Clinical Trials written by Jonathan J. Shuster and published by CRC Press. This book was released on 1990-09-25 with total page 868 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this unique volume is to help medical researchers design clinical trials to improve survival, remission duration, or time to recurrence of disease. Written in a user-friendly step-by-step format, this work enables the researcher-with no background in statistics-to determine sample size and write statistical considerations for their protocols. It provides critical language which can help with FDA submissions and/or research grants. It also provides the mathematical justification of the material at a level consistent with one year of undergraduate mathematical statistics. It presents survival analysis methods at a more elementary level than any known text. Filled with tables, figures, plus an extensive appendix, this one-of-a-kind reference is an absolute must for all clinical researchers and biostatisticians.

Download or read book Clinical Trials of Drugs and Biopharmaceuticals written by Chi-Jen Lee and published by CRC Press. This book was released on 2005-09-19 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical industry is on the verge of an exciting and challenging century. Advances in pharmaceutical sciences have dramatically changed the processes of discovery and development of new therapeutic drugs and, in turn, resulted in an extraordinary increase in the potential prophylactic and therapeutic interventions. In this atmosphere, an