Download or read book Recent Advances in Clinical Trial Design and Analysis written by Peter F. Thall and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 263 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials have two purposes -- to treat the patients in the trial, and to obtain information which increases our understanding of the disease and especially how patients respond to treatment. Statistical design provides a means to achieve both these aims, while statistical data analysis provides methods for extracting useful information from the trial data. Recent advances in statistical computing have enabled statisticians to implement very rapidly a broad array of methods which previously were either impractical or impossible. Biostatisticians are now able to provide much greater support to medical researchers working in both clinical and laboratory settings. As our collective toolkit of techniques for analyzing data has grown, it has become increasingly difficult for biostatisticians to keep up with all the developments in our own field. Recent Advances in Clinical Trial Design and Analysis brings together biostatisticians doing cutting-edge research and explains some of the more recent developments in biostatistics to clinicians and scientists who work in clinical trials.
Download or read book Quality of Life Assessment in Clinical Trials written by Maurice J. Staquet and published by Oxford University Press, USA. This book was released on 1998 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: Researchers in all clinical fields are becoming increasingly aware of the importance of quality of life measurements in judging the efficacy of a given treatment, and it is becoming more common for psychological criteria to play an important role in the evaluation of therapies. In the past ten years a number of methods have been developed for carrying out such assessments. Quality of life research does however use special statistical methods which might well be unfamiliar to the clinician. Quality of life assessment in clinical trials: methods and practice explores these methods in a non-mathematical manner, comparing and contrasting the tools available to the clinician, and highlighting any potential pitfalls. It describes the methods used to collect and analyse quality of life data. The book will have widespread appeal to clinical trialists and researchers from a wide range of specialties.
Download or read book Assessing Quality of Life in Clinical Trials written by Peter M. Fayers and published by . This book was released on 2005 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: Researchers in all clinical fields are fully aware of the importance of Quality of Life measurements in judging the efficacy of a given treatment. Psychological criteria play an important role in this evaluation. Assessment of Quality of Life in Clinical Trials: methods and practice explores the current state of the art and illustrates the benefits and potential of health related quality of life assessment in clinical trials. It covers a wide range of analytical issues, emphasizing new and innovative approaches that are of practical and clinical importance.
Download or read book Quality of Life written by Peter M. Fayers and published by John Wiley & Sons. This book was released on 2013-05-23 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality of life studies form an essential part of the evaluation of any treatment. Written by two authors who are well respected within this field, Quality of Life: The Assessment, Analysis and Interpretation of Patient-reported Outcomes, Second Edition lays down guidelines on assessing, analysing and interpreting quality of life data. The new edition of this standard book has been completely revised, updated and expanded to reflect many methodological developments emerged since the publication of the first edition. Covers the design of instruments, the practical aspects of implementing assessment, the analyses of the data, and the interpretation of the results Presents all essential information on Quality of Life Research in one comprehensive volume Explains the use of qualitative and quantitative methods, including the application of basic statistical methods Includes copious practical examples Fills a need in a rapidly growing area of interest New edition accommodates significant methodological developments, and includes chapters on computer adaptive testing and item banking, choosing an instrument, systematic reviews and meta analysis This book is of interest for everyone involved in quality of life research, and it is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and practitioners in the fields of cancer and other chronic diseases. Reviews of the First Edition – Winner of the first prize in the Basis of Medicine Category of the BMA Medical Book Competition 2001: “This book is highly recommended to clinicians who are actively involved in the planning, analysis and publication of QoL research.” CLINICAL ONCOLOGY “This book is highly recommended reading.” QUALITY OF LIFE RESEARCH
Download or read book Quality of Life written by Peter M. Fayers and published by John Wiley & Sons. This book was released on 2016-01-19 with total page 648 pages. Available in PDF, EPUB and Kindle. Book excerpt: The assessment of patient reported outcomes and health-related quality of life continue to be rapidly evolving areas of research and this new edition reflects the development within the field from an emerging subject to one that is an essential part of the assessment of clinical trials and other clinical studies. The analysis and interpretation of quality-of-life assessments relies on a variety of psychometric and statistical methods which are explained in this book in a non-technical way. The result is a practical guide that covers a wide range of methods and emphasizes the use of simple techniques that are illustrated with numerous examples, with extensive chapters covering qualitative and quantitative methods and the impact of guidelines. The material in this new third edition reflects current teaching methods and content widened to address continuing developments in item response theory, computer adaptive testing, analyses with missing data, analysis of ordinal data, systematic reviews and meta-analysis. This book is aimed at everyone involved in quality-of-life research and is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and clinical practice.
