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Design and Analysis of Group- Randomized Trials Description

This text provides the most comprehensive treatment of the design and analytic issues involved in group-randomized trials. GRTs are comparative studies conducted to evaluate the effect of a health promotion intervention in which the units of assignment are identifiable groups (e.g., schools, worksites) and the units of observation are members of those groups (e.g., students, workers). The book reviews the underlying issues, the most widely used research designs, and analytic strategies. There is an emphasis on mixed-model regression, with two chapters illustrating the analytic methods in SAS PROC MIXED and GLIMMIX. There is also a detailed chapter on power analysis and sample size calculation.

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There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities.
* Provides a practical overview of data monitoring in clinical trials.
* Describes the purpose, responsibilities and operation of data monitoring committees.
* Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees.
* Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees.
* Discusses issues pertinent to those working in clinical trials in both the US and Europe.
The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.

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Drawing on various real-world applications, Sample Sizes for Clinical Trials takes readers through the process of calculating sample sizes for many types of clinical trials. It provides descriptions of the calculations with a practical emphasis.

Focusing on normal, binary, ordinal, and survival data, the book explores a range of trials, including superiority, equivalence, non-inferiority, bioequivalence, and precision for both parallel group and crossover designs. The author discusses how trial objectives impact the study design with respect to the derivation of formulae for sample size calculations. He uses real-life studies throughout to show how the concepts and calculations can be employed.

This work underscores the importance of sample size calculation in the design of a clinical trial. With useful calculation tables throughout, it enables readers to quickly find an appropriate formula, formula application, and associated worked example.

Watch the author speak about this book at JSM 2012 in San Diego.

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This book is a friendly jargon buster, which aims to demystify clinical trials. It is divided into five sections: fundamentals of trial design, alternative trial designs, basics of statistical analysis, special trial issues in data analysis, and reporting of trials. Using simple language the book explains with illustrations of numerous trial examples, the conceptual and methodological issues that occur at all stages of clinical trial covering trial design, conduct, analysis and reporting. The book is an educational and approachable reference in a difficult area of medicine where clinicians often feel uncertain and this material helps them review, appraise and publish trials and clinical evidence. The audience for the book includes physicians, statisticians, pharmacists, medical students, clinical researchers, medical writers, data managers, study co-ordinators, pharmaceutical sales representatives, and financial (medical) analysts.

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When Experiments Travel: Clinical Trials and the Global Search for Human Subjects

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The phenomenal growth of global pharmaceutical sales and the quest for innovation are driving an unprecedented search for human test subjects, particularly in middle- and low-income countries. Our hope for medical progress increasingly depends on the willingness of the world's poor to participate in clinical drug trials. While these experiments often provide those in need with vital and previously unattainable medical resources, the outsourcing and offshoring of trials also create new problems. In this groundbreaking book, anthropologist Adriana Petryna takes us deep into the clinical trials industry as it brings together players separated by vast economic and cultural differences. Moving between corporate and scientific offices in the United States and research and public health sites in Poland and Brazil, When Experiments Travel documents the complex ways that commercial medical science, with all its benefits and risks, is being integrated into local health systems and emerging drug markets.

Providing a unique perspective on globalized clinical trials, When Experiments Travel raises central questions: Are such trials exploitative or are they social goods? How are experiments controlled and how is drug safety ensured? And do these experiments help or harm public health in the countries where they are conducted? Empirically rich and theoretically innovative, the book shows that neither the language of coercion nor that of rational choice fully captures the range of situations and value systems at work in medical experiments today. When Experiments Travel challenges conventional understandings of the ethics and politics of transnational science and changes the way we think about global medicine and the new infrastructures of our lives.

Design and Analysis of Cluster Randomization Trials in Health Research Shopping

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A cluster randomization trial is one in which intact social units, or clusters of individuals, are randomized to different intervention groups. Trials randomizing clusters have become particularly widespread in the evaluation of non-therapeutic interventions, including lifestyle modification, educational programmes and innovations in the provision of health care. The increasing popularity of this design among health researchers over the past two decades has led to an extensive body of methodology on the subject. This is the first book to present a systematic and united treatment of this topic; it contains distinctive chapters on the history of cluster randomized trials, ethical issues and reporting guidelines.

