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| what is an intent to treat analysis: Principles and Practice of Clinical Trials Steven Piantadosi, Curtis L. Meinert, 2022-07-19 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. |
| what is an intent to treat analysis: The Prevention and Treatment of Missing Data in Clinical Trials National Research Council, Division of Behavioral and Social Sciences and Education, Committee on National Statistics, Panel on Handling Missing Data in Clinical Trials, 2010-12-21 Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data. |
| what is an intent to treat analysis: Clinical Trials Tom Brody, 2016-02-19 Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. - Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more - Extensively covers the study schema and related features of study design - Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials - Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers |
| what is an intent to treat analysis: Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide Agency for Health Care Research and Quality (U.S.), 2013-02-21 This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov) |
| what is an intent to treat analysis: Clinical Trials in Neurology Bernard Ravina, Jeffrey Cummings, Michael McDermott, R. Michael Poole, 2012-04-12 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. |
| what is an intent to treat analysis: An Approach to Evaluate the Effects of Concomitant Prescribing of Opioids and Benzodiazepines on Veteran Deaths and Suicides National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Care Services, Committee on Developing a Protocol to Evaluate the Concomitant Prescribing of Opioids and Benzodiazepine Medications and Veteran Deaths and Suicides, 2019-10-16 Opioid prescriptions for acute and chronic pain increased dramatically from the late 1990s into the current decade in both the civilian and the Department of Veterans Affairs and Department of Defense treatment environments. Similarly, prescriptions for benzodiazepines also increased significantly for anxiety and insomnia. Combinations of opioid and benzodiazepines have proven fatal when taken concurrently, with research demonstrating this phenomenon for nearly 40 years. This issue is exacerbated within the veteran population because of higher rates of pain, anxiety and other related health issues due to military life. An evaluation of the relationship between opioid and benzodiazepine medication practices at the VA is necessary to improve treatment for mental health and combat-related trauma for veterans. An Approach to Evaluate the Effects of Concomitant Prescribing of Opioids and Benzodiazepines on Veteran Deaths and Suicides investigates the effects of opioid initiation and tapering strategies in the presence of benzodiazepines in veterans. This report explores neurobiology and the principles of addiction and tolerance, in addition to the current use of opioids and benzodiazepines for treating pain and anxiety in both the veteran and general population. It also provides a protocol to evaluate the relationship between opioid and benzodiazepine medication practices. This framework is a critical foundation for further research to improve concomitant opioid and benzodiazepine medication practices for veterans and the general population. |
| what is an intent to treat analysis: Small Clinical Trials Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Small-Number-Participant Clinical Research Trials, 2001-01-01 Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a large trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement. |
| what is an intent to treat analysis: Heart Failure: A Companion to Braunwald's Heart Disease E-Book G. Michael Felker, Douglas L. Mann, 2019-02-06 Up-to-date, authoritative and comprehensive, Heart Failure, 4th Edition, provides the clinically relevant information you need to effectively manage and treat patients with this complex cardiovascular problem. This fully revised companion to Braunwald's Heart Disease helps you make the most of new drug therapies such as angiotensin receptor neprilysin inhibitors (ARNIs), recently improved implantable devices, and innovative patient management strategies. Led by internationally recognized heart failure experts Dr. G. Michael Felker and Dr. Douglas Mann, this outstanding reference gives health care providers the knowledge to improve clinical outcomes in heart failure patients. - Focuses on a clinical approach to treating heart failure, resulting from a broad variety of cardiovascular problems. - Covers the most recent guidelines and protocols, including significant new updates to ACC, AHA, and HFSA guidelines. - Covers key topics such as biomarkers and precision medicine in heart failure and new data on angiotensin receptor neprilysin inhibitors (ARNIs). - Contains four new chapters: Natriuretic Peptides in Heart Failure; Amyloidosis as a Cause of Heart Failure; HIV and Heart Failure; and Neuromodulation in Heart Failure. - Covers the pathophysiological basis for the development and progression of heart failure. - Serves as a definitive resource to prepare for the ABIM's Heart Failure board exam. - 2016 British Medical Association Award: First Prize, Cardiology (3rd Edition). |
