Strategy And Statistics In Clinical Trials

✏Book Title : Strategy and Statistics in Clinical Trials
✏Author : Joseph Tal
✏Publisher : Academic Press
✏Release Date : 2011
✏Pages : 267
✏ISBN : 9780123869098
✏Available Language : English, Spanish, And French

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✏Strategy and Statistics in Clinical Trials Book Summary : Strategy and Statistics in Clinical Trials is for all individuals engaged in clinical research, including professors, physicians, researchers in corporate and government laboratories, nurses, members of the allied health professions, and post-doctoral and graduate students who are potentially less exposed to understanding the pivotal role of statistics. . Enables nonstatisticians to better understand research processes and statistics' role in these processes . Offers real-life case studies and provides a practical, "how to" guide to biomedical R&D . Delineates the statistical building blocks and concepts of clinical trials . Promotes effective cooperation between statisticians and important other parties.

✏Book Title : Exam Prep for Strategy and Statistics in Clinical Trials
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✏Available Language : English, Spanish, And French

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✏Exam Prep for Strategy and Statistics in Clinical Trials Book Summary :

✏Book Title : Innovative Strategies Statistical Solutions and Simulations for Modern Clinical Trials
✏Author : Mark Chang
✏Publisher : CRC Press
✏Release Date : 2019-03-20
✏Pages : 362
✏ISBN : 9781351214537
✏Available Language : English, Spanish, And French

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✏Innovative Strategies Statistical Solutions and Simulations for Modern Clinical Trials Book Summary : "This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.

✏Book Title : Small Clinical Trials
✏Author : Institute of Medicine
✏Publisher : National Academies Press
✏Release Date : 2001-01-01
✏Pages : 222
✏ISBN : 0309171148
✏Available Language : English, Spanish, And French

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✏Small Clinical Trials Book Summary : 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.

✏Book Title : Clinical Trial Biostatistics and Biopharmaceutical Applications
✏Author : Walter R. Young
✏Publisher : CRC Press
✏Release Date : 2014-11-20
✏Pages : 580
✏ISBN : 9781482212181
✏Available Language : English, Spanish, And French

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✏Clinical Trial Biostatistics and Biopharmaceutical Applications Book Summary : Since 1945, "The Annual Deming Conference on Applied Statistics" has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications from the pharmaceutical industry. Divided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of Phase II dose-ranging trials, thorough QT/QTc clinical trials, and assay sensitivity and the constancy assumption in noninferiority trials. The second section examines adaptive designs in drug development, discusses the consequences of group-sequential and adaptive designs, and illustrates group sequential design in R. The third section focuses on oncology clinical trials, covering competing risks, escalation with overdose control (EWOC) dose finding, and interval-censored time-to-event data. In the fourth section, the book describes multiple test problems with applications to adaptive designs, graphical approaches to multiple testing, the estimation of simultaneous confidence intervals for multiple comparisons, and weighted parametric multiple testing methods. The final section discusses the statistical analysis of biomarkers from omics technologies, biomarker strategies applicable to clinical development, and the statistical evaluation of surrogate endpoints. This book clarifies important issues when designing and analyzing clinical trials, including several misunderstood and unresolved challenges. It will help readers choose the right method for their biostatistical application. Each chapter is self-contained with references.

✏Book Title : Statistical Methods for Clinical Trials
✏Author : Mark X. Norleans
✏Publisher : CRC Press
✏Release Date : 2000-11-08
✏Pages : 276
✏ISBN : 0824704673
✏Available Language : English, Spanish, And French

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✏Statistical Methods for Clinical Trials Book Summary : "Summarizes graphical analysis, analysis of variance, meta-analysis, and design of comparable treatment groups. Streamlines the analytical techniques for continuous, categorical, longitudinal, and survival data-focusing on generalized linear models, GEEs, and mixed linear models, -ahd highlihgts p-value, and more."

