A Practical Guide To Designing Phase Ii Trials In Oncology

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A Practical Guide to Designing Phase II Trials in Oncology

Author : Sarah R. Brown
Publisher : John Wiley & Sons
ISBN 13 : 1118763637
Total Pages : 260 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis A Practical Guide to Designing Phase II Trials in Oncology by : Sarah R. Brown

Download or read book A Practical Guide to Designing Phase II Trials in Oncology written by Sarah R. Brown and published by John Wiley & Sons. This book was released on 2014-03-28 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

A Practical Guide to Designing Phase II Trials in Oncology

Author : Sarah R. Brown
Publisher : John Wiley & Sons
ISBN 13 : 1118570901
Total Pages : 260 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis A Practical Guide to Designing Phase II Trials in Oncology by : Sarah R. Brown

Download or read book A Practical Guide to Designing Phase II Trials in Oncology written by Sarah R. Brown and published by John Wiley & Sons. This book was released on 2014-05-12 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Phase I Cancer Clinical Trials

Author : Elizabeth A. Eisenhauer
Publisher : Oxford University Press, USA
ISBN 13 : 0199359016
Total Pages : 369 pages
Book Rating : 4.1/5 (993 download)

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Book Synopsis Phase I Cancer Clinical Trials by : Elizabeth A. Eisenhauer

Download or read book Phase I Cancer Clinical Trials written by Elizabeth A. Eisenhauer and published by Oxford University Press, USA. This book was released on 2014-06 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. As this title is the only comprehensive book on this topic, it 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.

Phase I Cancer Clinical Trials

Author : Elizabeth A. Eisenhauer
Publisher :
ISBN 13 :
Total Pages : 372 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Phase I Cancer Clinical Trials by : Elizabeth A. Eisenhauer

Download or read book Phase I Cancer Clinical Trials written by Elizabeth A. Eisenhauer and published by . This book was released on 2006 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: Phase I trials are the first step in the study of novel therapeutic approaches. They aim to identify the recommended dose, schedule and pharmacologic behavior of new drugs, and to describe the adverse effects of treatment. This practical guide discusses the design, conduct, analysis and ethical aspects of Phase I cancer trials.

Phase I Cancer Clinical Trials

Author : Elizabeth A. Eisenhauer
Publisher : Oxford University Press
ISBN 13 : 0199359024
Total Pages : 369 pages
Book Rating : 4.1/5 (993 download)

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Book Synopsis Phase I Cancer Clinical Trials by : Elizabeth A. Eisenhauer

Download or read book Phase I Cancer Clinical Trials written by Elizabeth A. Eisenhauer and published by Oxford University Press. This book was released on 2015-03-20 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Dose-Finding Designs for Early-Phase Cancer Clinical Trials

Author : Takashi Daimon
Publisher : Springer
ISBN 13 : 4431555854
Total Pages : 133 pages
Book Rating : 4.4/5 (315 download)

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Book Synopsis Dose-Finding Designs for Early-Phase Cancer Clinical Trials by : Takashi Daimon

Download or read book Dose-Finding Designs for Early-Phase Cancer Clinical Trials written by Takashi Daimon and published by Springer. This book was released on 2019-05-21 with total page 133 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive introduction to statistical methods for designing early phase dose-finding clinical trials. It will serve as a textbook or handbook for graduate students and practitioners in biostatistics and clinical investigators who are involved in designing, conducting, monitoring, and analyzing dose-finding trials. The book will also provide an overview of advanced topics and discussions in this field for the benefit of researchers in biostatistics and statistical science. Beginning with backgrounds and fundamental notions on dose finding in early phase clinical trials, the book then provides traditional and recent dose-finding designs of phase I trials for, e.g., cytotoxic agents in oncology, to evaluate toxicity outcome. Included are rule-based and model-based designs, such as 3 + 3 designs, accelerated titration designs, toxicity probability interval designs, continual reassessment method and related designs, and escalation overdose control designs. This book also covers more complex and updated dose-finding designs of phase I-II and I/II trials for cytotoxic agents, and cytostatic agents, focusing on both toxicity and efficacy outcomes, such as designs with covariates and drug combinations, maximum tolerated dose-schedule finding designs, and so on.

Oncology Clinical Trials

Author : Susan Halabi, PhD
Publisher : Demos Medical Publishing
ISBN 13 : 1935281763
Total Pages : 396 pages
Book Rating : 4.9/5 (352 download)

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Book Synopsis Oncology Clinical Trials by : Susan Halabi, PhD

Download or read book Oncology Clinical Trials written by Susan Halabi, PhD and published by Demos Medical Publishing. This book was released on 2009-12-22 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout

Clinical Trials

Author : Ameet Bakhai
Publisher :
ISBN 13 : 9781905721290
Total Pages : 480 pages
Book Rating : 4.7/5 (212 download)

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Book Synopsis Clinical Trials by : Ameet Bakhai

Download or read book Clinical Trials written by Ameet Bakhai and published by . This book was released on 2006 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. --

Randomized Phase II Cancer Clinical Trials

Author : Sin-Ho Jung
Publisher : CRC Press
ISBN 13 : 143987185X
Total Pages : 250 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Randomized Phase II Cancer Clinical Trials by : Sin-Ho Jung