| what is an intent to treat analysis: Principles and Practice of Clinical Trial Medicine Richard Chin, Bruce Y Lee, 2008-07-25 Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. - Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data - Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine - Expert authorship whose experience includes running clinical trials in an academic as well as industry settings - Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy |
| what is an intent to treat analysis: Epidemiology in Medicine Julie E. Buring, 1987 Harvard Medical School, Boston. Textbook for medical and public health students. |
| what is an intent to treat analysis: Statistical Analysis with Missing Data Roderick J. A. Little, Donald B. Rubin, 2019-03-21 An up-to-date, comprehensive treatment of a classic text on missing data in statistics The topic of missing data has gained considerable attention in recent decades. This new edition by two acknowledged experts on the subject offers an up-to-date account of practical methodology for handling missing data problems. Blending theory and application, authors Roderick Little and Donald Rubin review historical approaches to the subject and describe simple methods for multivariate analysis with missing values. They then provide a coherent theory for analysis of problems based on likelihoods derived from statistical models for the data and the missing data mechanism, and then they apply the theory to a wide range of important missing data problems. Statistical Analysis with Missing Data, Third Edition starts by introducing readers to the subject and approaches toward solving it. It looks at the patterns and mechanisms that create the missing data, as well as a taxonomy of missing data. It then goes on to examine missing data in experiments, before discussing complete-case and available-case analysis, including weighting methods. The new edition expands its coverage to include recent work on topics such as nonresponse in sample surveys, causal inference, diagnostic methods, and sensitivity analysis, among a host of other topics. An updated “classic” written by renowned authorities on the subject Features over 150 exercises (including many new ones) Covers recent work on important methods like multiple imputation, robust alternatives to weighting, and Bayesian methods Revises previous topics based on past student feedback and class experience Contains an updated and expanded bibliography The authors were awarded The Karl Pearson Prize in 2017 by the International Statistical Institute, for a research contribution that has had profound influence on statistical theory, methodology or applications. Their work has been no less than defining and transforming. (ISI) Statistical Analysis with Missing Data, Third Edition is an ideal textbook for upper undergraduate and/or beginning graduate level students of the subject. It is also an excellent source of information for applied statisticians and practitioners in government and industry. |
| what is an intent to treat analysis: Analysis of Observational Health Care Data Using SAS Douglas E. Faries, Andrew C. Leon, Josep Maria Haro, Robert L. Obenchain, 2010 This book guides researchers in performing and presenting high-quality analyses of all kinds of non-randomized studies, including analyses of observational studies, claims database analyses, assessment of registry data, survey data, pharmaco-economic data, and many more applications. The text is sufficiently detailed to provide not only general guidance, but to help the researcher through all of the standard issues that arise in such analyses. Just enough theory is included to allow the reader to understand the pros and cons of alternative approaches and when to use each method. The numerous contributors to this book illustrate, via real-world numerical examples and SAS code, appropriate implementations of alternative methods. The end result is that researchers will learn how to present high-quality and transparent analyses that will lead to fair and objective decisions from observational data. This book is part of the SAS Press program. |
| what is an intent to treat analysis: Multiple Imputation for Nonresponse in Surveys Donald B. Rubin, 2009-09-25 Demonstrates how nonresponse in sample surveys and censuses can be handled by replacing each missing value with two or more multiple imputations. Clearly illustrates the advantages of modern computing to such handle surveys, and demonstrates the benefit of this statistical technique for researchers who must analyze them. Also presents the background for Bayesian and frequentist theory. After establishing that only standard complete-data methods are needed to analyze a multiply-imputed set, the text evaluates procedures in general circumstances, outlining specific procedures for creating imputations in both the ignorable and nonignorable cases. Examples and exercises reinforce ideas, and the interplay of Bayesian and frequentist ideas presents a unified picture of modern statistics. |
