Sample Sizes for Clinical Trials

With worked examples and problems based on real-world scenarios, this book takes readers through the process of calculating the sample size for many types of clinical trials. It covers the most common types of clinical trials across all phases. The author discusses how assumptions made in a sample size calculation can impact the calculation. He provides calculations for many of the trials and offers hints and tips on how to optimize the calculations. He also illustrates the steps involved in determining sample size, from defining the trial objective to selecting an appropriate endpoint.

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Preclinical Drug Development, Second Edition

Preclinical Drug Development, Second Edition discusses the broad realm of preclinical drug development, ranging from assessment of pharmacology and toxicology to the industry trends and regulatory expectations and requirements that support clinical trials. This guide is a fundamental resource for medicinal chemists, biologists, and other specialists in the drug development sciences.

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Dictionary for Clinical Trials

As a result of the expansion in the area of pharmaceutical medicine there is an ever-increasing need for educational resources. The Dictionary of Clinical Trials, Second Edition comprehensively explains the 3000 words and short phrases commonly used when designing, running, analysing and reporting clinical trials.

This book is a quick, pocket reference tool to understand the common and less well-used terms within the discipline of clinical trials, and provides an alternative to the textbooks available. Terms are heavily cross-referenced, which helps the reader to understand how terms fit into the broad picture of clinical trials.

Wide ranging, brief, pragmatic explanations of clinical trial terminology

Scope includes medical, statistical, epidemiological, ethical, regulatory and data management terminology

Thoroughly revised and expanded - increase of 280 terms from First Edition, reference to Cochrane included

From the reviews of the First Edition:

"This invaluable text explains the majority of clinical trial terms, in alphabetical order, that are likely to be found in clinical trial protocols, reports, regulatory guidelines, and published manuscripts... Fully comprehensive - provides definitions of clinical trial terms in one complete volume... Includes extensive use of graphs throughout." LA DOC STI

"...covers a range of subject matter, with emphasis on medical, statistical, epidemiological and ethical terms... a useful adjunct to standard clinical trial texts... a reference source to keep within easy reach." TALANTA

The Dictionary of Clinical Trials, Second Edition is a ‘must-have’ for all pharmaceutical companies who conduct a lot of clinical trials, in all or one therapeutic area. The book is also of interest for public health and health science workers, and for contract research organisations and departments of medicine, where medics are involved with clinical trials.

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Paediatric Drug Handling (ULLA Postgraduate Pharmacy Series)

This volume in the "ULLA Series" is an introductory textbook on paediatric drug handling. Written for new pharmaceutical scientists, this book aims to give a background of paediatric pharmacy. Its scope is to give a comprehensive introduction to children's medication in terms of dosing in practice and paediatric pharmaceutics, physiological and drug disposition differences, clinical pharmacology and pharmacogenomics. Paediatric regulations around the world as well as drug licensing and clinical trials, compliance, safety and pharmacovigilance issues will also be developed.

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Introduction to Statistics in Pharmaceutical Clinical Trials

This book is a self-contained introduction to Statistics, presented in the context of clinical trials and pharmaceutical drug development. It focuses on the statistical analyses most commonly used in drug development and is therefore an ideal introduction to pharmaceutical statistics. Instead of introducing a series of statistical techniques, the book's organizational structure follows the order in which numerical information and statistical analyses are used in trials and new drug development.All students taking classes in pharmaceutical sciences and clinical research need a solid knowledge and understanding of the nature, methods, application and importance of Statistics. They need to understand:why, and how data are collected in clinical trials; how these data are summarized and analyzed; what the results mean in the context of the clinical research question; and, how the results are communicated to regulatory agencies and to scientific and medical communities.This title therefore adopts a unique approach and concept in organization of the content. It begins with an introduction to statistical theory, analysis and interpretation. This is followed by a discussion of t-tests and confidence intervals. Readers are then taken through the whole process of new drug development (using one specific example throughout) that is meaningful in the context of their broader studies. Throughout this process, statistical techniques and analyses are introduced in the order in which they are employed during the process.The book's realistic scientific and progressive organization from pre-clinical trials to clinical pharmacology through clinical trials is novel, meaningful and educationally powerful. The book emphasises the importance of descriptive statistics as well as inferential statistics, something that is rarely done.Supplementary material is included for this text on the PharmPress website in the form of PowerPoint lecture notes on Statistics (based on content of this book) that can be downloaded by lecturers.

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Drug Safety Assessment in Clinical Trials

Details the methods pharmaceutical companies employ to determine the safety profile of their drugs as well as surveys statistical procedures currently being used or developed to analyze, display, and compare laboratory data collected from controlled clinical trials.