✏Book Title : Handbook for Clinical Research
✏Author : Flora Hammond, MD
✏Publisher : Demos Medical Publishing
✏Release Date : 2014-08-26
✏Pages : 290
✏ISBN : 9781936287543
✏Available Language : English, Spanish, And French

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✏Handbook for Clinical Research Book Summary : The majority of physicians are poorly knowledgeable about statistics and research design, yet are expected to do clinical research and write articles (if in academia) or, at the very least, to read the literature critically and provide evidence-based care to patients. The basic skills involved are touched on very minimally in residency, but not in enough depth for an untrained investigator to successfully design or conduct a study, or analyze research findings in any meaningful way. This volume is intended as a “quick fix”, allowing readers to look up information rapidly about various design types and statistical methods to see what the pros, cons, and indications for each are. Research implementation, including regulatory issues and grant writing, is also covered. The book is unique in physical medicine and rehabilitation, and with the increased emphasis on outcomes measurement and push toward a national agenda for disability research, will appeal both to investigators planning and executing studies and clinicians looking to better understand how the findings impact their practice. A list of topics with an outline of headings for each of the sections is attached.

✏Book Title : Methods and Applications of Statistics in Clinical Trials Volume 1
✏Author : N. Balakrishnan
✏Publisher : John Wiley & Sons
✏Release Date : 2014-03-05
✏Pages : 992
✏ISBN : 9781118595916
✏Available Language : English, Spanish, And French

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✏Methods and Applications of Statistics in Clinical Trials Volume 1 Book Summary : A complete guide to the key statistical concepts essential for the design and construction of clinical trials As the newest major resource in the field of medical research, Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs presents a timely and authoritative reviewof the central statistical concepts used to build clinical trials that obtain the best results. The referenceunveils modern approaches vital to understanding, creating, and evaluating data obtained throughoutthe various stages of clinical trial design and analysis. Accessible and comprehensive, the first volume in a two-part set includes newly-written articles as well as established literature from the Wiley Encyclopedia of Clinical Trials. Illustrating a variety of statistical concepts and principles such as longitudinal data, missing data, covariates, biased-coin randomization, repeated measurements, and simple randomization, the book also provides in-depth coverage of the various trial designs found within phase I-IV trials. Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs also features: Detailed chapters on the type of trial designs, such as adaptive, crossover, group-randomized, multicenter, non-inferiority, non-randomized, open-labeled, preference, prevention, and superiority trials Over 100 contributions from leading academics, researchers, and practitioners An exploration of ongoing, cutting-edge clinical trials on early cancer and heart disease, mother-to-child human immunodeficiency virus transmission trials, and the AIDS Clinical Trials Group Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs is an excellent reference for researchers, practitioners, and students in the fields of clinicaltrials, pharmaceutics, biostatistics, medical research design, biology, biomedicine, epidemiology,and public health.

✏Book Title : The Prevention and Treatment of Missing Data in Clinical Trials
✏Author : National Research Council
✏Publisher : National Academies Press
✏Release Date : 2011-01-21
✏Pages : 162
✏ISBN : 9780309158145
✏Available Language : English, Spanish, And French

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✏The Prevention and Treatment of Missing Data in Clinical Trials Book Summary : 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.

✏Book Title : Controversial Statistical Issues in Clinical Trials
✏Author : Shein-Chung Chow
✏Publisher : CRC Press
✏Release Date : 2016-04-19
✏Pages : 611
✏ISBN : 9781439849620
✏Available Language : English, Spanish, And French

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✏Controversial Statistical Issues in Clinical Trials Book Summary : In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials covers commonly encountered controversial statistical issues in clinical trials and, whenever possible, makes recommendations to resolve these problems. The book focuses on issues occurring at various stages of clinical research and development, including early-phase clinical development (such as bioavailability/bioequivalence), bench-to-bedside translational research, and late-phase clinical development. Numerous examples illustrate the impact of these issues on the evaluation of the safety and efficacy of the test treatment under investigation. The author also offers recommendations regarding possible resolutions of the problems. Written by one of the preeminent experts in the field, this book provides a useful desk reference and state-of-the art examination of problematic issues in clinical trials for scientists in the pharmaceutical industry, medical/statistical reviewers in government regulatory agencies, and researchers and students in academia.