| what is an intent to treat analysis: Dictionary of Pharmaceutical Medicine Gerhard Nahler, 2013-06-29 This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of important addresses of national and international health authorities. |
| what is an intent to treat analysis: Statistical Issues in Drug Research and Development Karl E. Peace, 2017-09-19 This book is a compilation of topics addressed by the ASA Biopharmaceutical Section work groups, including the etiology and evolution of the work groups, the work group guidelines and structure, and the statistical issues associated with clinical trials in clinical drug development programs. |
| what is an intent to treat analysis: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 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. |
| what is an intent to treat analysis: Cochrane Handbook for Systematic Reviews of Interventions Julian P. T. Higgins, Sally Green, 2008-11-24 Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research-based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com). The Cochrane Handbook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves. |
| what is an intent to treat analysis: Good Research Practice in Non-Clinical Pharmacology and Biomedicine Anton Bespalov, Martin C. Michel, Thomas Steckler, 2020-02-20 This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine. |
| what is an intent to treat analysis: The Lady Tasting Tea David Salsburg, 2002-05-01 An insightful, revealing history of the magical mathematics that transformed our world. The Lady Tasting Tea is not a book of dry facts and figures, but the history of great individuals who dared to look at the world in a new way. At a summer tea party in Cambridge, England, a guest states that tea poured into milk tastes different from milk poured into tea. Her notion is shouted down by the scientific minds of the group. But one man, Ronald Fisher, proposes to scientifically test the hypothesis. There is no better person to conduct such an experiment, for Fisher is a pioneer in the field of statistics. The Lady Tasting Tea spotlights not only Fisher's theories but also the revolutionary ideas of dozens of men and women which affect our modern everyday lives. Writing with verve and wit, David Salsburg traces breakthroughs ranging from the rise and fall of Karl Pearson's theories to the methods of quality control that rebuilt postwar Japan's economy, including a pivotal early study on the capacity of a small beer cask at the Guinness brewing factory. Brimming with intriguing tidbits and colorful characters, The Lady Tasting Tea salutes the spirit of those who dared to look at the world in a new way. |
| what is an intent to treat analysis: Randomization in Clinical Trials William F. Rosenberger, John M. Lachin, 2015-11-23 Praise for the First Edition “All medical statisticians involved in clinical trials should read this book...” - Controlled Clinical Trials Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, Randomization in Clinical Trials: Theory and Practice, Second Edition is the go-to guide for biostatisticians and pharmaceutical industry statisticians. Randomization in Clinical Trials: Theory and Practice, Second Edition features: Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adaptive randomization, including minimization techniques and inference New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers’ understanding Randomization in Clinical Trials: Theory and Practice, Second Edition is an excellent reference for researchers as well as applied statisticians and biostatisticians. The Second Edition is also an ideal textbook for upper-undergraduate and graduate-level courses in biostatistics and applied statistics. William F. Rosenberger, PhD, is University Professor and Chairman of the Department of Statistics at George Mason University. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and author of over 80 refereed journal articles, as well as The Theory of Response-Adaptive Randomization in Clinical Trials, also published by Wiley. John M. Lachin, ScD, is Research Professor in the Department of Epidemiology and Biostatistics as well as in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin is actively involved in coordinating center activities for clinical trials of diabetes. He is the author of Biostatistical Methods: The Assessment of Relative Risks, Second Edition, also published by Wiley. |
| what is an intent to treat analysis: Handbook of Neuroemergency Clinical Trials Brett E. Skolnick, Wayne M. Alves, 2017-11-13 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 |