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Statistical Issues in Drug Development

Statistics in Practice A new series of practical books outlining the use of statistical techniques in a wide range of application areas:
* Human and Biological Sciences
* Earth and Environmental Sciences
* Industry, Commerce and Finance
Statistical Issues in Drug Development Stephen Senn Professor of Pharmaceutical & Health Statistics, University College, London Statistical Issues in Drug Development provides an accessible text for those working directly in drug development, regulatory and marketing departments within the pharmaceutical industry. As a consequence of regulatory authorities demanding increasingly higher standards, statistics has become a critical element in the design and conduct of drug development programmes. The concepts covered in this volume guide the non-statistician through the most pressing statistical issues and controversies in drug development. Key issues covered include:
* Design & interpretation of clinical trials
* Bayesian & frequentist methods
* Sequential & cross-over trials
* Drug monitoring & pharmaco-economics
The book has been prepared in two sections. The first section considers the role of statistics in drug development from four different perspectives: historical, philosophical, technical and professional. The second section covers a series of controversial topics such as fixed versus random effects for meta-analysis, one-sided versus two-sided tests and the ethics of placebo run-ins. The approachable and wide-ranging coverage of this book will make it invaluable to all those working in drug development and regulation.

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Fundamentals of Clinical Research - Statistics for Biology and Health

In recent years many introductory textbooks on clinical trial methodology have been published, some of which are excellent, in addition to a very extensive specialist literature. Nevertheless, here is a new book on methods and issues in clinical research. The objectives can be summarized in three points.

1. Integrate medical and statistical components of clinical research. 

2. Do justice to the operational and practical requirements of clinical research. 

3. Give space to the ethical implications of methodological issues in clinical research.

The scope of clinical research is to evaluate the effect of a treatment on the evolution of a disease in the human species. The treatment can be pharmacological, surgical, psychological/behavioral or organizational/logistic. The disease, intended as an impairment of a state of well-being or a condition capable of provoking such impairment over time, can be universally accepted as such (e.g. a cancer or a bone fracture) or perceived as such only by limited groups of individuals in a given cultural context (e.g. hair loss or weight gain). The course of the disease that ones wishes to change can be the one with no intervention or, more frequently, the one observed with the available treatment. The evaluation of the effect of a treatment on the course of a disease is a lengthy process, which progresses in increasingly complex stages.

A detailed coverage of the logistic, administrative and legal aspects of clinical research is outside the scope of this book. However, throughout the book we keep reminding the reader of these aspects because, as already mentioned, we firmly believe they have a crucial role in determining the success of a study. The history of clinical research is paved with relics of studies started with great pomp, riding great ideas and great hopes, which drowned miserably because of inadequate logistical preparation. In our experience, the excessive complexity of a clinical trial is the single most frequent cause of failure: the study is perfect on paper, but impossible to implement by patients and staff alike. The distance between the principal investigators and the reality of clinical research in its day-to-day practice is often the main cause of such disasters. We warmly encourage everyone involved in clinical research to get involved in the logistics of a study, learning from colleagues responsible for its practical conduct (clinical research associates, data managers, etc.) and to take part, in person, in the practical implementation of a trial before attempting to design a study protocol.

The book ends with a brief description of the drug development process and to the phases of clinical development.

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Drug Products for Clinical Trials: An Intl Guide to Formulation, Production, Quality Control

This practical guide shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace;offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies. The only wide-ranging, up-to-date book of its kind available on the subject! Describing both the science and management of product development, Drug Products for Clinical Trials furnishes effective approaches for preclinical drug discovery addresses the function of the clinical trials materials manager covers the design of clinical protocols in developing a new chemical entity (NCE) explains the importance of bioequivalence between clinical trials materials and final products demonstrates rapid, reliable processes for clinical evaluation discusses the interaction between clinical research, manufacturing, and packaging reviews quality control strategies used in the manufacture of drug substances for clinical studies conducted throughout the world and much more!

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Pharmacoeconomics in Psychiatry

Pharmacoeconomics is a new word but decisions about which treatments are available within any health care system have always been influenced by the availability of resources. Today, the economics of care and treatment are major issues for governments and health services throughout the world. This is the first text to provide an authoritative economic evaluation of the use of drugs in psychiatry. The authors have reviewed the world literature on the subject and include all the most recent data. The book provides pragmatic but scientifically robust reviews of the pharmacoeconomic aspects of drug prescribing in order to improve clinical practice. With the ultimate aim of ensuring that resources are used to the best effect and thus improve the health and quality of life of people with mental health problems, this practical handbook is an important text for psychiatrists and GPs, as well as for health service providers and managers.

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Statistics Applied to Clinical Trials

The previous two editions of this book, rather than being comprehensive, concentrated on the most relevant aspects of statistical analysis. Although well-received by students, clinicians, and researchers, these editions did not answer all their questions. This updated and extended edition serves as a more complete guide and reference text to students, physicians, and investigators, and, at the same time, preserves the common sense approach to statistical problem-solving of the previous editions.