Download or read book Quality of Life and Pharmacoeconomics written by Joyce A. Cramer and published by Lippincott Williams & Wilkins. This book was released on 1998 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on Dr. Spilker's classic Quality of Life and Pharmacoeconomics in Clinical Trials, 2nd Edition, this streamlined sourcebook offers an easy-to-understand introduction to an increasingly critical aspect of health care. Seven succinct sections review key aspects of health-related quality of life and the essentials of pharmacoeconomics, providing expert answers to your most pressing questions: What generic HRQOL and disease-specific assessments are available? How are these scales chosen, used, and interpreted? What instruments do I need...and where can I find them? What is the relationship between pharmacoeconomics and quality of life? Between outcomes research and quality of life? Well-organized and easy to use, Quality of Life and Pharmacoeconomics: An Introduction will become a standard textbook for professionals and students in all areas of medical research and practice.
Download or read book Design and Analysis of Quality of Life Studies in Clinical Trials written by Diane L. Fairclough and published by CRC Press. This book was released on 2002-03-28 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: More and more frequently, clinical trials include the evaluation of Health-Related Quality of Life (HRQoL), yet many investigators remain unaware of the unique measurement and analysis issues associated with the assessment of HRQoL. At the end of a study, clinicians and statisticians often face challenging and sometimes insurmountable analytic problems. Design and Analysis of Quality of Life Studies in Clinical Trials details these issues and presents a range of solutions. Written from the author's extensive experience in the field, it focuses on the very specific features of QoL data: its longitudinal nature, multidimensionality, and the problem of missing data. The author uses three real clinical trials throughout her discussions to illustrate practical implementation of the strategies and analytic methods presented. As Quality of Life becomes an increasingly important aspect of clinical trials, it becomes essential for clinicians, statisticians, and designers of these studies to understand and meet the challenges this kind of data present. In this book, SAS and S-PLUS programs, checklists, numerous figures, and a clear, concise presentation combine to provide readers with the tools and skills they need to successfully design, conduct, analyze, and report their own studies.
Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Quality of Life Assessment Key Issues in the 1990s written by S.R. Walker and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 491 pages. Available in PDF, EPUB and Kindle. Book excerpt: It was over five years ago that the Centre for Medicines Research organized a workshop entitled "Quality of Life: Assessment and Application". This workshop brought together a unique group of participants, some of whom had been involved in studies on quality of life for well over a decade, whilst others were meeting the subject for the first time. This blend of experienced researchers and enthusiastic newcomers was a great stimulus to the discus sions which followed individual presentations as well as that resulting from the study groups. In the ensuing publication, a balance was sought between a consideration of the complex principles underlying the assessment of quality of life and the application of such assessments to specific clinical conditions which necessitated this approach. The organization in 1991 of a second workshop entitled "Quality of Life Assessment: Key Issues in the 1990s" resulted in a further consideration of the quality of life philosophy, concepts and key instruments together with an update on assessing quality of life in a number of major disease areas. Of particular importance was an examination of various viewpoints concerned with ethical questions and their implications, and quality oflife from industry, regulatory and health care purchasers' perspectives. As a result of this second workshop, the editors of the original book referred to above decided to produce a second edition with a number of updates and additional chapters.
Download or read book Quality of Life and Pharmacoeconomics in Clinical Trials written by Bert Spilker and published by Lippincott Williams & Wilkins. This book was released on 1996 with total page 1259 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Second Edition of this groundbreaking work refines the art and science of quality of life assessment and pharmacoeconomics and redefines the role of these evaluation parameters in clinical trials and health care decision-making. Dr. Spilker has assembled more than 200 experts from diverse clinical, research, and social science disciplines to provide a comprehensive reference on the methodology, interpretation, and use of quality of life and pharmacoeconomic studies. Expanded to four times its predecessor's size and scope, the Second Edition features: all-new sections on pharmacoeconomics and crucial health policy issues such as outcomes research a new, extensive section on cross-cultural and cross-national issues in quality of life assessment detailed information on specific tests and measures of quality of life comprehensive guidelines on choosing and administering tests and analyzing, interpreting, and presenting data many chapters on new topics such as phenomenology, assessment of spiritual status, and alternative/complementary medical treatments.