✏Book Title : Planning and Analyzing Clinical Trials with Composite Endpoints
✏Author : Geraldine Rauch
✏Publisher : Springer
✏Release Date : 2018-05-22
✏Pages : 255
✏ISBN : 9783319737706
✏Available Language : English, Spanish, And French

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✏Planning and Analyzing Clinical Trials with Composite Endpoints Book Summary : This book addresses the most important aspects of how to plan and evaluate clinical trials with a composite primary endpoint to guarantee a clinically meaningful and valid interpretation of the results. Composite endpoints are often used as primary efficacy variables for clinical trials, particularly in the fields of oncology and cardiology. These endpoints combine several variables of interest within a single composite measure, and as a result, all variables that are of major clinical relevance can be considered in the primary analysis without the need to adjust for multiplicity. Moreover, composite endpoints are intended to increase the size of the expected effects thus making clinical trials more powerful. The book offers practical advice for statisticians and medical experts involved in the planning and analysis of clinical trials. For readers who are mainly interested in the application of the methods, all the approaches are illustrated with real-world clinical trial examples, and the software codes required for fast and easy implementation are provided. The book also discusses all the methods in the context of relevant guidelines related to the topic. To benefit most from the book, readers should be familiar with the principles of clinical trials and basic statistical methods.

✏Book Title : Biostatistics in Clinical Trials
✏Author : Carol K. Redmond
✏Publisher : John Wiley & Sons
✏Release Date : 2001-04-25
✏Pages : 522
✏ISBN : 0471822116
✏Available Language : English, Spanish, And French

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✏Biostatistics in Clinical Trials Book Summary : The second volume in the Wiley reference series in Biostatistics. Featuring articles from the prestigious Encyclopedia of Biostatistics, many of which have been fully revised and updated to include recent developments, Biostatistics in Clinical Trials also includes up to 25% newly commissioned material reflecting the latest thinking in: Bayesian methods Benefit/risk assessment Cost-effectiveness Ethics Fraud With exceptional contributions from leading experts in academia, government and industry, Biostatistics in Clinical Trials has been designed to complement existing texts by providing extensive, up-to-date coverage and introducing the reader to the research literature. Offering comprehensive coverage of all aspects of clinical trials Biostatistics in Clinical Trials: Includes concise definitions and introductions to numerous concepts found in current literature Discusses the software and textbooks available Uses extensive cross-references helping to facilitate further research and enabling the reader to locate definitions and related concepts Biostatistics in Clinical Trials offers both academics and practitioners from various disciplines and settings, such as universities, the pharmaceutical industry and clinical research organisations, up-to-date information as well as references to assist professionals involved in the design and conduct of clinical trials.

✏Book Title : Tutorials in Biostatistics Statistical Methods in Clinical Studies
✏Author : Ralph B. D'Agostino
✏Publisher : John Wiley & Sons
✏Release Date : 2005-09-27
✏Pages : 466
✏ISBN : 9780470023662
✏Available Language : English, Spanish, And French

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✏Tutorials in Biostatistics Statistical Methods in Clinical Studies Book Summary : The Tutorials in Biostatistics have become a very popular feature of the prestigious Wiley journal, Statistics in Medicine (SIM). The introductory style and practical focus make them accessible to a wide audience including medical practitioners with limited statistical knowledge. This book represents the first of two volumes presenting the best tutorials published in SIM, focusing on statistical methods in clinical studies. Topics include the design and analysis of clinical trials, epidemiology, survival analysis, and data monitoring. Each tutorial is focused on a medical problem, has been fully peer-reviewed and edited, and is authored by leading researchers in biostatistics. Many articles include an appendix on the latest developments since publication in the journal and additional references. This will appeal to statisticians working in medical research, as well as statistically-minded clinicians, biologists, epidemiologists and geneticists. It will also appeal to graduate students of biostatistics.

✏Book Title : The Oxford Handbook of Research Strategies for Clinical Psychology
✏Author : Jonathan S. Comer
✏Publisher : Oxford University Press
✏Release Date : 2013-03-26
✏Pages : 476
✏ISBN : 9780199793655
✏Available Language : English, Spanish, And French

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✏The Oxford Handbook of Research Strategies for Clinical Psychology Book Summary : Mental health problems impose a staggering worldwide public health burden. Regrettably, whereas many sciences have been progressing for centuries (e.g., biology, chemistry) it is only recently that the strategies of science have been applied to the field of clinical psychology. At this relatively early stage in the science of clinical psychology, the majority of work is ahead of us, and as such the prepared investigator must be familiar with the full portfolio of modern research strategies-a set of 'directions' for getting from 'here' to 'there.' To continue to move the science of clinical psychology forward, investigators benefit when they systematically rely on research strategy "routes" that achieve favorable balances between scientific rigor and clinical relevance. With this need in mind, The Oxford Handbook of Research Strategies for Clinical Psychology has recruited some of the field's foremost experts to explicate the essential research strategies currently used across the modern clinical psychology landscape that maximize both precision and significance. Chapters in this volume address design, measurement, and analytic strategies for clinical psychology, including comprehensive coverage of: - effective laboratory methods in experimental psychopathology, single-case experimental designs, small pilot trials, the randomized controlled trial, adaptive and modular treatment designs, and dissemination methods and models - change measurement, observational coding, measurement of process variables across treatment, structural and functional brain imagining, and experience sampling data collection methods - statistical power, correlation and regression, randomized clinical trial data analysis, conventions in mediation and moderation analysis, structural equation modeling, meta-analytic techniques, item-response theory, and the appropriate handling of missing data. The book concludes with an integrative summary of research strategies addressed across the volume, and guidelines for future directions in research methodology, design, and analysis that will keep our young science moving forward in a manner that maximizes scientific rigor and clinical relevance.

