Designs For Clinical Trials

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Small Clinical Trials

Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Small Clinical Trials Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Publisher : National Academies Press
Page : 222 pages
File Size : 53,6 Mb
Release : 2001-01-01
Category : Medical
ISBN : 0309171148

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Small Clinical Trials by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials Pdf

Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Designing Clinical Research

Stephen B. Hulley,Steven R. Cummings,Warren S. Browner,Deborah G. Grady,Thomas B. Newman
Designing Clinical Research Book PDF

Author : Stephen B. Hulley,Steven R. Cummings,Warren S. Browner,Deborah G. Grady,Thomas B. Newman
Publisher : Lippincott Williams & Wilkins
Page : 388 pages
File Size : 45,8 Mb
Release : 2011-11-30
Category : Medical
ISBN : 9781451165852

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Designing Clinical Research by Stephen B. Hulley,Steven R. Cummings,Warren S. Browner,Deborah G. Grady,Thomas B. Newman Pdf

Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.

Randomised Response-Adaptive Designs in Clinical Trials

Anthony C Atkinson,Atanu Biswas
Randomised Response Adaptive Designs in Clinical Trials Book PDF

Author : Anthony C Atkinson,Atanu Biswas
Publisher : CRC Press
Page : 341 pages
File Size : 50,8 Mb
Release : 2013-12-26
Category : Mathematics
ISBN : 9781584886938

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Randomised Response-Adaptive Designs in Clinical Trials by Anthony C Atkinson,Atanu Biswas Pdf

Randomised Response-Adaptive Designs in Clinical Trials presents methods for the randomised allocation of treatments to patients in sequential clinical trials. Emphasizing the practical application of clinical trial designs, the book is designed for medical and applied statisticians, clinicians, and statisticians in training. After introducing clinical trials in drug development, the authors assess a simple adaptive design for binary responses without covariates. They discuss randomisation and covariate balance in normally distributed responses and cover many important response-adaptive designs for binary responses. The book then develops response-adaptive designs for continuous and longitudinal responses, optimum designs with covariates, and response-adaptive designs with covariates. It also covers response-adaptive designs that are derived by optimising an objective function subject to constraints on the variance of estimated parametric functions. The concluding chapter explores future directions in the development of adaptive designs.

Group Sequential and Confirmatory Adaptive Designs in Clinical Trials

Gernot Wassmer,Werner Brannath
Group Sequential and Confirmatory Adaptive Designs in Clinical Trials Book PDF

Author : Gernot Wassmer,Werner Brannath
Publisher : Springer
Page : 301 pages
File Size : 45,7 Mb
Release : 2016-07-04
Category : Medical
ISBN : 9783319325620

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Group Sequential and Confirmatory Adaptive Designs in Clinical Trials by Gernot Wassmer,Werner Brannath Pdf

This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop the trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-arm selection or a selection of a pre-specified sub-population. Essentially, this adaptive methodology was introduced in the 1990s. Since then, it has become popular and the object of intense discussion and still represents a rapidly growing field of statistical research. This book describes adaptive design methodology at an elementary level, while also considering designing and planning issues as well as methods for analyzing an adaptively planned trial. This includes estimation methods and methods for the determination of an overall p-value. Part I of the book provides the group sequential methods that are necessary for understanding and applying the adaptive design methodology supplied in Parts II and III of the book. The book contains many examples that illustrate use of the methods for practical application. The book is primarily written for applied statisticians from academia and industry who are interested in confirmatory adaptive designs. It is assumed that readers are familiar with the basic principles of descriptive statistics, parameter estimation and statistical testing. This book will also be suitable for an advanced statistical course for applied statisticians or clinicians with a sound statistical background.

Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio

Mark Chang
Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio Book PDF

Author : Mark Chang
Publisher : John Wiley & Sons
Page : 284 pages
File Size : 55,5 Mb
Release : 2010-06-15
Category : Medical
ISBN : 9780470438565

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Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio by Mark Chang Pdf