In 1948 the first randomized controlled trial was published by the English Medical Research Council in the British Medical Journal. Until then, observations had been uncontrolled. Initially, trials frequently did not confirm hypotheses to be tested. This phenomenon was attributed to little sensitivity due to small samples, as well as inappropriate hypotheses based on biased prior trials. Additional flaws were being recognized and, subsequently were better accounted for: carryover effects due to insufficient washout from previous treatments, time effects due to external factors and the natural history of the condition under study, bias due to asymmetry between treatment groups, lack of sensitivity due to a negative correlation between treatment responses etc. Such flaws mainly of a technical nature have been largely implemented and lead to trials after 1970 being of significantly better quality than before. The past decade focused, in addition to technical aspects, on the need for circumspection in planning and conducting of clinical trials. As a consequence, prior to approval, clinical trial protocols are now routinely scrutinized by different circumstantial organs, including ethic committees, institutional and federal review boards, national and international scientific organizations, and monitoring committees charged with conducting interim analyses. The present book not only explains classical statistical analyses of clinical trials, but also addresses relatively novel issues, including equivalence testing, interim analyses, sequential analyses, meta-analyses, and provides a framework of the best statistical methods currently available for such purpose. This book is not only useful for investigators involved in the field of clinical trials, but also for students and physicians who wish to better understand the data of trials as published currently.

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Data Monitoring in Clinical Trials: A Case Studies Approach

Randomized clinical trials are the gold standard for establishing many clinical practice guidelines and are central to evidence based medicine. Obtaining the best evidence through clinical trials must be done within the boundaries of rigorous science and ethical principles. One fundamental principle is that trials should not continue longer than necessary to reach their objectives. Therefore, trials must be monitored for recruitment progress, quality of data, adherence to patient care or prevention standards, and early evidence of benefit or harm. Frequently, a group of external experts, independent from the investigators and trial sponsor, is charged with this monitoring responsibility, especially for safety and early benefit. This group is referred to by various names, such as a data monitoring committee or a data and safety monitoring board. This book, through a series of case studies presented by many distinguished clinical trial experts, illustrates the complexity of this monitoring process. The editors provide an overview of the process and a summary of a multitude of the lessons learned from the cases presented.

This book should be useful to anyone serving on a data and safety monitoring board, or planning to do so, for colleagues in academia, industry and governmental agencies, and for teaching students in biostatistics, epidemiology, clinical trials and medical ethics. No other text has as extensive a collection of cases which provide insight into the many issues, often conflicting, that must be examined before recommendations to continue or discontinue a trial can be made. While depth in statistical methods is not required, some familiarity with statistical design and analysis issues in clinical trials is helpful. The cases cover trials which were terminated early for convincing evidence of benefit, or for harmful effects. Cases with complex issues are also included. This series of cases should provide broad background information for potential monitoring committee members and better prepare them for the challenges that may exist in the trials for which they are responsible.

The three editors have contributed two overview chapters as well as several case studies to go along with cases contributed by a distinguished group of colleagues experienced in the design, monitoring and analysis of clinical trials. Dr. David DeMets is currently Professor and Chair, Department of Biostatistics and Medical Informatics at the University of Wisconsin-Madison. He is past president of the Eastern North American Region (ENAR) of the International Biometric Society, a past member of the Board of Directors of the American Statistical Association and an elected Fellow. He recently received the Robert Gordon Lectureship Award, given by the National Institutes of Health, for significant contributions to the field of clinical trials. Dr. Curt Furberg, is currently Professor (and former Chair) of the Department of Public Health Sciences at Wake Forest University. Previously, he was Head of the Clinical Trials Branch and Associate Director of the Clinical Applications and Prevention Program at the National Heart, Lung, and Blood Institute. Dr. Lawrence Friedman is a former Director of the Division of Epidemiology and Clinical Applications and a former Assistant Director for Ethics and Clinical Research at the National Heart, Lung, and Blood Institute. All three are past presidents of the Society of Clinical Trials. The editors have collaborated previously as coauthors of a text: the Fundamentals of Clinical Trials.

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

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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Pharmacotherapy: A Pathophysiologic Approach

The benchmark evidence-based pharmacotherapy text-now in full color!

Additional chapters are available online

When it comes to helping you develop a mastery of evidence-based medicine for optimal patient outcomes, no book can match Pharmacotherapy: A Pathophysiologic Approach. Like the discipline it covers, the scope of this trusted resource goes beyond drug indications and dosages to include the initial selection, proper administration, and monitoring of drugs.

The book also delves into psychosocial issues that affect compliance … topics related to a patient's ability to understand and manage often-complex therapy… and lifestyle changes that may reduce the need for drug therapy or improve pharmacotherapeutic outcomes. Pharmacotherapy delivers everything you need to provide safe, efficacious drug therapy across the full range of therapeutic categories.