✏Book Title : Statistical Monitoring of Clinical Trials
✏Author : Michael A. Proschan
✏Publisher : Springer Science & Business Media
✏Release Date : 2006-12-31
✏Pages : 268
✏ISBN : 0387449701
✏Available Language : English, Spanish, And French

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✏Statistical Monitoring of Clinical Trials Book Summary : The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the Central Limit Theorem shows that test statistics involving very different types of clinical trial outcomes are asymptotically normal, this book shows that the joint distribution of the test statistics at different analysis times is asymptotically multivariate normal with the correlation structure of Brownian motion ("the B-value") – irrespective of the test statistic. Thus, this book offers statisticians an accessible, incremental approach to understanding Brownian motion as related to clinical trials.

✏Book Title : Statistical Testing Strategies in the Health Sciences
✏Author : Albert Vexler
✏Publisher : CRC Press
✏Release Date : 2017-12-19
✏Pages : 703
✏ISBN : 9781315353012
✏Available Language : English, Spanish, And French

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✏Statistical Testing Strategies in the Health Sciences Book Summary : Statistical Testing Strategies in the Health Sciences provides a compendium of statistical approaches for decision making, ranging from graphical methods and classical procedures through computationally intensive bootstrap strategies to advanced empirical likelihood techniques. It bridges the gap between theoretical statistical methods and practical procedures applied to the planning and analysis of health-related experiments. The book is organized primarily based on the type of questions to be answered by inference procedures or according to the general type of mathematical derivation. It establishes the theoretical framework for each method, with a substantial amount of chapter notes included for additional reference. It then focuses on the practical application for each concept, providing real-world examples that can be easily implemented using corresponding statistical software code in R and SAS. The book also explains the basic elements and methods for constructing correct and powerful statistical decision-making processes to be adapted for complex statistical applications. With techniques spanning robust statistical methods to more computationally intensive approaches, this book shows how to apply correct and efficient testing mechanisms to various problems encountered in medical and epidemiological studies, including clinical trials. Theoretical statisticians, medical researchers, and other practitioners in epidemiology and clinical research will appreciate the book’s novel theoretical and applied results. The book is also suitable for graduate students in biostatistics, epidemiology, health-related sciences, and areas pertaining to formal decision-making mechanisms.

✏Book Title : Clinical Trials with Missing Data
✏Author : Michael O'Kelly
✏Publisher : John Wiley & Sons
✏Release Date : 2014-02-14
✏Pages : 472
✏ISBN : 9781118762530
✏Available Language : English, Spanish, And French

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✏Clinical Trials with Missing Data Book Summary : This book provides practical guidance for statisticians, clinicians, and researchers involved in clinical trials in the biopharmaceutical industry, medical and public health organisations. Academics and students needing an introduction to handling missing data will also find this book invaluable. The authors describe how missing data can affect the outcome and credibility of a clinical trial, show by examples how a clinical team can work to prevent missing data, and present the reader with approaches to address missing data effectively. The book is illustrated throughout with realistic case studies and worked examples, and presents clear and concise guidelines to enable good planning for missing data. The authors show how to handle missing data in a way that is transparent and easy to understand for clinicians, regulators and patients. New developments are presented to improve the choice and implementation of primary and sensitivity analyses for missing data. Many SAS code examples are included – the reader is given a toolbox for implementing analyses under a variety of assumptions.