| what is an intent to treat analysis: Statistical Thinking in Clinical Trials Michael A. Proschan, 2021-11-24 Statistical Thinking in Clinical Trials combines a relatively small number of key statistical principles and several instructive clinical trials to gently guide the reader through the statistical thinking needed in clinical trials. Randomization is the cornerstone of clinical trials and randomization-based inference is the cornerstone of this book. Read this book to learn the elegance and simplicity of re-randomization tests as the basis for statistical inference (the analyze as you randomize principle) and see how re-randomization tests can save a trial that required an unplanned, mid-course design change. Other principles enable the reader to quickly and confidently check calculations without relying on computer programs. The `EZ’ principle says that a single sample size formula can be applied to a multitude of statistical tests. The `O minus E except after V’ principle provides a simple estimator of the log odds ratio that is ideally suited for stratified analysis with a binary outcome. The same principle can be used to estimate the log hazard ratio and facilitate stratified analysis in a survival setting. Learn these and other simple techniques that will make you an invaluable clinical trial statistician. |
| what is an intent to treat analysis: Handbook of Pharmacogenomics and Stratified Medicine Sandosh Padmanabhan, 2014-04-28 Handbook of Pharmacogenomics and Stratified Medicine is a comprehensive resource to understand this rapidly advancing field aiming to deliver the right drug at the right dose to the right patient at the right time. It is designed to provide a detailed, but accessible review of the entire field from basic principles to applications in various diseases. The chapters are written by international experts to allow readers from a wide variety of backgrounds, clinical and non-clinical (basic geneticists, pharmacologists, clinicians, trialists, industry personnel, ethicists) to understand the principles underpinning the progress in this area, the successes, failures and the challenges ahead. To be accessible to the widest range of readers, the clinical application section introduces the disease process, existing therapies, followed by pharmacogenomics and stratified medicine details.Medicine is the cornerstone of modern therapeutics prescribed on the basis that its benefit should outweigh its risk. It is well known that people respond differently to medications and in many cases the risk-benefit ratio for a particular drug may be a gray area. The last decade has seen a revolution in genomics both in terms of technological innovation and discovering genetic markers associated with disease. In parallel there has been steady progress in trying to make medicines safer and tailored to the individual. This has occurred across the whole spectrum of medicine, some more than others. In addition there is burgeoning interest from the pharmaceutical industry to leverage pharmacogenomics for more effective and efficient clinical drug development. - Provides clinical and non-clinical researchers with practical information normally beyond their usual areas of research or expertise - Includes an basic principles section explaining concepts of basic genetics, genetic epidemiology, bioinformatics, pharmacokinetics and pharmacodynamics - Covers newer technologies– next generation sequencing, proteomics, metabolomics - Provides information on animal models, lymphoblastoid cell lines, stem cells - Provides detailed chapters on a wide range of disease conditions, implementation and regulatory issues - Includes chapters on the global implications of pharmacogenomics |
| what is an intent to treat analysis: Clinical Trials Stuart J. Pocock, 2013-07-17 This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience. |
| what is an intent to treat analysis: Users' Guides to the Medical Literature Gordon Guyatt, Drummond Rennie, Maureen O. Meade, Deborah J. Cook, 2008-03-01 The “essential” companion to the landmark Users' Guides to the Medical Literature - completely revised and updated! 5 STAR DOODY'S REVIEW! This second edition is even better than the original. Information is easier to find and the additional resources that will be available at www.JAMAevidence.com will provide readers with a one-stop source for evidence-based medicine.--Doody's Review Service Evidence-based medicine involves the careful interpretation of medical studies and its clinical application. And no resource helps you do it better-and faster-than Users' Guides to the Medical Literature: Essentials of Evidence-Based Clinical Practice. This streamlined reference distills the most clinically-relevant coverage from the parent Users' Guide Manual into one highly-focused, portable resource. Praised for its clear explanations of detailed statistical and mathematical principles, The Essentials concisely covers all the basic concepts of evidence-based medicine--everything you need to deliver optimal patient care. It's a perfect at-a-glance source for busy clinicians and students, helping you distinguish between solid medical evidence and poor medical evidence, tailor evidence-based medicine for each patient, and much more. Now in its second edition, this carry-along quick reference is more clinically relevant--and more essential--than ever! FEATURES Completely revised and updated with all new coverage of the basic issues in evidence-based medicine in patient care Abundant real-world examples drawn from the medical literature are woven throughout, and include important related principles and pitfalls in using clinical research in patient care decisions Edited by over 60 internationally recognized editors and contributors from around the globe Also look for JAMAevidence.com, a new interactive database for the best practice of evidence based medicine. |