FEATURES

• NEW! Expanded evidence-based recommendations
• NEW! Extended coverage of the timely issue of palliative care and pain medicine
• NEW! Important chapters on Pulmonary Hypertension, Disorders of Calcium and Phosphorus Homeostasis, and Multiple Myeloma,
• Outstanding pedagogy, including:
• “Key Concepts” highlighted in each chapter
• “Clinical Presentation” boxes summarize the most common disease signs and symptoms covered in each chapter
• “Clinical Controversies” boxes-presented in the Treatment sections of the disease-oriented chapters-examine the complicated issues faced by students and clinicians in providing drug therapy
• Clear therapeutic recommendations in each disease-specific chapter
• “Evaluation of Therapeutic Outcomes” boxes in each disease-specific chapter, containing key monitoring guidelines that facilitate the development of a pharmaceutical, nursing, or medical care plan

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Drug Delivery to the Lung

This book focuses on the aerosol treatment of lung diseases, recent improvements in the understanding of proper dosage, and major innovations in device technology applied to clinical practice. Examines the behavior of inspired spherical particles in the respiratory tract! Featuring over 1300 references, drawings, tables, photographs, and micrographs, Drug Delivery to the Lung · outlines the history of inhaled medications in the treatment of respiratory disease · describes aspects of respiratory structure to inhalation therapy emphasizing developmental changes · compares existing in vitro/in vivo correlations for key aerosol modalities with lung model predictions · discusses particle diameter measurement, particle size statistics, and aerosol test methods · reviews the clinical effects of altering the deposition site of various classes of aerosolized drugs · surveys the development of novel, efficient, and convenient nebulizer systems · details breath-actuated and spacer devices constructed for children · analyzes dry-powder and pressurized metered dose inhalers · considers the transition from CFCs to new environmentally friendly chemical propellants · and more! Giving the clinician an overview of factors essential to understanding drug delivery via nebulization, Drug Delivery to the Lung is a superlative reference for pulmonologists; physiologists; pharmaceutical scientists; immunologists; allergists; analytical, organic, and medicinal chemists and biochemists; chemical, genetic, and process engineers; and medical and graduate school students in these disciplines.

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Liposomes : Rasional Design

This up-to-date reference covers the basics of liposomology, offering insights from over 30 scientists involved in its growth and considering the direction of future developments. Describes the liposome patent portfolio developed over the last 30 years! Outlining the procedures that bring liposome pharmaceuticals from laboratory to clinic, Liposomes · discusses the design of clinical trials · analyzes morphological diversity and functionality in gene delivery · highlights antitumor activities of lipids acting as second messengers · suggests how antibodies to cholesterol can be used therapeutically · explores applications of liposomes with high captured volumes · details the clinical detection of antilipid antibodies · addresses the lyophilization of liposomes · and more! With over 1400 references, tables, drawings, and photographs, Liposomes is suitable for industrial, clinical, and research pharmacists; pharmacologists; research and development scientists in the pharmaceutical, food, cosmetic, veterinary, agricultural, and chemical industries; biochemists; industrial, medicinal, organic, and pharmaceutical chemists; biophysicists; biotechnologists; microbiologists; molecular and cell biologists; and graduate students in these disciplines.

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Principles and Practice of Clinical Trial Medicine

Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, this book covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results.

*Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data.
*Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine.
*Expert authorship whose experience includes running clinical trials in an academic as well as industry settings.
*Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy.

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Pharmaceutical Care Practice: The Clinician's Guide

The most practical approach to pharmaceutical care! Provides all the principles and practice components for the pharmaceutical care practice course in the pharmacy curriculum. Thoroughly revised and updated, this edition includes expanded coverage of reimbursement, documentation, and data models associated with the practice.

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Pharmacotherapy Handbook

The second edition of the Pharmacotherapy Handbook provides readers with a portable, readable guide that is integral to any clinical setting. Bold-face type highlights drug names when they first appear and in all closing information. The book's bulleted format helps readers find the information they need immediately. This updated book was designed as a companion text for the fourth edition Pharmacotherapy: A Pathophysiologic Approach.

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A Practical Guide to Quality Management in Clinical Trial Research

Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a cornerstone of knowledge for establishing a quality system that complies with the relevant regulations. There are many books available that cover how to interpret regulations. Going a step or two further, this book provides practical advice that is useful on a daily basis. The book contains information for various standards including GLPs, GCPs, and GMPs. It gives detailed explanations of how to prepare, update, and maintain SOPs and includes advice on training and development of personnel. Drawing directly on his years of experience, the author delineates a from-the-trenches methodology that creates a value-added quality management system from a business perspective. He provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations. The author's integrated approach and anecdotal style turns technically accurate information into easy reading. The book arms you with tools and concepts that you can use to go beyond regulatory compliance and move into the realm of business quality improvement.

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