ExpDesign Studio facilitates more efficient clinical trial design This book introduces pharmaceutical statisticians, scientists, researchers, and others to ExpDesign Studio software for classical and adaptive designs of clinical trials. It includes the Professional Version 5.0 of ExpDesign Studio software that frees pharmaceutical professionals to focus on drug development and related challenges while the software handles the essential calculations and computations. After a hands-on introduction to the software and an overview of clinical trial designs encompassing numerous variations, Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio: Covers both classical and adaptive clinical trial designs, monitoring, and analyses Explains various classical and adaptive designs including groupsequential, sample-size reestimation, dropping-loser, biomarker-adaptive, and response-adaptive randomization designs Includes instructions for over 100 design methods that have been implemented in ExpDesign Studio and step-by-step demos as well as real-world examples Emphasizes applications, yet covers key mathematical formulations Introduces readers to additional toolkits in ExpDesign Studio that help in designing, monitoring, and analyzing trials, such as the adaptive monitor, graphical calculator, the probability calculator, the confidence interval calculator, and more Presents comprehensive technique notes for sample-size calculation methods, grouped by the number of arms, the trial endpoint, and the analysis basis Written with practitioners in mind, this is an ideal self-study guide for not only statisticians, but also scientists, researchers, and professionals in the pharmaceutical industry, contract research organizations (CROs), and regulatory bodies. It's also a go-to reference for biostatisticians, pharmacokinetic specialists, and principal investigators involved in clinical trials. ERRATUM Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio By Mark Chang The license for the ExpDesign Studio software on the CD included with this book is good for one-year after installation of the software. Prior to the expiration of this period, the software will generate a reminder about renewal for the license. The user should contact CTriSoft International (the owners of ExpDesign Studio) at www.CTriSoft.net or by email at [email protected], about renewal for the license. This should have been made clear in the first printing of this book. We apologize for this error.

Designs for Clinical Trials

David Harrington
Designs for Clinical Trials Book PDF

Author : David Harrington
Publisher : Springer Science & Business Media
Page : 206 pages
File Size : 51,9 Mb
Release : 2011-10-09
Category : Medical
ISBN : 1461401402

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Designs for Clinical Trials by David Harrington Pdf

This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials.

Design and Analysis of Clinical Trials

Shein-Chung Chow,Jen-Pei Liu
Design and Analysis of Clinical Trials Book PDF

Author : Shein-Chung Chow,Jen-Pei Liu
Publisher : Wiley-Interscience
Page : 680 pages
File Size : 41,9 Mb
Release : 1998-06-23
Category : Mathematics
ISBN : UOM:39015047055416

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Design and Analysis of Clinical Trials by Shein-Chung Chow,Jen-Pei Liu Pdf

A unique, unifying treatment for statistics and science in clinical trials What sets this volume apart from the many books dealing with clinical trials is its integration of statistical and clinical disciplines. Stressing communication between biostatisticians and clinical scientists, this work clearly relates statistical interpretation to clinical issues arising in different stages of pharmaceutical research and development. Plus, the principles presented here are universal enough to be easily adapted in non-biopharmaceutical settings. Design and Analysis of Clinical Trials tackles concepts and methodologies. It not only covers statistical basics such as uncertainty and bias, design considerations such as patient selection, randomization, and the different types of clinical trials but also deals with various methods of data analysis, group sequential procedures for interim analysis, efficacy data evaluation, analysis of safety data, and more. Throughout, the book: * Surveys current and emerging clinical issues and newly developed statistical methods * Presents a critical review of statistical methodologies in various therapeutic areas * Features case studies from actual clinical trials * Minimizes the mathematics involved, making the material widely accessible * Offers each chapter as a self-contained entity * Includes illustrations to highlight the text This monumental reference on all facets of clinical trials is important reading for physicians, clinical and medical researchers, pharmaceutical scientists, clinical programmers, biostatisticians, and anyone involved in this burgeoning area of clinical research. It can also be used as a textbook in graduate-level courses in the field.

Adaptive Design Methods in Clinical Trials

Shein-Chung Chow,Mark Chang
Adaptive Design Methods in Clinical Trials Book PDF

Author : Shein-Chung Chow,Mark Chang
Publisher : CRC Press
Page : 368 pages
File Size : 43,6 Mb
Release : 2011-12-01
Category : Mathematics
ISBN : 9781439839881

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Adaptive Design Methods in Clinical Trials by Shein-Chung Chow,Mark Chang Pdf

With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clini

Bayesian Adaptive Methods for Clinical Trials

Scott M. Berry,Bradley P. Carlin,J. Jack Lee,Peter Muller
Bayesian Adaptive Methods for Clinical Trials Book PDF

Author : Scott M. Berry,Bradley P. Carlin,J. Jack Lee,Peter Muller
Publisher : CRC Press
Page : 316 pages
File Size : 54,9 Mb
Release : 2010-07-19
Category : Mathematics
ISBN : 9781439825518

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Bayesian Adaptive Methods for Clinical Trials by Scott M. Berry,Bradley P. Carlin,J. Jack Lee,Peter Muller Pdf

Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adapti

Sequential Experimentation in Clinical Trials

Jay Bartroff,Tze Leung Lai,Mei-Chiung Shih
Sequential Experimentation in Clinical Trials Book PDF

Author : Jay Bartroff,Tze Leung Lai,Mei-Chiung Shih
Publisher : Springer Science & Business Media
Page : 250 pages
File Size : 40,5 Mb
Release : 2012-12-12
Category : Medical
ISBN : 9781461461142

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Sequential Experimentation in Clinical Trials by Jay Bartroff,Tze Leung Lai,Mei-Chiung Shih Pdf