| what is an intent to treat analysis: Practical Biostatistics Mendel Suchmacher, Mauro Geller, 2012-07-26 *Customized presentation for biological investigators with examples taken from current clinical trials in multiple disciplines. |
| what is an intent to treat analysis: Registries for Evaluating Patient Outcomes Richard E. Gliklich, Nancy A. Dreyer, 2014 |
| what is an intent to treat analysis: Positive Intelligence Shirzad Chamine, 2012 Chamine exposes how your mind is sabotaging you and keeping your from achieving your true potential. He shows you how to take concrete steps to unleash the vast, untapped powers of your mind. |
| what is an intent to treat analysis: The Oxford Handbook of Research Strategies for Clinical Psychology Jonathan S. Comer, Philip C. Kendall, 2013-05-09 The Oxford Handbook of Research Strategies for Clinical Psychology has recruited some of the field's foremost experts to explicate the essential research strategies currently used across the modern clinical psychology landscape that maximize both scientific rigor and clinical relevance. |
| what is an intent to treat analysis: Childhood Acute Lymphoblastic Leukemia Ajay Vora, 2017-04-21 This book provides a comprehensive and up-to-date review of all aspects of childhood Acute Lymphoblastic Leukemia, from basic biology to supportive care. It offers new insights into the genetic pre-disposition to the condition and discusses how response to early therapy and its basic biology are utilized to develop new prognostic stratification systems and target therapy. Readers will learn about current treatment and outcomes, such as immunotherapy and targeted therapy approaches. Supportive care and management of the condition in resource poor countries are also discussed in detail. This is an indispensable guide for research and laboratory scientists, pediatric hematologists as well as specialist nurses involved in the care of childhood leukemia. |
| what is an intent to treat analysis: Impact Evaluation Markus Fröhlich, Markus Frölich, Stefan Sperlich, 2019-03-21 Encompasses the main concepts and approaches of quantitative impact evaluations, used to consider the effectiveness of programmes, policies, projects or interventions. This textbook for economics graduate courses can also serve as a manual for professionals in research institutes, governments, and international organizations. |
| what is an intent to treat analysis: Modern Epidemiology Kenneth J. Rothman, Sander Greenland, Timothy L. Lash, 2008 The thoroughly revised and updated Third Edition of the acclaimed Modern Epidemiology reflects both the conceptual development of this evolving science and the increasingly focal role that epidemiology plays in dealing with public health and medical problems. Coauthored by three leading epidemiologists, with sixteen additional contributors, this Third Edition is the most comprehensive and cohesive text on the principles and methods of epidemiologic research. The book covers a broad range of concepts and methods, such as basic measures of disease frequency and associations, study design, field methods, threats to validity, and assessing precision. It also covers advanced topics in data analysis such as Bayesian analysis, bias analysis, and hierarchical regression. Chapters examine specific areas of research such as disease surveillance, ecologic studies, social epidemiology, infectious disease epidemiology, genetic and molecular epidemiology, nutritional epidemiology, environmental epidemiology, reproductive epidemiology, and clinical epidemiology. |
| what is an intent to treat analysis: Fundamentals of Clinical Trials Lawrence M. Friedman, Curt Furberg, David L. DeMets, 1998 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. |