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Buy Selection Bias and Covariate Imbalances in Randomized Clinical Trials (Statistics in Practice)

Selection Bias and Covariate Imbalances in Randomized Clinical Trials (Statistics in Practice) by Wiley




Selection bias can, and does, occur, even in randomized clinical trials. Steps need to be taken in order to ensure that this does not compromise the integrity of clinical trials; hence “Selection Bias and Covariate Imbalances in Randomized Clinical Trials" offers a comprehensive treatment of the subject and the methodology involved.  This book:

• Provides an overview of the hierarchy of study designs, and justifies the position of randomised trials at the top of this hierarchy.
• Discusses the strengths and defects of randomisation, and provides real evidence to justify concern regarding its defects.
• Outlays the damaging consequences that selection bias causes when it does occur.
• Considers courses of action that can be taken to manage/ contain the problem.
• Presents methods that can be used to detect selection bias in randomised trials, and methods to correct for selection bias.
• Concludes by providing a comprehensive plan for managing baseline imbalances and selection bias in randomised trials, and proposing open problems for future research.

 Illustrated with case studies, this book introduces groundbreaking ideas and research that will be invaluable to researchers and practitioners who design and analyse clinical trials. It will also be of interest to graduate students within the field of biostatistics. Read more Selection Bias and Covariate Imbalances in Randomized Clinical Trials (Statistics in Practice)

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+++ Clinical Trials Handbook: Design and Conduct save

Clinical Trials Handbook: Design and Conduct

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A systematic approach to all aspects of designing and conducting clinical trials

The success or failure of clinical trials hinges on hundreds of details that need to be developed, often under less than ideal conditions. Written by one of the world's leading trialists, Clinical Trials Handbook: Design and Conduct provides clinicians with a complete guide to designing, conducting, and evaluating clinical trials—teaching them how to simplify the process and avoid costly mistakes.

The author draws on his extensive clinical trials experience to outline all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. Along the way, practical advice is offered while also addressing a mix of logistical, ethical, psychological, behavioral, and administrative issues inherent to clinical trials. Topics of coverage include:

• Protocols for drug masking, controls, and treatment randomization
• Consent, enrollment, eligibility, and follow-up procedures
• Different types of sample size design and data collection and processing
• Working with study centers, research staff, and various committees
• Monitoring treatment effects and performance, and ensuring quality control
• Data analysis and access policies for study data and documents

Clinical Trials Handbook is invaluable for practicing clinicians and trialists who would like to learn more about or improve their understanding of the design and execution of clinical trials. The book is also an excellent supplement for courses on clinical trials at the graduate level.

****** Best Revews Strategy and Statistics in Clinical Trials: A non-statisticians guide to thinking, designing and executing

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Strategy and Statistics in Clinical Trials: A non-statisticians guide to thinking, designing and executing Description

Strategy and Statistics in Clinical Trials is for all individuals engaged in clinical research, including professors, physicians, researchers in corporate and government laboratories, nurses, members of the allied health professions, and post-doctoral and graduate students who are potentially less exposed to understanding the pivotal role of statistics.

. Enables nonstatisticians to better understand research processes and statistics' role in these processes . Offers real-life case studies and provides a practical, "how to" guide to biomedical R&D . Delineates the statistical building blocks and concepts of clinical trials . Promotes effective cooperation between statisticians and important other parties

****** Physician Investigator Handbook: GCP Tools and Techniques, Second Edition (Practical Clinical Trials Series)

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Physician Investigator Handbook: GCP Tools and Techniques, Second Edition (Practical Clinical Trials Series) Description

A comprehensive guide for physicians conducting clinical research, this second edition addresses a broader research perspective. It includes information on the implications of the ICH Guidelines, current FDA regulations, and an Internet address directory. Everything the clinical trial manager, planner, monitor, and investigator need to know about the design, establishment, monitoring, and close-out of a trial is in this book. The chapters address the elements of clinical research, professional interactions, FDA regulations and good clinical practices guidelines, investigational agent management, designing a study and protocol development, conducting the study, and more.