Download or read book Randomized Phase II Cancer Clinical Trials written by Sin-Ho Jung and published by CRC Press. This book was released on 2013-05-02 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: In cancer research, a traditional phase II trial is designed as a single-arm trial that compares the experimental therapy to a historical control. This simple trial design has led to several adverse issues, including increased false positivity of phase II trial results and negative phase III trials. To rectify these problems, oncologists and biostatisticians have begun to use a randomized phase II trial that compares an experimental therapy with a prospective control therapy. Randomized Phase II Cancer Clinical Trials explains how to properly select and accurately use diverse statistical methods for designing and analyzing phase II trials. The author first reviews the statistical methods for single-arm phase II trials since some methodologies for randomized phase II trials stem from single-arm phase II trials and many phase II cancer clinical trials still use single-arm designs. The book then presents methods for randomized phase II trials and describes statistical methods for both single-arm and randomized phase II trials. Although the text focuses on phase II cancer clinical trials, the statistical methods covered can also be used (with minor modifications) in phase II trials for other diseases and in phase III cancer clinical trials. Suitable for cancer clinicians and biostatisticians, this book shows how randomized phase II trials with a prospective control resolve the shortcomings of traditional single-arm phase II trials. It provides readers with numerous statistical design and analysis methods for randomized phase II trials in oncology.

Clinical Trials in Oncology, Third Edition

Author : Stephanie Green
Publisher : CRC Press
ISBN 13 : 1439814481
Total Pages : 266 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Clinical Trials in Oncology, Third Edition by : Stephanie Green

Download or read book Clinical Trials in Oncology, Third Edition written by Stephanie Green and published by CRC Press. This book was released on 2012-05-09 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.

Oncology Clinical Trials

Author : Susan Halabi, PhD
Publisher : Demos Medical Publishing
ISBN 13 : 1935281763
Total Pages : 397 pages
Book Rating : 4.9/5 (352 download)

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Book Synopsis Oncology Clinical Trials by : Susan Halabi, PhD

Download or read book Oncology Clinical Trials written by Susan Halabi, PhD and published by Demos Medical Publishing. This book was released on 2009-12-22 with total page 397 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout

Fast Facts: Clinical Trials in Oncology

Author : Allan Hackshaw
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 1912776731
Total Pages : 120 pages
Book Rating : 4.9/5 (127 download)

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Book Synopsis Fast Facts: Clinical Trials in Oncology by : Allan Hackshaw

Download or read book Fast Facts: Clinical Trials in Oncology written by Allan Hackshaw and published by Karger Medical and Scientific Publishers. This book was released on 2020-12-18 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by leading experts, 'Fast Facts: Clinical Trials in Oncology' will enhance the reader’s ability to critically evaluate published evidence. Assuming little or no prior knowledge, the book sets out clearly the fundamental features of clinical trials. The key attributes of Phase I–III trials of pharmaceutical products are described, as are trials of surgical procedures, radiation therapy and advanced therapies. The processes and documentation required to set up and conduct a trial are outlined, and the authors describe how trial data and real-world evidence are used to improve care. Although this concise colorful book focuses on oncology, the principles apply equally to interventions in other areas of practice. It will prove invaluable to medical, pharmaceutical and allied health professionals who want, or need, an overview of how contemporary clinical trials are designed and conducted. Contents: • Fundamental features of clinical trials • Phase I trials • Phase II trials • Phase III trials • Trials of non-drug interventions • Setting up and conducting trials • Publishing trial results, changing clinical practice, and supporting evidence

Textbook of Clinical Trials in Oncology

Author : Susan Halabi
Publisher : CRC Press
ISBN 13 : 1351620967
Total Pages : 701 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Textbook of Clinical Trials in Oncology by : Susan Halabi

Download or read book Textbook of Clinical Trials in Oncology written by Susan Halabi and published by CRC Press. This book was released on 2019-04-24 with total page 701 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology. Key Features: Cutting-edge topics with appropriate technical background Built around case studies which give the work a "hands-on" approach Real examples of flaws in previously reported clinical trials and how to avoid them Access to statistical code on the book’s website Chapters written by internationally recognized statisticians from academia and pharmaceutical companies Carefully edited to ensure consistency in style, level, and approach Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others

Clinical Trials

Author : Tom Brody
Publisher : Academic Press
ISBN 13 : 0128042583
Total Pages : 897 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Clinical Trials by : Tom Brody

Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2016-02-19 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers

Bayesian Designs for Phase I-II Clinical Trials

Author : Ying Yuan
Publisher : CRC Press
ISBN 13 : 1498709567
Total Pages : 310 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Bayesian Designs for Phase I-II Clinical Trials by : Ying Yuan

Download or read book Bayesian Designs for Phase I-II Clinical Trials written by Ying Yuan and published by CRC Press. This book was released on 2017-12-19 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.

Cancer Clinical Trials

Author : Stephen L. George
Publisher : CRC Press
ISBN 13 : 1315354330
Total Pages : 374 pages
Book Rating : 4.3/5 (153 download)

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Book Synopsis Cancer Clinical Trials by : Stephen L. George

Download or read book Cancer Clinical Trials written by Stephen L. George and published by CRC Press. This book was released on 2016-08-19 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.

The Design of Studies for Medical Research

Author : David Machin
Publisher : John Wiley & Sons
ISBN 13 : 0470012986
Total Pages : 286 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis The Design of Studies for Medical Research by : David Machin

Download or read book The Design of Studies for Medical Research written by David Machin and published by John Wiley & Sons. This book was released on 2005-05-13 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: The same careful rigour imposed on the design of phase III randomised controlled trials is not always applied to medical research in other areas such as trials conducted at earlier stages of drug development. With the emphasis that is now placed on evidence-based medicine, such care and rigour will inevitably impact on these areas with increasing attention turned to the quality of design. This title describes what principles can be used to structure research effectively allowing for the required degree of accuracy. Written by two best selling authors, this book includes many examples from medical literature and will be of great value to all groups conducting studies at the interface of clinical and laboratory research.