✏Book Title : Analysis of Clinical Trials Using SAS
✏Author : Alex Dmitrienko
✏Publisher : SAS Institute
✏Release Date : 2017-07-17
✏Pages : 410
✏ISBN : 9781635261448
✏Available Language : English, Spanish, And French

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✏Analysis of Clinical Trials Using SAS Book Summary : Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly used methods are covered, including dose-escalation and dose-finding methods that are applied in Phase I and Phase II clinical trials, as well as important trial designs and analysis strategies that are employed in Phase II and Phase III clinical trials, such as multiplicity adjustment, data monitoring, and methods for handling incomplete data. This book also features recommendations from clinical trial experts and a discussion of relevant regulatory guidelines. This new edition includes more examples and case studies, new approaches for addressing statistical problems, and the following new technological updates: SAS procedures used in group sequential trials (PROC SEQDESIGN and PROC SEQTEST) SAS procedures used in repeated measures analysis (PROC GLIMMIX and PROC GEE) macros for implementing a broad range of randomization-based methods in clinical trials, performing complex multiplicity adjustments, and investigating the design and analysis of early phase trials (Phase I dose-escalation trials and Phase II dose-finding trials) Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience and the ready-to-use SAS macros compiled in this book.

✏Book Title : Case studies in Bayesian statistics 6 2002
✏Author : Constantine Gatsonis
✏Publisher : Springer Science & Business Media
✏Release Date : 2002-08-12
✏Pages : 376
✏ISBN : 0387954724
✏Available Language : English, Spanish, And French

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✏Case studies in Bayesian statistics 6 2002 Book Summary : This volume contains invited case studies with the accompanying discussion as well as contributed papers selected by a refereeing process of 6th Workshop on Case Studies in Bayesian Statistics was held at the Carnegie Mellon University in October, 2001.

✏Book Title : Methods and Applications of Statistics in Clinical Trials Volume 2
✏Author : N. Balakrishnan
✏Publisher : John Wiley & Sons
✏Release Date : 2014-06-16
✏Pages : 960
✏ISBN : 9781118595961
✏Available Language : English, Spanish, And French

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✏Methods and Applications of Statistics in Clinical Trials Volume 2 Book Summary : Methods and Applications of Statistics in Clinical Trials,Volume 2: Planning, Analysis, and Inferential Methods includesupdates of established literature from the Wiley Encyclopedia ofClinical Trials as well as original material based on the latestdevelopments in clinical trials. Prepared by a leading expert, thesecond volume includes numerous contributions from currentprominent experts in the field of medical research. In addition,the volume features: • Multiple new articles exploring emerging topics, such asevaluation methods with threshold, empirical likelihood methods,nonparametric ROC analysis, over- and under-dispersed models, andmulti-armed bandit problems • Up-to-date research on the Cox proportional hazardmodel, frailty models, trial reports, intrarater reliability,conditional power, and the kappa index • Key qualitative issues including cost-effectivenessanalysis, publication bias, and regulatory issues, which arecrucial to the planning and data management of clinical trials

✏Book Title : Translational Medicine
✏Author : Dennis Cosmatos
✏Publisher : CRC Press
✏Release Date : 2008-12-17
✏Pages : 224
✏ISBN : 1584888733
✏Available Language : English, Spanish, And French

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✏Translational Medicine Book Summary : Examines Critical Decisions for Transitioning Lab Science to a Clinical Setting The development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting such treatments approved for marketing and to the patients is decreasing. As a result, translational medicine (TM) is becoming increasingly important in the healthcare industry – a means of maximizing the consideration and use of information collected as compounds transition from initial lab discovery, through pre-clinical testing, early clinical trials, and late confirmatory studies that lead to regulatory approval of drug release to patients. Translational Medicine: Strategies and Statistical Methods suggests a process for transitioning from the initial lab discovery to the patient’s bedside with minimal disconnect and offers a comprehensive review of statistical design and methodology commonly employed in this bench-to-bedside research. Documents Alternative Research Approaches for Faster and More Accurate Data Judgment Calls Elaborating on how to introduce TM into clinical studies, this authoritative work presents a keen approach to building, executing, and validating statistical models that consider data from various phases of development. It also delineates a truly translational example to help bolster understanding of discussed concepts. This comprehensive guide effectively demonstrates how to overcome obstacles related to successful TM practice. It contains invaluable information for pharmaceutical scientists, research executives, clinicians, and biostatisticians looking to expedite successful implementation of this important process.

