Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309042860 Category : Medical Languages : en Pages : 241
Book Description
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Author: Annetine C. Gelijns Publisher: Medical Innovation at the Cros ISBN: Category : Medical Languages : en Pages : 248
Book Description
Focuses on strategies for clinical evaluation and their role in revealing the actual benefits and risks of medical innovation. Essays explore differences in current systems for developing and evaluating drugs, medical devices, and clinical procedures; the use of quality of life measures in clinical trials; health insurance databases as a tool for assessing treatment outcomes; and the role of the medical profession, the FDA, and industry in stimulating the use of evaluative methods throughout the different stages of the innovation spectrum. Annotation copyrighted by Book News, Inc., Portland, OR
Author: Yu-Kang Tu Publisher: Springer Science & Business Media ISBN: 9400730241 Category : Medical Languages : en Pages : 315
Book Description
Routine applications of advanced statistical methods on real data have become possible in the last ten years because desktop computers have become much more powerful and cheaper. However, proper understanding of the challenging statistical theory behind those methods remains essential for correct application and interpretation, and rarely seen in the medical literature. Modern Methods for Epidemiology provides a concise introduction to recent development in statistical methodologies for epidemiological and biomedical researchers. Many of these methods have become indispensible tools for researchers working in epidemiology and medicine but are rarely discussed in details by standard textbooks of biostatistics or epidemiology. Contributors of this book are experienced researchers and experts in their respective fields. This textbook provides a solid starting point for those who are new to epidemiology, and for those looking for guidance in more modern statistical approaches to observational epidemiology. Epidemiological and biomedical researchers who wish to overcome the mathematical barrier of applying those methods to their research will find this book an accessible and helpful reference for self-learning and research. This book is also a good source for teaching postgraduate students in medical statistics or epidemiology.
Author: Sandeep Menon Publisher: SAS Institute ISBN: 1629600849 Category : Computers Languages : en Pages : 364
Book Description
This book covers domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods applicable to and used in various phases of pharmaceutical development. Written for biostatisticians, pharmacometricians, clinical developers, and statistical programmers involved in the design, analysis, and interpretation of clinical trials, as well as students in graduate and postgraduate programs in statistics or biostatistics, it covers topics including: dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs incorporating historical data; adaptive sample size re-estimation and randomization to allocate subjects to effective treatments; population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology and rheumatology. --
Author: Kees van Montfort Publisher: Springer ISBN: 3642553451 Category : Mathematics Languages : en Pages : 361
Book Description
This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 9780309171144 Category : Medical Languages : en Pages : 222
Book Description
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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309044820 Category : Medical Languages : en Pages : 183
Book Description
The new Agency for Health Care Policy and Research in the U.S. Public Health Service is funding a set of multidisciplinary groups called Patient Outcomes Research Teams (PORTs). Their purpose is to assess alternative treatments for medical conditions using a variety of outcome measures. In guiding insurance coverage, these PORTs are expected to wield considerable influence on medical practice and health policy. This book addresses possible threats to their credibility that might be based on real or apparent conflicts of interest, including both financial and other conflicts. It raises points to consider for the new agency, for PORTs and their institutions, for industry, for the health services research community, and for the U.S. Congress in avoiding and managing conflicts of interest.
Author: George Thomas Lewith Publisher: Elsevier Health Sciences ISBN: 0702049166 Category : Medical Languages : en Pages : 426
Book Description
The use of complementary therapies is exploding, increasing the pressure to establish a rigorous science to support its practice. Clinical Research in Complementary Therapies: Principles, Problems and Solutions provides students with the tools they need to research complementary and integrative medicine (CIM) and so fill this gap. Essential for both undergraduate and postgraduate students, this second edition is significantly updated and enhanced. Part 1 deals with research strategies and methods, explaining the major types of clinical research in CIM and how these inter-relate. New chapters are included on whole systems research, qualitative research and questionnaire development. Not all therapies can be treated the same way nor channeled through the signal process of randomized controlled trials. Therefore, detailed description of mixed methods approaches including observational, qualitative, cost-benefit and comparative effectiveness research are described. Part 2 deals with specific complementary therapies and how they are invested by experts in each field. The book analyses the key questions asked and the controversies debated in complementary medicine research and offers clear and innovative guidance for answering these questions. FEATURES • Provides an overarching synthesis of methods in CIM and how they are to be used collectively including the role of comparative effectiveness research • Suggests both general and specific factors which need to be considered in assessing or planning complementary therapy research • Pinpoints aspects of research which are different in orthodox research and complementary therapy research • Reviews the types of research carried out in specific complementary therapies and analyses issues which arise • Includes information on measuring the economic cost and benefits of complementary medicine, clinical audit and the role of placebos use • Builds upon recent research results, looks at the lessons these provide for all complementary therapies and suggests key issues to address in future research. • Provides an overarching synthesis of methods in CIM and how they are to be used collectively including the role of comparative effectiveness research • Suggests both general and specific factors which need to be considered in assessing or planning complementary therapy research • Pinpoints aspects of research which are different in orthodox research and complementary therapy research • Reviews the types of research carried out in specific complementary therapies and analyses issues which arise • Includes information on measuring the economic cost and benefits of complementary medicine, clinical audit and the role of placebos use • Builds upon recent research results, looks at the lessons these provide for all complementary therapies and suggests key issues to address in future research.
Author: Institute of Medicine
Author: A.C. Gelijns
Author: Annetine C. Gelijns
Author: Yu-Kang Tu
Author: Rudy Capildeo
Author: Sandeep Menon
Author: Kees van Montfort
Author: Institute of Medicine
Author: Institute of Medicine
Author: George Thomas Lewith