Download or read book Quality of Life Assessment International Perspectives written by John Orley and published by Springer. This book was released on 2011-12-13 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Considerable data and expertise have accumulated in the assessment of quality of life, but to date this assessment has largely been restricted to the devel- ment of instruments that are used only in the setting in which they were dev- oped. The chapters of this book, taken together, apply this expertise to a re- tively new area: international quality of life assessment, that is to say, consid- ing quality of life from an international perspective, and developing methods for the assessment of quality of life that can be used in more than one cultural setting. The World Health Organization (WHO) initiatives in the area of inter- tional quality of life assessment arose for several compelling reasons. The World Health Organization has a commitment to equitable and accessible health care for all. This commitment refers not only to health in its narrow sense of the absence of disease and impairment, but to health as astate of physical, mental and social well-being. Disease and impairment affect not just the physical domain of life but also a person's psychological state, level of - dependence and social relationships. This is a reality not yet fully reflected in health care settings. The broadening in focus in the measurement of health to include indicators which address this more holistic sense of health is a welcome emerging trend. The primary aim of any health intervention is to maximise health and minimise disease, thereby enhancing patients' quality of life.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Download or read book Clinical Research Methods for Surgeons written by David F. Penson and published by Springer Science & Business Media. This book was released on 2007-11-06 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: With his keen analytical mind and penchant for organization, Charles Darwin would have made an excellent clinical investigator. Unfortunately for surgery, his early exposure at Edinburgh to the brutality of operations in 1825 convinced him to reject his father’s plan for his career and pursue his interest in nature. His subsequent observations of how environmental pressures shaped the development of new species provided the essential mechanism to explain evolution and the disappearance of those species that failed to adapt. Today, surgeons face the same reality as new technology, progressive regulation by government and payers, medico-legal risks, and public demands for proof of performance force changes in behavior that our predecessors never imagined. We know that surgeons have always prided themselves on accurate documentation of their results, including their complications and deaths, but observational studies involving a single surgeon or institution have given way to demands for controlled interventional trials despite the inherent difficulty of studying surgical patients by randomized, blinded techniques. That is why this book is so timely and important. In a logical and comprehensive approach, the authors have assembled a group of experienced clinical scientists who can demonstrate the rich variety of techniques in epidemiology and statistics for reviewing existing publications, structuring a clinical study, and analyzing the resulting data.
Download or read book Statistical Methods for Quality of Life Studies written by Mounir Mesbah and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: On October 16 and 17, 2000, we hosted an international workshop entitled "Statistical Design, Measurement, and Analysis of Health Related Quality of Life." The workshop was held in the beautiful city of Arradon, South Brittany, France with the main goal of fostering an interdisciplinary forum for discussion of theoretical and applied statistical issues arising in studies of health-related quality of life (HRQoL). Included were biostatisticians, psychometricians and public health professionals (e.g., physicians, sociologists, psychologists) active in the study ofHRQoL. In assembling this volume, we invited each conference participant to contribute a paper based on his or her presentation and the ensuing and very interesting discussions that took place in Arradon. All papers were peer-reviewed, by anonymous reviewers, and revised before final editing and acceptance. Although this process was quite time consuming, we believe that it greatly improved the volume as a whole, making this book a valuable contribution to the field ofHRQoL research. The volume presents a broad spectrum of papers presented at the Workshop, and thus illustrates the range of current research related to the theory, methods and applications of HRQoL, as well as the interdisciplinary nature ofthis work. Following an introduction written by Sir David Cox, it includes 27 articles organized into the following chapters.
Download or read book Measuring Health Related Quality of Life in Children and Adolescents written by Dennis Drotar and published by Psychology Press. This book was released on 2014-06-03 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume's purpose is to describe concepts and methods concerning assessment of health-related quality of life (HRQOL) in children and adolescents with a special focus on chronic health conditions. The impetus for this book came from a recognition of the increasing importance of HRQOL assessments in the evaluation of treatment outcomes and the need to increase the utilization of HRQOL assessments in research and clinical applications with a range of pediatric populations. The need to develop a volume that describes new research and clinical applications concerning this topic stemmed from several recent developments. There is a continuing need for evaluations of the efficacy of medical treatments for children and adolescents, including those with chronic health conditions. To address these critical unmet needs in the field of HRQOL assessment, and to advance scientific methods and clinical applications in this field, a conference was held at Case Western Reserve University. The conference set out to summarize current information concerning the development and implementation of measures of HRQOL assessment, to identify and consider key conceptual and methodological issues in research concerning the measurement of HRQOL, and to recommend priorities to advance the state-of-the-art in research and clinical applications of QOL assessment in children and adolescents with chronic health conditions. This volume summarizes and synthesizes the information that was presented by the conference participants in a series of lively discussions and chapters that were based on the presentations.
Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Individual Quality of Life written by C R B Joyce and published by Psychology Press. This book was released on 2013-01-11 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rubric "Quality of Life" first came to the explicit attention of the medical profession a little over thirty years ago. Despite the undoubted fact that each one of us has his or her own Quality of Life, be it good or bad, there is still no general agreement about its definition, or the manner in which it should be evaluated. Although much has been written about quality of life, this work has been largely concerned with population-based studies, especially in health policy and health economics. The importance of "individual" quality of life has been neglected, in part because of a failure to define quality of life itself with sufficient care, in part perhaps because of a belief that it is impossible to develop a meaningful method of measuring individual variables. The editors of this book believe that the primary focus of quality of life is and must continue to be the individual, who alone can define it and assess its changing personal significance. The challenge of presenting this belief