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This book presents a logical system of critical appraisal, to allow readers to evaluate studies and to carry out their own studies more effectively. This system emphasizes the central importance of cause and effect relationships. Its great strength is that it is applicable to a wide range of issues, and both to intervention trials and observational studies.

This system unifies the often different approaches used in epidemiology, health services research, clinical trials, and evidence-based medicine, starting from a logical consideration of cause and effect. The author's approach to the issues of study design, selection of subjects, bias, confounding, and the place of statistical methods has been praised for its clarity and interest. Systematic reviews, meta-analysis, and the applications of this logic to evidence-based medicine, knowledge-based health care, and health practice and policy are discussed. Current and often controversial examples are used, including screening for prostate cancer, publication bias in psychiatry, public health issues in developing countries, and conflicts between observational studies and randomized trials. Statistical issues are explained clearly without complex mathematics, and the most useful methods are summarized in the appendix.

The final chapters give six applications of the critical appraisal of major studies; randomized trials of medical treatment and prevention, a prospective and a retrospective cohort study, a small matched case-control study, and a large case-control study. In these chapters, sections of the original papers are reproduced and the original studies places in context by a summary of current developments.

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The definitive reference work on clinical trials, this book presents a wealth of detailed, practical information on the design, conduct and analysis of both single centre and multicentre trials.

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Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance Shopping

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This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.

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Best Designing Randomised Trials in Health, Education and the Social Sciences: An Introduction

Designing Randomised Trials in Health, Education and the Social Sciences: An Introduction by Palgrave Macmillan

Policy makers are increasingly demanding evidence from randomized trials. The book focuses on the design of rigorous trials rather than their statistical underpinnings or analyses. Consequently, statistical theory is absent and statistical methods are minimal. Few other texts go into such detailed description about randomization procedures and different trial designs within the same volume. The book has chapters on: pragmatic designs; placebo designs; preference approaches; unequal allocation; economics; analytical approaches; randomization methods.

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The randomized control clinical trial has become the gold standard scientific method for the evaluation of pharmaceuticals, biologics, devices, procedures and diagnostic tests. This trial design has been successfully used in both therapeutic and disease prevention trials. It is superior to alternative designs by eliminating several sources of bias which exist in those designs. This role has evolved over the past three decades in a number of disease areas including cardiology, opthalmology, cancer and AIDS. While the specifics of using the randomized control design for a specific intervention and disease may differ, the basic fundamentals still apply in developing the study protocol and operational procedures. These fundamentals still apply in developing the study protocol and operational procedures. These fundamentals include identifying the specific questions to be tested and appropriate outcome measures, determining an adequate sample size, specifying the randomization procedure, detailing the intervention with visit schedules for subject evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and determining the organizational structure. This text is structured to address the fundamentals as the protocol for a clinical trial is being developed. A chapter is devoted to each of the critical areas of a protocol to aid the clinical trial researcher. The fundamentals described in this text are based on sound scientific methodology, statistical principles and years of accumulated experience by the three authors. Collectively, the authors have been active researchers in a broad area of clinical trials including cardiology, cancer, opthalmology, diabetes, osteoporosis, AIDS, women's health and screening tests. In these studies, the authors have served as members of the steering committee responsible for developing the protocol and as members of data and safety monitoring committees. The fundamentals were proposed in the first edition published in 1981 and have not changed substantially in the later editions. However, the number of examples illustrating the fundamentals has greatly expanded base on the collective experience of the authors. This text is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The test uses numerous examples of published clinical trials from a variety of medical disciples to meaningfully illustrate the fundamentals. Technical design issues such as sample size are considered but the technical details have been suppressed as much as possible through the use of graphs and tables. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful both in a consulting and teaching capacity. The text assumes that the readers have only a modest formal statistical background. A basic introductory statistics course is helpful in maximizing the benefit of the text. However, a researcher or practitioner with no statistical background would still find most, if not all the chapters understandable and useful.

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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.

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