Applied Statistical Considerations for Clinical Researchers

Applied Statistical Considerations for Clinical Researchers

Author: David Culliford

Publisher:

Published: 2022

Total Pages: 0

ISBN-13: 9783030874117

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This essential book details intermediate-level statistical methods and frameworks for the clinician and medical researcher with an elementary grasp of health statistics and focuses on selecting the appropriate statistical method for many scenarios. Detailed evaluation of various methodologies familiarizes readers with the available techniques and equips them with the tools to select the best from a range of options. The inclusion of a hypothetical case study between a clinician and statistician charting the conception of the research idea through to results dissemination enables the reader to understand how to apply the concepts covered into their day-to-day clinical practice. Applied Statistical Considerations for Clinical Researchers focuses on how clinicians can approach statistical issues when confronted with a medical research problem by considering the data structure, how this relates to their study's aims and any potential knock-on effects relating to the evidence required to make correct clinical decisions. It covers the application of intermediate-level techniques in health statistics making it an ideal resource for the clinician seeking an up-to-date resource on the topic.


Applied Statistical Considerations for Clinical Researchers

Applied Statistical Considerations for Clinical Researchers

Author: David Culliford

Publisher: Springer Nature

Published: 2021-11-18

Total Pages: 249

ISBN-13: 3030874109

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This essential book details intermediate-level statistical methods and frameworks for the clinician and medical researcher with an elementary grasp of health statistics and focuses on selecting the appropriate statistical method for many scenarios. Detailed evaluation of various methodologies familiarizes readers with the available techniques and equips them with the tools to select the best from a range of options. The inclusion of a hypothetical case study between a clinician and statistician charting the conception of the research idea through to results dissemination enables the reader to understand how to apply the concepts covered into their day-to-day clinical practice. Applied Statistical Considerations for Clinical Researchers focuses on how clinicians can approach statistical issues when confronted with a medical research problem by considering the data structure, how this relates to their study's aims and any potential knock-on effects relating to the evidence required to make correct clinical decisions. It covers the application of intermediate-level techniques in health statistics making it an ideal resource for the clinician seeking an up-to-date resource on the topic.


Design of Experiments and Advanced Statistical Techniques in Clinical Research

Design of Experiments and Advanced Statistical Techniques in Clinical Research

Author: Basavarajaiah D. M.

Publisher: Springer Nature

Published: 2020-11-05

Total Pages: 380

ISBN-13: 9811582106

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Recent Statistical techniques are one of the basal evidence for clinical research, a pivotal in handling new clinical research and in evaluating and applying prior research. This book explores various choices of statistical tools and mechanisms, analyses of the associations among different clinical attributes. It uses advanced statistical methods to describe real clinical data sets, when the clinical processes being examined are still in the process. This book also discusses distinct methods for building predictive and probability distribution models in clinical situations and ways to assess the stability of these models and other quantitative conclusions drawn by realistic experimental data sets. Design of experiments and recent posthoc tests have been used in comparing treatment effects and precision of the experimentation. This book also facilitates clinicians towards understanding statistics and enabling them to follow and evaluate the real empirical studies (formulation of randomized control trial) that pledge insight evidence base for clinical practices. This book will be a useful resource for clinicians, postgraduates scholars in medicines, clinical research beginners and academicians to nurture high-level statistical tools with extensive scope.


Common Statistical Methods for Clinical Research with SAS Examples, Third Edition

Common Statistical Methods for Clinical Research with SAS Examples, Third Edition

Author: Glenn Walker

Publisher: SAS Institute

Published: 2010-02-15

Total Pages: 553

ISBN-13: 1607644258

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Glenn Walker and Jack Shostak's Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, is a thoroughly updated edition of the popular introductory statistics book for clinical researchers. This new edition has been extensively updated to include the use of ODS graphics in numerous examples as well as a new emphasis on PROC MIXED. Straightforward and easy to use as either a text or a reference, the book is full of practical examples from clinical research to illustrate both statistical and SAS methodology. Each example is worked out completely, step by step, from the raw data. Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, is an applications book with minimal theory. Each section begins with an overview helpful to nonstatisticians and then drills down into details that will be valuable to statistical analysts and programmers. Further details, as well as bonus information and a guide to further reading, are presented in the extensive appendices. This text is a one-source guide for statisticians that documents the use of the tests used most often in clinical research, with assumptions, details, and some tricks--all in one place. This book is part of the SAS Press program.


Small Clinical Trials

Small Clinical Trials

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2001-01-01

Total Pages: 221

ISBN-13: 0309171148

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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.


Small Sample Size Solutions

Small Sample Size Solutions

Author: Rens van de Schoot

Publisher: Routledge

Published: 2020-02-13

Total Pages: 270

ISBN-13: 1000760944

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Researchers often have difficulties collecting enough data to test their hypotheses, either because target groups are small or hard to access, or because data collection entails prohibitive costs. Such obstacles may result in data sets that are too small for the complexity of the statistical model needed to answer the research question. This unique book provides guidelines and tools for implementing solutions to issues that arise in small sample research. Each chapter illustrates statistical methods that allow researchers to apply the optimal statistical model for their research question when the sample is too small. This essential book will enable social and behavioral science researchers to test their hypotheses even when the statistical model required for answering their research question is too complex for the sample sizes they can collect. The statistical models in the book range from the estimation of a population mean to models with latent variables and nested observations, and solutions include both classical and Bayesian methods. All proposed solutions are described in steps researchers can implement with their own data and are accompanied with annotated syntax in R. The methods described in this book will be useful for researchers across the social and behavioral sciences, ranging from medical sciences and epidemiology to psychology, marketing, and economics.


