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A Comprehensive and Practical Guide to Clinical Trials

A Comprehensive and Practical Guide to Clinical Trials
A Book

by Delva Shamley,Brenda Wright

  • Publisher : Academic Press
  • Release : 2017-06-07
  • Pages : 210
  • ISBN : 0128047305
  • Language : En, Es, Fr & De
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A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. Describes the entire clinical trial management process from start to finish in a step-by-step guide Provides best practice elements, including case studies, practical examples, activities, and checklists Accompanied by a website with PowerPoint slides and an image bank

A Practical Guide to Managing Clinical Trials

A Practical Guide to Managing Clinical Trials
A Book

by JoAnn Pfeiffer,Cris Wells

  • Publisher : CRC Press
  • Release : 2017-05-18
  • Pages : 256
  • ISBN : 1315299771
  • Language : En, Es, Fr & De
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A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

The Comprehensive Guide To Clinical Research

The Comprehensive Guide To Clinical Research
A Practical Handbook For Gaining Insight Into The Clinical Research Industry

by Chris Sauber,Dan Sfera

  • Publisher : Independently Published
  • Release : 2019-04-21
  • Pages : 218
  • ISBN : 9781090349521
  • Language : En, Es, Fr & De
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Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps

Phase I Cancer Clinical Trials

Phase I Cancer Clinical Trials
A Practical Guide

by Elizabeth A. Eisenhauer,Christopher Twelves,Marc Buyse

  • Publisher : Oxford University Press
  • Release : 2015-03-20
  • Pages : 352
  • ISBN : 0199359032
  • Language : En, Es, Fr & De
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Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. Their primary goals are to identify the recommended dose, schedule and pharmacologic behavior of new agents or new combinations of agents and to describe the adverse effects of treatment. In cancer therapeutics, such studies have particular challenges. Due to the nature of the effects of treatment, most such studies are conducted in patients with advanced malignancy, rather than in healthy volunteers. Further, the endpoints of these trials are usually measures adverse effects rather than molecular target or anti-tumor effects. These factors render the design, conduct, analysis and ethical aspects of phase I cancer trials unique. As the only comprehensive book on this topic, Phase I Cancer Clinical Trials is a useful resource for oncology trainees or specialists interested in understanding cancer drug development. New to this edition are chapters on Phase 0 Trials and Immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials

Practical Guide to Clinical Data Management, Third Edition

Practical Guide to Clinical Data Management, Third Edition
A Book

by Susanne Prokscha

  • Publisher : CRC Press
  • Release : 2011-10-26
  • Pages : 296
  • ISBN : 1439848319
  • Language : En, Es, Fr & De
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The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture (EDC) for most studies. See what’s new in the Third Edition: A chapter on the clinical trial process that explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow Reorganized content reflects an industry trend that divides training and standard operating procedures for clinical data management into the categories of study startup, study conduct, and study closeout Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns The book provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks. It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance. Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers.

Clinical Trials

Clinical Trials
A Practical Guide to Design, Analysis, and Reporting

by Duolao Wang,Ameet Bakhai

  • Publisher : Remedica
  • Release : 2006
  • Pages : 480
  • ISBN : 1901346722
  • Language : En, Es, Fr & De
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This book 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 Sourcebook for Clinical Research

The Sourcebook for Clinical Research
A Practical Guide for Study Conduct

by Natasha Martien,Jeff Nelligan

  • Publisher : Academic Press
  • Release : 2018-08-01
  • Pages : 274
  • ISBN : 0128162430
  • Language : En, Es, Fr & De
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A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website (https://www.elsevier.com/books-and-journals/book-companion/9780128162422), so that study teams will be compliant and will find all the necessary tools within this book. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic. Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP) Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research process Provides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately. Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject’s needs urgently and compliantly

A Concise Guide to Clinical Trials

A Concise Guide to Clinical Trials
A Book

by Allan Hackshaw

  • Publisher : John Wiley & Sons
  • Release : 2011-09-07
  • Pages : 224
  • ISBN : 1444356666
  • Language : En, Es, Fr & De
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Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations. This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at: Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials Health professionals who wish to conduct their own trials, or participate in other people’s studies People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies

Analyzing Longitudinal Clinical Trial Data

Analyzing Longitudinal Clinical Trial Data
A Practical Guide

by Craig Mallinckrodt,Ilya Lipkovich

  • Publisher : CRC Press
  • Release : 2016-12-12
  • Pages : 302
  • ISBN : 1351737694
  • Language : En, Es, Fr & De
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Analyzing Longitudinal Clinical Trial Data: A Practical Guide provides practical and easy to implement approaches for bringing the latest theory on analysis of longitudinal clinical trial data into routine practice.The book, with its example-oriented approach that includes numerous SAS and R code fragments, is an essential resource for statisticians and graduate students specializing in medical research. The authors provide clear descriptions of the relevant statistical theory and illustrate practical considerations for modeling longitudinal data. Topics covered include choice of endpoint and statistical test; modeling means and the correlations between repeated measurements; accounting for covariates; modeling categorical data; model verification; methods for incomplete (missing) data that includes the latest developments in sensitivity analyses, along with approaches for and issues in choosing estimands; and means for preventing missing data. Each chapter stands alone in its coverage of a topic. The concluding chapters provide detailed advice on how to integrate these independent topics into an over-arching study development process and statistical analysis plan.

