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Clinical Trials Handbook

Clinical Trials Handbook Author Curtis L. Meinert
ISBN-10 9781118422793
Release 2012-10-10
Pages 600
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A systematic approach to all aspects of designing and conducting clinical trials The success or failure of clinical trials hinges on hundreds of details that need to be developed, often under less than ideal conditions. Written by one of the world's leading trialists, Clinical Trials Handbook: Design and Conduct provides clinicians with a complete guide to designing, conducting, and evaluating clinical trials—teaching them how to simplify the process and avoid costly mistakes. The author draws on his extensive clinical trials experience to outline all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. Along the way, practical advice is offered while also addressing a mix of logistical, ethical, psychological, behavioral, and administrative issues inherent to clinical trials. Topics of coverage include: Protocols for drug masking, controls, and treatment randomization Consent, enrollment, eligibility, and follow-up procedures Different types of sample size design and data collection and processing Working with study centers, research staff, and various committees Monitoring treatment effects and performance, and ensuring quality control Data analysis and access policies for study data and documents Clinical Trials Handbook is invaluable for practicing clinicians and trialists who would like to learn more about or improve their understanding of the design and execution of clinical trials. The book is also an excellent supplement for courses on clinical trials at the graduate level.



Clinical Trials Handbook

Clinical Trials Handbook Author Shayne Cox Gad
ISBN-10 0470466359
Release 2009-06-17
Pages 944
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Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.



A Comprehensive and Practical Guide to Clinical Trials

A Comprehensive and Practical Guide to Clinical Trials Author Delva Shamley
ISBN-10 9780128047309
Release 2017-06-07
Pages 210
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A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. Describes the entire clinical trial management process from start to finish in a step-by-step guide Provides best practice elements, including case studies, practical examples, activities, and checklists Accompanied by a website with PowerPoint slides and an image bank



Handbook for Clinical Trials of Imaging and Image Guided Interventions

Handbook for Clinical Trials of Imaging and Image Guided Interventions Author Nancy A. Obuchowski
ISBN-10 9781118849750
Release 2016-02-15
Pages 224
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Handbook for Clinical Trials of Imaging and Image-Guided Interventions is the first single-source, multi-disciplinary reference, based on the didactic sessions presented at the annual ‘Clinical Trials Methodology Workshop’ for radiologists, radiation oncologists and imaging scientists (sponsored by the Radiological Society of North America (RSNA)). It focuses on educating radiologists, radiation oncologists and those involved in imaging research with how to design and conduct clinical trials to evaluate imaging technology and imaging biomarkers. The internationally renowned contributors take a broad approach, starting with principles of technology assessment, and then move into specific topics covering the clinical trials of therapy and clinical research in imaging guided interventions including radiotherapy. They discuss the use of imaging as a predictor of therapeutic response, screening trial design, and the practicalities of how to run an efficient clinical trial and good working practices. Later chapters provide a comprehensive array of quantitative methods including: an introduction to statistical considerations in study design, biostatistical analysis methods and their role in clinical imaging research, methods for quantitative imaging biomarker studies, and an introduction to cost effectiveness analysis. Handbook for Clinical Trials of Imaging and Image-Guided Interventions will educate and prepare radiologists at all levels and in all capacities in planning and conducting clinical imaging trials.



Clinical Trials Dictionary

Clinical Trials Dictionary Author Curtis L. Meinert
ISBN-10 9781118315286
Release 2012-08-15
Pages 448
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A thoroughly updated new edition of the essential reference on the design, practice, and analysis of clinical trials Clinical Trials Dictionary: Terminology and Usage Recommendations, Second Edition presents clear, precise, meticulously detailed entries on all aspects of modern-day clinical trials. Written and compiled by one of the world’s leading clinical trialists, this comprehensive volume incorporates areas of medicine, statistics, epidemiology, computer science, and bioethics—providing a treasure trove of key terms and ideas. This new edition continues to supply readers with the A–Z terminology needed to design, conduct, and analyze trials, introducing a vocabulary for the characterization and description of related features and activities. More than 300 new entries are now included, reflecting the current usage practices and conventions in the field, along with usage notes with recommendations on when to use the term in question. Detailed biographical notes highlight prominent historical figures and institutions in the field, and an extensive bibliography has been updated to provide readers with additional resources for further study. The most up-to-date work of its kind, Clinical Trials Dictionary, Second Edition is an essential reference for anyone who needs to report on, index, analyze, or assess the scientific strength and validity of clinical trials.