Understanding Clinical Data Analysis

Understanding Clinical Data Analysis

Author: Ton J. Cleophas

Publisher: Springer

Published: 2016-08-23

Total Pages: 241

ISBN-13: 3319395866

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This textbook consists of ten chapters, and is a must-read to all medical and health professionals, who already have basic knowledge of how to analyze their clinical data, but still, wonder, after having done so, why procedures were performed the way they were. The book is also a must-read to those who tend to submerge in the flood of novel statistical methodologies, as communicated in current clinical reports, and scientific meetings. In the past few years, the HOW-SO of current statistical tests has been made much more simple than it was in the past, thanks to the abundance of statistical software programs of an excellent quality. However, the WHY-SO may have been somewhat under-emphasized. For example, why do statistical tests constantly use unfamiliar terms, like probability distributions, hypothesis testing, randomness, normality, scientific rigor, and why are Gaussian curves so hard, and do they make non-mathematicians getting lost all the time? The book will cover the WHY-SOs.


Statistical Issues in Drug Development

Statistical Issues in Drug Development

Author: Stephen S. Senn

Publisher: John Wiley & Sons

Published: 2008-02-28

Total Pages: 523

ISBN-13: 9780470723579

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Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and interpretation ofclinical trials. Expanded sections on missing data, equivalence, meta-analysisand dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage ofpharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9,Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue betweenstatisticians and life scientists working within the pharmaceuticalindustry. The accessible and wide-ranging coverage make itessential reading for both statisticians and non-statisticiansworking in the pharmaceutical industry, regulatory bodies andmedical research institutes. There is also much to benefitundergraduate and postgraduate students whose courses include amedical statistics component.


Cross-over Trials in Clinical Research

Cross-over Trials in Clinical Research

Author: Stephen S. Senn

Publisher: John Wiley & Sons

Published: 2003-07-25

Total Pages: 364

ISBN-13: 0470854588

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Cross-over trials are an important class of design used in the pharmaceutical industry and medical research, and their use continues to grow. Cross-over Trials in Clinical Research, Second Edition has been fully updated to include the latest methodology used in the design and analysis of cross-over trials. It includes more background material, greater coverage of important statistical techniques, including Bayesian methods, and discussion of analysis using a number of statistical software packages. * Comprehensive coverage of the design and analysis of cross-over trials. * Each technique is carefully explained and the mathematics is kept to a minimum. * Features many real and original examples, taken from the author's vast experience. * Includes discussion of analysis using SAS, S-Plus and, GenStat, StatXact and Excel. * Written in a style suitable for statisticians and physicians alike. * Computer programs to accompany the examples in the book can be downloaded from the Web Primarily aimed at statisticians and researchers working in the pharmaceutical industry, the book will also appeal to physicians involved in clinical research and students of medical statistics.


Statistical Methods in Psychiatry and Related Fields

Statistical Methods in Psychiatry and Related Fields

Author: Ralitza Gueorguieva

Publisher: CRC Press

Published: 2020-09-30

Total Pages: 352

ISBN-13: 9780367657529

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Data collected in psychiatry and related fields are complex because outcomes are rarely directly observed, there are multiple correlated repeated measures within individuals, there is natural heterogeneity in treatment responses and in other characteristics in the populations. Simple statistical methods do not work well with such data. More advanced statistical methods capture the data complexity better, but are difficult to apply appropriately and correctly by investigators who do not have advanced training in statistics. This book presents, at a non-technical level, several approaches for the analysis of correlated data: mixed models for continuous and categorical outcomes, nonparametric methods for repeated measures and growth mixture models for heterogeneous trajectories over time. Separate chapters are devoted to techniques for multiple comparison correction, analysis in the presence of missing data, adjustment for covariates, assessment of mediator and moderator effects, study design and sample size considerations. The focus is on the assumptions of each method, applicability and interpretation rather than on technical details. Features Provides an overview of intermediate to advanced statistical methods applied to psychiatry. Takes a non-technical approach with mathematical details kept to a minimum. Includes lots of detailed examples from published studies in psychiatry and related fields. Software programs, data sets and output are available on a supplementary website. The intended audience are applied researchers with minimal knowledge of statistics, although the book could also benefit collaborating statisticians. The book, together with the online materials, is a valuable resource aimed at promoting the use of appropriate statistical methods for the analysis of repeated measures data. Ralitza Gueorguieva is a Senior Research Scientist at the Department of Biostatistics, Yale School of Public Health. She has more than 20 years experience in statistical methodology development and collaborations with psychiatrists and other researchers, and is the author of over 130 peer-reviewed publications.