| what is an intent to treat analysis: Medical Sciences E-Book Jeannette Naish, Denise Syndercombe Court, 2014-05-02 An integrated approach to teaching basic sciences and clinical medicine has meant that medical students have been driven to a range of basic science textbooks to find relevant information. Medical Sciences is designed to do the integration for you. In just one book, the diverse branches of medical science are synthesised into the appropriate systems of the human body, making this an invaluable aid to approaching the basics of medicine within in a clinical context. . An integrated approach to teaching basic sciences and clinical medicine has meant that medical students have been driven to a range of basic science textbooks to find relevant information. Medical Sciences does the integration for you. In just one book, the diverse branches of medical science are synthesised into the appropriate systems of the human body, making this an invaluable aid to approaching the basics of medicine within in a clinical context. Eleven new contributors. Completely new chapters on Biochemistry and cell biology, Genetics, The nervous system, Bones, muscle and skin, Endocrine and reproductive systems, The cardiovascular system, The renal system and Diet and nutrition. Completely revised and updated throughout with over 35 new illustrations . Expanded embryology sections with several new illustrations. |
| what is an intent to treat analysis: Moderate to Severe Psoriasis, Fourth Edition John Y. M. Koo, Ethan C. Levin, Argentina Leon, Jashin J. Wu, Alice B. Gottlieb, 2014-03-18 Written by experts in the dermatology field, this new fourth edition of Moderate-to-Severe Psoriasis discusses the current use of biologics and other pharmacologic and phototherapy treatments for moderate-to-severe psoriasis. Illustrated with high quality color figures, this standalone text emphasizes safe and effective treatments for the psoriasis patient that are perfect for the dermatologist in daily practice. New to this edition are chapters on day treatment programs, new agents, erythrodermic and pustular psoriasis, special populations, and pharmacogenetics. |
| what is an intent to treat analysis: A Question Of Intent David Kessler, 2002-03-21 Tobacco companies had been protecting their turf for decades. They had congressmen in their pocket. They had corrupt scientists who made excuses about nicotine, cancer and addiction. They had hordes of lawyers to threaten anyone -- inside the industry or out -- who posed a problem. They had a whole lot of money to spend. And they were good at getting people to do what they wanted them to do. After all, they had already convinced millions of Americans to take up an addictive, unhealthy, and potentially deadly habit. David Kessler didn't care about all that. In this book he tells for the first time the thrilling detective story of how the underdog FDA -- while safeguarding the nation's food, drugs, and blood supply -- finally decided to take on one of the world's most powerful opponents, and how it won. Like A Civil Action or And the Band Played On, A Question of Intent weaves together science, law, and fascinating characters to tell an important and often unexpectedly moving story. We follow Kessler's team of investigators as they race to find the clues that will allow the FDA to assert jurisdiction over cigarettes, while the tobacco companies and their lawyers fight back -- hard. Full of insider information and drama, told with wit, and animated by its author's moral passion, A Question of Intent reads like a Grisham thriller, with one exception -- everything in it is true. |
| what is an intent to treat analysis: Pragmatic Randomized Clinical Trials Cynthia J. Girman, Mary E. Ritchey, 2021-04-14 Pragmatic Randomized Clinical Trials Using Primary Data Collection and Electronic Health Records addresses the practical aspects and challenges of the design, implementation and dissemination of pragmatic randomized trials. The book contains chapters encompassing common designs, along with the advantages and limitations of such designs, analytic aspects in planning trials and estimating sample size, and how to use patient partners to help design and operationalize such trials. Pragmatic trials conducted using primary data collection and trials embedded in electronic health records - including electronic medical records and administrative insurance claims - are addressed. This comprehensive resource is valuable not only for biostatitians, but also for several members of biomedical field who are interested in applying pragmatic randomized clinical trials in their research. Brings typical designs and challenges of pragmatic randomized clinical trials (pRCTs) Encompasses analytic aspects for sample size determination of such trials Discusses real cases on operational challenges in launching and conducting pRCTs in electronic health records |
| what is an intent to treat analysis: Field Experiments Alan S. Gerber, Donald P. Green, 2012 A brief, authoritative introduction to field experimentation in the social sciences. Written by two leading experts on experimental methods, this concise text covers the major aspects of experiment design, analysis, and interpretation in clear language. Students learn how to design randomized experiments, analyze the data, and interpret the findings. Beyond the authoritative coverage of the basic methodology, the authors include numerous features to help students achieve a deeper understanding of field experimentation, including rich examples from the social science literature, problem sets and discussions, data sets, and further readings. |