Handbook of Neuroemergency Clinical Trials

Handbook of Neuroemergency Clinical Trials Author Brett E. Skolnick
ISBN-10 9780128041017
Release 2017-11-13
Pages 400
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Handbook of Neuroemergency Clinical Trials, Second Edition, focuses on the practice of clinical trials in acute neuroscience populations, or what have been called neuroemergencies. Neuroemergencies are complex, life-threatening diseases and disorders, often with devastating consequences, including death or disability. The overall costs are staggering in terms of annual incidence and costs associated with treatment and survival, yet despite their significance as public health issues, there are few drugs and devices available for definitive treatment. The book focuses on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. This volume provides neurologists, neuroscientists, and drug developers with a more complete understanding of the scientific and medical issues of relevance in designing and initiating clinical development plans for novel drugs intended for acute neuroscience populations. The editors provide the best understanding of the pitfalls associated with acute CNS drug development and the best information on how to approach and solve issues that have plagued drug development. Presents a comprehensive overview on clinical trials and drug development challenges in acute neuroscience populations Provides neurologists, neuroscientists and drug developers with a complete understanding of scientific and medical issues related to designing clinical trials Edited by leaders in the field who have designed and managed over 50 neuroemergency clinical trials



ClinicalTrials

ClinicalTrials Author Curtis L. Meinert
ISBN-10 9780195387889
Release 2012-03-27
Pages 665
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The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials.



Handbook for Clinical Research

Handbook for Clinical Research Author Flora Hammond, MD
ISBN-10 9781936287543
Release 2014-08-26
Pages 290
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The majority of physicians are poorly knowledgeable about statistics and research design, yet are expected to do clinical research and write articles (if in academia) or, at the very least, to read the literature critically and provide evidence-based care to patients. The basic skills involved are touched on very minimally in residency, but not in enough depth for an untrained investigator to successfully design or conduct a study, or analyze research findings in any meaningful way. This volume is intended as a “quick fix”, allowing readers to look up information rapidly about various design types and statistical methods to see what the pros, cons, and indications for each are. Research implementation, including regulatory issues and grant writing, is also covered. The book is unique in physical medicine and rehabilitation, and with the increased emphasis on outcomes measurement and push toward a national agenda for disability research, will appeal both to investigators planning and executing studies and clinicians looking to better understand how the findings impact their practice. A list of topics with an outline of headings for each of the sections is attached.



Clinical Research Manual

Clinical Research Manual Author Ruth Jennifer Cavalieri
ISBN-10 9781937554637
Release 2013-06-17
Pages 262
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Clinical Research Manual: Practical Tools and Templates for Managing Clinical Research is the "must-have" book for anyone working in the day-to-day operations of a research study or clinical trial. Filled with tools, techniques, and templates, this manual offers clinical researchers, principal investigators, and research coordinators the foundation they need to successfully organize complex trials.



Economic Evaluation in Clinical Trials

Economic Evaluation in Clinical Trials Author Henry A. Glick
ISBN-10 9780191508059
Release 2014-10-02
Pages 288
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It is becoming increasingly important to examine the relationship between the outcomes of a clinical trial and the costs of the medical therapy under study. The results of such analysis can affect reimbursement decisions for new medical technologies, drugs, devices or diagnostics. It can aid companies seeking to make claims about the cost-effectiveness of their product, as well as allowing early consideration of the economic value of therapies which may be important to improving initial adoption decisions. It is also vital for addressing the requirements of regulatory bodies. Economic Evaluation in Clinical Trials provides practical advice on how to conduct cost-effectiveness analyses in controlled trials of medical therapies. This new edition has been extensively rewritten and revised; topics discussed range from design issues such as the types of services that should be measured and price weights, to assessment of quality-adjusted life years. Illustrative materials, case histories and worked examples are included to encourage the reader to apply the methods discussed. These exercises are supported with datasets, programmes and solutions made available online.