Clinical Trials and Human Research

Clinical Trials and Human Research
A Practical Guide to Regulatory Compliance

by Fay A. Rozovsky, JD, MPH,Rodney K. Adams

  • Publisher : Jossey-Bass
  • Release : 2003-06-10
  • Pages : 656
  • ISBN : 9780787965709
  • Language : En, Es, Fr & De
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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.

Clinical Studies Management

Clinical Studies Management
A Practical Guide to Success

by Simon Cook

  • Publisher : CRC Press
  • Release : 2004-01-15
  • Pages : 128
  • ISBN : 9781135490577
  • Language : En, Es, Fr & De
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What if you were suddenly in charge? After the initial excitement of a "battlefield promotion" wears off, you need to get in the trenches and get the job done. And if you are already in the trenches, you need quick access to information that will make your job easier. A comprehensive desk reference and guide, Clinical Studies Management: A Practical Guide to Success provides the practical skills and methods required by project managers running clinical studies. The author explains a framework for project management based on seven core themes: goals, budgets, time, resources, measurement, communication, and training. He solidly reviews how modern management theory can be brought to bear on the specialized demands of clinical trials. The book covers the practical how-tos of writing and costing a study, organizing an Investigator Meeting, and improving patient enrollment in your study. Divided into stand-alone chapters that make the information easy to find, the book presents a comprehensive overview of drug development processes and the trends that are driving change. If you are new to study management, the book rapidly brings you up to speed. If you are an experienced study manager, it gives you a convenient and authoritative reference you will use on a daily basis. Whatever your level of experience, Clinical Studies Management: A Practical Guide to Success supplies the tools you need to manage your projects efficiently and effectively.

A Practical Guide to Designing Phase II Trials in Oncology

A Practical Guide to Designing Phase II Trials in Oncology
A Book

by Sarah R. Brown,Walter M. Gregory,Christopher J. Twelves,Julia M. Brown

  • Publisher : John Wiley & Sons
  • Release : 2014-03-28
  • Pages : 256
  • ISBN : 1118763637
  • Language : En, Es, Fr & De
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How to identify optimal phase II trial designs Providing a practical guide containing the information needed to make crucial decisions regarding phase II trial designs, A Practical Guide to Designing Phase II Trials in Oncology sets forth specific points for consideration between the statistician and clinician when designing a phase II trial, including issues such as how the treatment works, choice of outcome measure and randomization, and considering both academic and industry perspectives. A comprehensive and systematic library of available phase II trial designs is included, saving time otherwise spent considering multiple manuscripts, and real-life practical examples of using this approach to design phase II trials in cancer are given. A Practical Guide to Designing Phase II Trials in Oncology: Offers a structured and practical approach to phase II trial design Considers trial design from both an academic and industry perspective Includes a structured library of available phase II trial designs Is relevant to both clinical and statistical researchers at all levels Includes real life examples of applying this approach For those new to trial design, A Practical Guide to Designing Phase II Trials in Oncology will be a unique and practical learning tool, providing an introduction to the concepts behind informed decision making in phase II trials. For more experienced practitioners, the book will offer an overview of new, less familiar approaches to phase II trial design, providing alternative options to those which they may have previously used.

Preventing and Treating Missing Data in Longitudinal Clinical Trials

Preventing and Treating Missing Data in Longitudinal Clinical Trials
A Practical Guide

by Craig H. Mallinckrodt

  • Publisher : Cambridge University Press
  • Release : 2013-01-28
  • Pages : 329
  • ISBN : 1107311365
  • Language : En, Es, Fr & De
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Recent decades have brought advances in statistical theory for missing data, which, combined with advances in computing ability, have allowed implementation of a wide array of analyses. In fact, so many methods are available that it can be difficult to ascertain when to use which method. This book focuses on the prevention and treatment of missing data in longitudinal clinical trials. Based on his extensive experience with missing data, the author offers advice on choosing analysis methods and on ways to prevent missing data through appropriate trial design and conduct. He offers a practical guide to key principles and explains analytic methods for the non-statistician using limited statistical notation and jargon. The book's goal is to present a comprehensive strategy for preventing and treating missing data, and to make available the programs used to conduct the analyses of the example dataset.

