Statistical concepts provide scientific framework in experimental studies, including randomized controlled trials. In order to design, monitor, analyze and draw conclusions scientifically from such clinical trials, clinical investigators and statisticians should have a firm grasp of the requisite statistical concepts. The Handbook of Statistical Methods for Randomized Controlled Trials presents these statistical concepts in a logical sequence from beginning to end and can be used as a textbook in a course or as a reference on statistical methods for randomized controlled trials. Part I provides a brief historical background on modern randomized controlled trials and introduces statistical concepts central to planning, monitoring and analysis of randomized controlled trials. Part II describes statistical methods for analysis of different types of outcomes and the associated statistical distributions used in testing the statistical hypotheses regarding the clinical questions. Part III describes some of the most used experimental designs for randomized controlled trials including the sample size estimation necessary in planning. Part IV describe statistical methods used in interim analysis for monitoring of efficacy and safety data. Part V describe important issues in statistical analyses such as multiple testing, subgroup analysis, competing risks and joint models for longitudinal markers and clinical outcomes. Part VI addresses selected miscellaneous topics in design and analysis including multiple assignment randomization trials, analysis of safety outcomes, non-inferiority trials, incorporating historical data, and validation of surrogate outcomes.

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.

1. Provides a comprehensive overview of meta-analysis methods and applications. 2. Divided into four major sub-topics, covering univariate meta-analysis, multivariate, applications and policy. 3. Designed to be suitable for graduate students and researchers new to the field. 4. Includes lots of real examples, with data and software code made available. 5. Chapters written by the leading researchers in the field.

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

Evidence from randomized controlled clinical trials is widely accepted as the only sound basis for assessing the efficacy of new medical treatments. Statistical methods play a key role in all stages of these trials, including their justification, design, and analysis. This second edition of Introduction to Randomized Controlled Clinical Trials prov

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.

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

A Proven Guide for Easily Using R to Effectively Analyze Data Like its bestselling predecessor, A Handbook of Statistical Analyses Using R, Second Edition provides a guide to data analysis using the R system for statistical computing. Each chapter includes a brief account of the relevant statistical background, along with appropriate references. New to the Second Edition New chapters on graphical displays, generalized additive models, and simultaneous inference A new section on generalized linear mixed models that completes the discussion on the analysis of longitudinal data where the response variable does not have a normal distribution New examples and additional exercises in several chapters A new version of the HSAUR package (HSAUR2), which is available from CRAN This edition continues to offer straightforward descriptions of how to conduct a range of statistical analyses using R, from simple inference to recursive partitioning to cluster analysis. Focusing on how to use R and interpret the results, it provides students and researchers in many disciplines with a self-contained means of using R to analyze their data.

This volume, representing a compilation of authoritative reviews on a multitude of uses of statistics in epidemiology and medical statistics written by internationally renowned experts, is addressed to statisticians working in biomedical and epidemiological fields who use statistical and quantitative methods in their work. While the use of statistics in these fields has a long and rich history, explosive growth of science in general and clinical and epidemiological sciences in particular have gone through a see of change, spawning the development of new methods and innovative adaptations of standard methods. Since the literature is highly scattered, the Editors have undertaken this humble exercise to document a representative collection of topics of broad interest to diverse users. The volume spans a cross section of standard topics oriented toward users in the current evolving field, as well as special topics in much need which have more recent origins. This volume was prepared especially keeping the applied statisticians in mind, emphasizing applications-oriented methods and techniques, including references to appropriate software when relevant.· Contributors are internationally renowned experts in their respective areas· Addresses emerging statistical challenges in epidemiological, biomedical, and pharmaceutical research· Methods for assessing Biomarkers, analysis of competing risks· Clinical trials including sequential and group sequential, crossover designs, cluster randomized, and adaptive designs· Structural equations modelling and longitudinal data analysis

"an ideal set text" Angela Scriven, Course Leader, Brunel University Which research method should I use to evaluate services? How do I design a questionnaire? How do I conduct a systematic review of research? This handbook helps researchers to plan, carry out, and analyse health research, and evaluate the quality of research studies. The book takes a multidisciplinary approach to enable researchers from different disciplines to work side-by-side in the investigation of population health, the evaluation of health care, and in health care delivery. Handbook of Health Research Methods is an essential tool for researchers and postgraduate students taking masters courses, or undertaking doctoral programmes, in health services evaluation, health sciences, health management, public health, nursing, sociology, socio-biology, medicine and epidemiology. However, the book also appeals to health professionals who wish to broaden their knowledge of research methods in order to make effective policy and practice decisions. Contributors: Joy Adamson, Geraldine Barrett, Jane P. Biddulph, Ann Bowling, Sara Brookes, Jackie Brown, Simon Carter, Michel P. Coleman, Paul Cullinan, George Davey Smith, Paul Dieppe, Jenny Donovan, Craig Duncan, Shah Ebrahim, Vikki Entwistle, Clare Harries, Lesley Henderson, Kelvyn Jones, Olga Kostopoulou, Sarah J. Lewis, Richard Martin, Martin McKee, Graham Moon, Ellen Nolte, Alan O’Rourke, Ann Oakley, Tim Peters, Tina Ramkalawan, Caroline Sanders, Mary Shaw, Andrew Steptoe, Jonathan Sterne, Anne Stiggelbout, S.V. Subramanian, Kate Tilling, Liz Twigg, Suzanne Wait.