Handbook of Statistics in Clinical Oncology Third Edition

Handbook of Statistics in Clinical Oncology  Third Edition Author John Crowley
ISBN-10 9781439862001
Release 2012-03-26
Pages 657
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Many new challenges have arisen in the area of oncology clinical trials. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of trials. The literature on adaptive trial designs and early stopping has been exploding. Inclusion of high-dimensional data and imaging techniques have become common practice, and statistical methods on how to analyse such data have been refined in this area. A compilation of statistical topics relevant to these new advances in cancer research, this third edition of Handbook of Statistics in Clinical Oncology focuses on the design and analysis of oncology clinical trials and translational research. Addressing the many challenges that have arisen since the publication of its predecessor, this third edition covers the newest developments involved in the design and analysis of cancer clinical trials, incorporating updates to all four parts: Phase I trials: Updated recommendations regarding the standard 3 + 3 and continual reassessment approaches, along with new chapters on phase 0 trials and phase I trial design for targeted agents. Phase II trials: Updates to current experience in single-arm and randomized phase II trial designs. New chapters include phase II designs with multiple strata and phase II/III designs. Phase III trials: Many new chapters include interim analyses and early stopping considerations, phase III trial designs for targeted agents and for testing the ability of markers, adaptive trial designs, cure rate survival models, statistical methods of imaging, as well as a thorough review of software for the design and analysis of clinical trials. Exploratory and high-dimensional data analyses: All chapters in this part have been thoroughly updated since the last edition. New chapters address methods for analyzing SNP data and for developing a score based on gene expression data. In addition, chapters on risk calculators and forensic bioinformatics have been added. Accessible to statisticians and oncologists interested in clinical trial methodology, the book is a single-source collection of up-to-date statistical approaches to research in clinical oncology.



Oxford Handbook of Clinical and Healthcare Research

Oxford Handbook of Clinical and Healthcare Research Author Sumantra Ray
ISBN-10 9780191502958
Release 2016-03-03
Pages 640
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The Oxford Handbook of Clinical and Healthcare Research is a practical, concise, and easy-to-use reference for the full range of clinical and healthcare research topics, while incorporating evidence based medicine. Comprehensively providing a wide breadth of knowledge, this handbook clearly covers both the qualitative and quantitative aspects. This handbook includes clear instructions on the legislative requirements as well as the practical requirements of commissioning, conducting, analysing, and reporting research for those in clinical or healthcare practice, education or training. This book has been written with Good Clinical Practice (GCP) education in mind, giving valuable information needed for the accredited certificates and diploma-level benchmark exams now commonly required by employers. Whether you need practical advice on setting up and running a trial, negotiating regulations, learning vital research skills, or to study the underpinning concepts of research methods, this handbook will give you the vital information, clinical evidence, and guidance you need.



Introduction to Statistical Methods for Clinical Trials

Introduction to Statistical Methods for Clinical Trials Author Thomas D. Cook
ISBN-10 9781584880271
Release 2007-11-19
Pages 464
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Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.



The Oxford Textbook of Clinical Research Ethics

The Oxford Textbook of Clinical Research Ethics Author Ezekiel J. Emanuel
ISBN-10 9780199768639
Release 2011-02-01
Pages 848
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The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.



The Lancet Handbook of Essential Concepts in Clinical Research

The Lancet Handbook of Essential Concepts in Clinical Research Author Kenneth F. Schulz
ISBN-10 UOM:39015064779559
Release 2006
Pages 223
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The needs of clinicians predominate throughout the text, but these needs overlap with those of researchers especially in chapters covering randomized controlled trials. For readers to assess trials accurately they need to understand relevant guidelines on the conduct of trials that are emerging from methodological research. In presenting these discussions to clinicians these chapters will help researchers who also do randomized trials and provide a methodological background that enhances the quality and quantity of their research productivity. Enables clinicians to read the medical literature more critically Chapters cover: descriptive studies, cohort studies, case control studies, bias, and screening tests Five chapters dedicated to randomized controlled trials



A Clinical Trials Manual From The Duke Clinical Research Institute

A Clinical Trials Manual From The Duke Clinical Research Institute Author Margaret Liu
ISBN-10 9781444357882
Release 2011-08-24
Pages 424
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"The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity." —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical "nuts and bolts" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.



Clinical Research Computing

Clinical Research Computing Author Prakash Nadkarni
ISBN-10 9780128031452
Release 2016-04-29
Pages 240
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Clinical Research Computing: A Practitioner’s Handbook deals with the nuts-and-bolts of providing informatics and computing support for clinical research. The subjects that the practitioner must be aware of are not only technological and scientific, but also organizational and managerial. Therefore, the author offers case studies based on real life experiences in order to prepare the readers for the challenges they may face during their experiences either supporting clinical research or supporting electronic record systems. Clinical research computing is the application of computational methods to the broad field of clinical research. With the advent of modern digital computing, and the powerful data collection, storage, and analysis that is possible with it, it becomes more relevant to understand the technical details in order to fully seize its opportunities. Offers case studies, based on real-life examples where possible, to engage the readers with more complex examples Provides studies backed by technical details, e.g., schema diagrams, code snippets or algorithms illustrating particular techniques, to give the readers confidence to employ the techniques described in their own settings Offers didactic content organization and an increasing complexity through the chapters