✏Book Title : Biotechnology and Biopharmaceuticals
✏Author :
✏Publisher : John Wiley & Sons
✏Release Date : 2013-09-19
✏Pages : 744
✏ISBN : 9781118659984
✏Available Language : English, Spanish, And French

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✏Biotechnology and Biopharmaceuticals Book Summary : Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

✏Book Title : Statistical Approaches in Oncology Clinical Development
✏Author : Satrajit Roychoudhury
✏Publisher : CRC Press
✏Release Date : 2018-12-07
✏Pages : 220
✏ISBN : 9781351650472
✏Available Language : English, Spanish, And French

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✏Statistical Approaches in Oncology Clinical Development Book Summary : Statistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development. It illustrates how novel statistical methods can enrich the design and analysis of modern oncology trials. The authors include many relevant real life examples from the pharmaceutical industry and academia based on their first-hand experience. Along with relevant references, the book highlights current regulatory views. The book covers all aspects of cancer clinical trial starting from early phase development. The early part of the book covers novel phase I dose escalation design, exposure response analysis, and innovative phase II design. This includes early development strategy for cancer immunotherapy trials. The contributors also emphasized the role of biomarker and modern era of precision medicine. The second part focuses on the late stage development. This includes the application of adaptive design, safety analysis, and quality of life (QoL) data analysis. The final part discusses current regulatory perspective and challenges. Features: Covers a wide spectrum of topics related to real-life statistical challenges in oncology clinical trials. Provides a comprehensive overview of novel statistical methods to improve trial design and statistical analysis. Detailed case studies illustrate the real life applications. Satrajit Roychoudhury is a Senior Director and a member of the Statistical Research and Innovation group in Pfizer Inc. Prior to joining; he was a member of Statistical Methodology and consulting group in Novartis. He has 11 years of extensive experience in working with different phases of clinical trial. His area of research includes early phase oncology trials, survival analysis, model informed drug development, and use of Bayesian methods in clinical trials. He is industry co-chair for the ASA Biopharmaceutical Section Regulatory-Industry Workshop and has provided statistical training in major conferences including the Joint Statistical Meetings, ASA Biopharmaceutical Section Regulatory-Industry Workshop, and ICSA Applied Statistics Symposium. Soumi Lahiri has 12 years of extensive experience in working different therapeutic areas. She is the former Director of Biostatistics in Clinical Oncology, GlaxoSmithKline. She has also worked in the oncology division of Novartis Pharmaceutical Company for two years. She is an active member of the ASA Biopharmaceutical section and former chair of the membership committee.

✏Book Title : Oncology Clinical Trials
✏Author : Susan Halabi, PhD
✏Publisher : Demos Medical Publishing
✏Release Date : 2009-12-22
✏Pages : 168
✏ISBN : 1935281763
✏Available Language : English, Spanish, And French

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✏Oncology Clinical Trials Book Summary : 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

✏Book Title : Abeloff s Clinical Oncology E Book
✏Author : John E. Niederhuber
✏Publisher : Elsevier Health Sciences
✏Release Date : 2013-09-12
✏Pages : 2224
✏ISBN : 9781455728817
✏Available Language : English, Spanish, And French

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✏Abeloff s Clinical Oncology E Book Book Summary : Practical and clinically focused, Abeloff’s Clinical Oncology is a trusted medical reference book designed to capture the latest scientific discoveries and their implications for cancer diagnosis and management of cancer in the most accessible manner possible. Abeloff’s equips everyone involved - from radiologists and oncologists to surgeons and nurses - to collaborate effectively and provide the best possible cancer care. Consult this title on your favorite e-reader, conduct rapid searches, and adjust font sizes for optimal readability. Select the most appropriate tests and imaging studies for cancer diagnosis and staging of each type of cancer, and manage your patients in the most effective way possible by using all of the latest techniques and approaches in oncology. Enhance your understanding of complex concepts with a color art program that highlights key points and illustrates relevant scientific and clinical problems. Stay at the forefront of the latest developments in cancer pharmacology, oncology and healthcare policy, survivorship in cancer, and many other timely topics. See how the most recent cancer research applies to practice through an increased emphasis on the relevance of new scientific discoveries and modalities within disease chapters. Streamline clinical decision making with abundant new treatment and diagnostic algorithms as well as concrete management recommendations. Take advantage of the collective wisdom of preeminent multidisciplinary experts in the field of oncology, including previous Abeloff’s editors John E. Niederhuber, James O. Armitage, and Michael B. Kastan as well as new editors James H. Doroshow from the National Cancer Institute and Joel E. Tepper of Gunderson & Tepper: Clinical Radiation Oncology. Quickly and effortlessly access the key information you need with the help of an even more user-friendly, streamlined format. Access the complete contents anytime, anywhere at Expert Consult, and test your mastery of the latest knowledge with 500 online multiple-choice review questions.