| what is an intent to treat analysis: Methodological Challenges in Biomedical HIV Prevention Trials Institute of Medicine, Board on Global Health, Committee on the Methodological Challenges in HIV Prevention Trials, 2008-05-13 The number of people infected with HIV or living with AIDS is increasing at unprecedented rates as various scientists, organizations, and institutions search for innovative solutions to combating and preventing the disease. At the request of the Bill & Melinda Gates Foundation, Methodological Challenges in Biomedical HIV Prevention Trials addresses methodological challenges in late-stage nonvaccine biomedical HIV prevention trials with a specific focus on microbicide and pre-exposure prophylaxis trials. This book recommends a number of ways to improve the design, monitoring, and analysis of late-stage clinical trials that evaluate nonvaccine biomedical interventions. The objectives include identifying a beneficial method of intervention, enhancing quantification of the impact, properly assessing the effects of using such an intervention, and reducing biases that can lead to false positive trial results. According to Methodological Challenges in Biomedical HIV Prevention Trials, the need to identify a range of effective, practical, and affordable preventive strategies is critical. Although a large number of promising new HIV prevention strategies and products are currently being tested in late-stage clinical trials, these trials face a myriad of methodological challenges that slow the pace of research and limit the ability to identify and fully evaluate effective biomedical interventions. |
| what is an intent to treat analysis: Designing Clinical Research Stephen B. Hulley, 2007 This third edition sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology and offers an updated syllabus for conducting a clinical research workshop. |
INTENT Definition & Meaning - Merriam-Webster
The meaning of INTENT is a usually clearly formulated or planned intention : aim. How to use intent in a sentence. Synonym Discussion of Intent.
INTENT | English meaning - Cambridge Dictionary
INTENT definition: 1. giving all your attention to something: 2. to be determined to do or achieve something: 3. the…. Learn more.
INTENT Definition & Meaning | Dictionary.com
Intent definition: something that someone is intending or meaning to do or achieve; purpose or objective.. See examples of INTENT used in a sentence.
INTENT Synonyms: 209 Similar and Opposite Words | Merriam ...
Synonyms for INTENT: purpose, intention, goal, plan, aim, objective, idea, object; Antonyms of INTENT: means, way, method, hesitant, unresolved, undetermined, …
Intent | API reference - Android Developers
Extend by device; Build apps that give your users seamless experiences from phones to tablets, watches, headsets, and more.
INTENT Definition & Meaning - Merriam-Webster
The meaning of INTENT is a usually clearly formulated or planned intention : aim. How to use intent in a sentence. Synonym Discussion of Intent.
INTENT | English meaning - Cambridge Dictionary
INTENT definition: 1. giving all your attention to something: 2. to be determined to do or achieve something: 3. the…. Learn more.
INTENT Definition & Meaning | Dictionary.com
Intent definition: something that someone is intending or meaning to do or achieve; purpose or objective.. See examples of INTENT used in a sentence.
INTENT Synonyms: 209 Similar and Opposite Words | Merriam ...
Synonyms for INTENT: purpose, intention, goal, plan, aim, objective, idea, object; Antonyms of INTENT: means, way, method, hesitant, unresolved, undetermined, uncertain, doubtful
Intent | API reference - Android Developers
Extend by device; Build apps that give your users seamless experiences from phones to tablets, watches, headsets, and more.
Intent - Definition, Meaning & Synonyms | Vocabulary.com
If you have an intent, you have a motive or purpose. Intention and intent are synonyms, but with a subtle difference. Intention implies a general desire or plan to accomplish something, while intent …
intent noun - Definition, pictures, pronunciation and usage ...
Definition of intent noun from the Oxford Advanced Learner's Dictionary. intent (to do something) what you intend to do synonym intention. She denies possessing the drug with intent to supply. …
What does intent mean? - Definitions.net
What does intent mean? This dictionary definitions page includes all the possible meanings, example usage and translations of the word intent. The purpose of something that is intended. …
Intent - definition of intent by The Free Dictionary
1. something that is intended; purpose; design; intention: The original intent was to raise funds. 2. the act or fact of intending, as to do something: criminal intent. 3. Law. the state of a person's …
INTENT definition and meaning | Collins English Dictionary
If you are intent on doing something, you are eager and determined to do it. If someone does something in an intent way, they pay great attention to what they are doing. She looked from one …