Sequential Experimentation in Clinical Trials: Design and Analysis is developed from decades of work in research groups, statistical pedagogy, and workshop participation. Different parts of the book can be used for short courses on clinical trials, translational medical research, and sequential experimentation. The authors have successfully used the book to teach innovative clinical trial designs and statistical methods for Statistics Ph.D. students at Stanford University. There are additional online supplements for the book that include chapter-specific exercises and information. Sequential Experimentation in Clinical Trials: Design and Analysis covers the much broader subject of sequential experimentation that includes group sequential and adaptive designs of Phase II and III clinical trials, which have attracted much attention in the past three decades. In particular, the broad scope of design and analysis problems in sequential experimentation clearly requires a wide range of statistical methods and models from nonlinear regression analysis, experimental design, dynamic programming, survival analysis, resampling, and likelihood and Bayesian inference. The background material in these building blocks is summarized in Chapter 2 and Chapter 3 and certain sections in Chapter 6 and Chapter 7. Besides group sequential tests and adaptive designs, the book also introduces sequential change-point detection methods in Chapter 5 in connection with pharmacovigilance and public health surveillance. Together with dynamic programming and approximate dynamic programming in Chapter 3, the book therefore covers all basic topics for a graduate course in sequential analysis designs.

Phase I Oncology Drug Development

Timothy A. Yap,Jordi Rodon,David S. Hong
Phase I Oncology Drug Development Book PDF

Author : Timothy A. Yap,Jordi Rodon,David S. Hong
Publisher : Springer Nature
Page : 352 pages
File Size : 55,5 Mb
Release : 2020-09-16
Category : Medical
ISBN : 9783030476823

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Phase I Oncology Drug Development by Timothy A. Yap,Jordi Rodon,David S. Hong Pdf

This book provides a detailed review of how oncology drug development has changed over the past decade, and serves as a comprehensive guide for the practicalities in setting up phase I trials. The book covers strategies to accelerate the development of novel antitumor compounds from the laboratory to clinical trials and beyond through the use of innovative mechanism-of-action pharmacodynamic biomarkers and pharmacokinetic studies. The reader will learn about all aspects of modern phase I trial designs, including the incorporation of precision medicine strategies, and approaches for rational patient allocation to novel anticancer therapies. Circulating biomarkers to assess mechanisms of response and resistance are changing the way we are assessing patient selection and are also covered in this book. The development of the different classes of antitumor agents are discussed, including chemotherapy, molecularly targeted agents, immunotherapies and also radiotherapy. The authors also discuss the lessons that the oncology field has learnt from the development of hematology-oncology drugs and how such strategies can be carried over into therapies for solid tumors. There is a dedicated chapter that covers the specialized statistical approaches necessary for phase I trial designs, including novel Bayesian strategies for dose escalation. This volume is designed to help clinicians better understand phase I clinical trials, but would also be of use to translational researchers (MDs and PhDs), and drug developers from academia and industry interested in cancer drug development. It could also be of use to phase I trial study coordinators, oncology nurses and advanced practice providers. Other health professionals interested in the treatment of cancer will also find this book of great value.

The Prevention and Treatment of Missing Data in Clinical Trials

National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
The Prevention and Treatment of Missing Data in Clinical Trials Book PDF

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
Publisher : National Academies Press
Page : 163 pages
File Size : 43,9 Mb
Release : 2010-12-21
Category : Medical
ISBN : 9780309186513

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The Prevention and Treatment of Missing Data in Clinical Trials by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials Pdf

Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Clinical Trials

Tom Brody
Clinical Trials Book PDF

Author : Tom Brody
Publisher : Academic Press
Page : 897 pages
File Size : 42,5 Mb
Release : 2016-02-19
Category : Medical
ISBN : 9780128042588

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Clinical Trials by Tom Brody Pdf

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

Ying Yuan,Hoang Q. Nguyen,Peter F. Thall
Bayesian Designs for Phase I II Clinical Trials Book PDF

Author : Ying Yuan,Hoang Q. Nguyen,Peter F. Thall
Publisher : CRC Press
Page : 233 pages
File Size : 51,6 Mb
Release : 2017-12-19
Category : Mathematics
ISBN : 9781315354224

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Bayesian Designs for Phase I-II Clinical Trials by Ying Yuan,Hoang Q. Nguyen,Peter F. Thall Pdf

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.

Clinical Trial Design

Sue Fitzpatrick
Clinical Trial Design Book PDF

Author : Sue Fitzpatrick
Publisher : Inst of Clinical Research
Page : 60 pages
File Size : 40,5 Mb
Release : 2006
Category : Clinical trials
ISBN : 9781905238033

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Clinical Trial Design by Sue Fitzpatrick Pdf

Gives advice on how to design a clinical trial and compares the different designs.