Clinical Trial Registries

Clinical Trial Registries
A Practical Guide for Sponsors and Researchers of Medicinal Products

by MaryAnn Foote

  • Publisher : Springer Science & Business Media
  • Release : 2006-11-09
  • Pages : 194
  • ISBN : 3764375833
  • Language : En, Es, Fr & De
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ICMJE editors and other journal editors require registration of clinical trial information on publicly available Web sites before enrollment of study subjects. Not only does this book discuss the genesis of these requirements, it also provides practical information for researchers and sponsors on how to establish a workflow for a clinical registry project, how to file to a registry, and how to post results.

Clinical Trials

Clinical Trials
A Practical Approach

by Stuart J. Pocock

  • Publisher : John Wiley & Sons
  • Release : 2013-07-17
  • Pages : 288
  • ISBN : 1118794109
  • Language : En, Es, Fr & De
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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.

Clinical Research Manual

Clinical Research Manual
Practical Tools and Templates for Managing Clinical Research

by Ruth Jennifer Cavalieri,Mark E. Rupp

  • Publisher : Sigma Theta Tau
  • Release : 2013-06-17
  • Pages : 262
  • ISBN : 1937554635
  • Language : En, Es, Fr & De
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Clinical Research Manual: Practical Tools and Templates for Managing Clinical Research is the "must-have" book for anyone working in the day-to-day operations of a research study or clinical trial. Filled with tools, techniques, and templates, this manual offers clinical researchers, principal investigators, and research coordinators the foundation they need to successfully organize complex trials.

Management of Data in Clinical Trials

Management of Data in Clinical Trials
A Book

by Eleanor McFadden

  • Publisher : John Wiley & Sons
  • Release : 2007-12-14
  • Pages : 288
  • ISBN : 9780470181270
  • Language : En, Es, Fr & De
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A valuable new edition of the trusted, practical guide to managing data in clinical trials Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided. While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements. Newly featured topics include: The growing availability of "off-the-shelf" solutions for clinical trials Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry The increasing use of the Internet in the collection of data and management of trials Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines Development of Standard Operating Procedures for the conduct of clinical trials Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.

Practical Guide to the Evaluation of Clinical Competence

Practical Guide to the Evaluation of Clinical Competence
A Book

by Eric S. Holmboe,Steven J. Durning,Richard E. Hawkins

  • Publisher : Unknown Publisher
  • Release : 2017-05-01
  • Pages : 368
  • ISBN : 9780323447348
  • Language : En, Es, Fr & De
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Designed to help medical educators implement better assessment methods, tools, and models directly into training programs, Practical Guide to the Evaluation of Clinical Competence, 2nd Edition, by Drs. Eric S. Holmboe, Steven J. Durning, and Richard E. Hawkins, is a hands-on, authoritative guide to outcomes-based assessment in clinical education. National and international experts present an organized, multifaceted approach and a diverse combination of methods to help you perform effective assessments. This thoroughly revised edition is a valuable resource for developing, implementing, and sustaining effective systems for evaluating clinical competence in medical school, residency, and fellowship programs.

Clinical Trials

Clinical Trials
Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

by Tom Brody

  • Publisher : Academic Press
  • Release : 2011-10-25
  • Pages : 638
  • ISBN : 0123919134
  • Language : En, Es, Fr & De
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Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design. Provides extensive coverage of the "study schema" and related features of study design Offers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials Includes chapters on core material and important ancillary topics, such as package inserts, consent forms, and safety reporting forms used in the United States, England and Europe For complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser: http://tinyurl.com/awwutvn

Missing Data in Clinical Studies

Missing Data in Clinical Studies
A Book

by Geert Molenberghs,Michael Kenward

  • Publisher : John Wiley & Sons
  • Release : 2007-04-04
  • Pages : 526
  • ISBN : 9780470510438
  • Language : En, Es, Fr & De
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Missing Data in Clinical Studies provides a comprehensive account of the problems arising when data from clinical and related studies are incomplete, and presents the reader with approaches to effectively address them. The text provides a critique of conventional and simple methods before moving on to discuss more advanced approaches. The authors focus on practical and modeling concepts, providing an extensive set of case studies to illustrate the problems described. Provides a practical guide to the analysis of clinical trials and related studies with missing data. Examines the problems caused by missing data, enabling a complete understanding of how to overcome them. Presents conventional, simple methods to tackle these problems, before addressing more advanced approaches, including sensitivity analysis, and the MAR missingness mechanism. Illustrated throughout with real-life case studies and worked examples from clinical trials. Details the use and implementation of the necessary statistical software, primarily SAS. Missing Data in Clinical Studies has been developed through a series of courses and lectures. Its practical approach will appeal to applied statisticians and biomedical researchers, in particular those in the biopharmaceutical industry, medical and public health organisations. Graduate students of biostatistics will also find much of benefit.