✏Book Title : The Design and Management of Medical Device Clinical Trials
✏Author : Salah M. Abdel-aleem
✏Publisher : John Wiley & Sons
✏Release Date : 2011-09-09
✏Pages : 268
✏ISBN : 9781118164624
✏Available Language : English, Spanish, And French

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✏The Design and Management of Medical Device Clinical Trials Book Summary : Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate steps to take.

✏Book Title : Statistics Applied to Clinical Trials
✏Author : Ton J. Cleophas
✏Publisher : Springer Science & Business Media
✏Release Date : 2003-01-31
✏Pages : 226
✏ISBN : 1402010966
✏Available Language : English, Spanish, And French

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✏Statistics Applied to Clinical Trials Book Summary : The current book can be studied together with the texbook Statistics Applied To Clinical Trials by the same authors, or separately. The authors often hear that students have difficulties in understanding statistics from a textbook and that self-assessment through exercises and examples is required. Rather than trying to be complete, this book focuses on the main aspects, including the test statistics generally used for the primary analysis of continuous and proportional data from randomized controlled clinical trials. In the past few years statistical analysis has increasingly been left to the computer, and clinical investigators are at a loss to understand the limitations of the research and its statistical analysis, on the one hand, while on the other hand, statistical results are often overemphasized. This self-assessment book is not only useful for investigators involved in the field of clinical trials, but also for every physician who wishes to better understand the data from trials as published currently.

✏Book Title : Randomised Controlled Clinical Trials
✏Author : Christopher J. Bulpitt
✏Publisher : Springer Science & Business Media
✏Release Date : 2013-04-17
✏Pages : 262
✏ISBN : 9781475763584
✏Available Language : English, Spanish, And French

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✏Randomised Controlled Clinical Trials Book Summary : Bradford Hill has defined a clinical trial as "A carefully and ethically designed experiment with the aim of answering some precisely framed question" [1]. This definition specifies a careful design and requires the provision of adequate controls. Random allocation of treatments to subjects is important to ensure is entitled that the treated and control groups are similar. Therefore this book Randomised Controlled Clinical Trials. We can define a randomised controlled trial by rewriting Bradford Hill's definition as follows, "A carefully and ethi cally designed experiment which includes the provision of adequate and ap propriate controls by a process of randomisation, so that precisely framed questions can be answered. " I am a firm advocate ofRandomised Controlled Clinical Trials but intend to give a balanced view of the advantages and disadvantages of these ethical experiments. This book is directed primarily at the medical research worker, although certain chapters may find a wider application. When discussing a randomised controlled trial, it is neither practicable nor desirable to divorce theory from practice, however the first ten chapters con centrate mainly on theory, and the remainder focus on practice. The segment on trial design is followed by sections on writing the protocol, designing the forms, conducting the trial, and analysing the results. This book is meant to serve both as a reference manual and a practical guide to the design and performance of a trial.

✏Book Title : Statistical Thinking for Non Statisticians in Drug Regulation
✏Author : Richard Kay
✏Publisher : John Wiley & Sons
✏Release Date : 2014-11-17
✏Pages : 368
✏ISBN : 9781118470947
✏Available Language : English, Spanish, And French

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✏Statistical Thinking for Non Statisticians in Drug Regulation Book Summary :

✏Book Title : Platform Trial Designs in Drug Development
✏Author : Zoran Antonijevic
✏Publisher : CRC Press
✏Release Date : 2018-12-07
✏Pages : 304
✏ISBN : 9781351683937
✏Available Language : English, Spanish, And French

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✏Platform Trial Designs in Drug Development Book Summary : Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible. The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as quantum computing, patient’s rights to information, and international health. The book begins with an overview of platform trials from multiple perspectives. It then describes impacts of platform trials on the pharmaceutical industry’s key stakeholders: patients, regulators, and payers. Next it provides advanced statistical methods that address multiple aspects of platform trials, before concluding with a pharmaceutical executive’s perspective on platform trials. Except for the statistical methods section, only a basic qualitative knowledge of clinical trials is needed to appreciate the important concepts and novel ideas presented.