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Strategy and Statistics in Clinical Trials

Strategy and Statistics in Clinical Trials
A Non-statisticians Guide to Thinking, Designing, and Executing

by Joseph Tal

  • Publisher : Academic Press
  • Release : 2011
  • Pages : 267
  • ISBN : 0123869099
  • Language : En, Es, Fr & De
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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.

Exam Prep for: Strategy and Statistics in Clinical Trials

Exam Prep for: Strategy and Statistics in Clinical Trials
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2021
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials

Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials
A Book

by Mark Chang,John Balser,Jim Roach,Robin Bliss

  • Publisher : CRC Press
  • Release : 2019-03-20
  • Pages : 362
  • ISBN : 1351214535
  • Language : En, Es, Fr & De
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"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.

Clinical Trial Biostatistics and Biopharmaceutical Applications

Clinical Trial Biostatistics and Biopharmaceutical Applications
A Book

by Walter R. Young,Ding-Geng (Din) Chen

  • Publisher : CRC Press
  • Release : 2014-11-20
  • Pages : 580
  • ISBN : 1482212188
  • Language : En, Es, Fr & De
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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.

Small Clinical Trials

Small Clinical Trials
Issues and Challenges

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

  • Publisher : National Academies Press
  • Release : 2001-02-01
  • Pages : 222
  • ISBN : 0309073332
  • Language : En, Es, Fr & De
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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.

Controversial Statistical Issues in Clinical Trials

Controversial Statistical Issues in Clinical Trials
A Book

by Shein-Chung Chow

  • Publisher : CRC Press
  • Release : 2016-04-19
  • Pages : 611
  • ISBN : 1439849625
  • Language : En, Es, Fr & De
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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.

Handbook for Clinical Research

Handbook for Clinical Research
"Design, Statistics, and Implementation"

by Flora Hammond, MD,James Malec, PhD,Todd Nick,Ralph Buschbacher, MD

  • Publisher : Demos Medical Publishing
  • Release : 2014-08-26
  • Pages : 290
  • ISBN : 1936287544
  • Language : En, Es, Fr & De
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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.

Dose Escalation Strategies for Phase I Clinical Trials with Late-onset Toxicities

Dose Escalation Strategies for Phase I Clinical Trials with Late-onset Toxicities
A Book

by Ying-Kuen K. Cheung

  • Publisher : Unknown Publisher
  • Release : 2000
  • Pages : 125
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Statistical Issues in the Design and Analysis of Clinical Trials

Statistical Issues in the Design and Analysis of Clinical Trials
A Book

by Yanning Liu

  • Publisher : Unknown Publisher
  • Release : 2017-01-11
  • Pages : 248
  • ISBN : 9783659845543
  • Language : En, Es, Fr & De
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Statistical Testing Strategies in the Health Sciences

Statistical Testing Strategies in the Health Sciences
A Book

by Albert Vexler,Alan D. Hutson,Xiwei Chen

  • Publisher : CRC Press
  • Release : 2017-12-19
  • Pages : 703
  • ISBN : 1498730841
  • Language : En, Es, Fr & De
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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.

Translational Medicine

Translational Medicine
Strategies and Statistical Methods

by Dennis Cosmatos,Shein-Chung Chow

  • Publisher : CRC Press
  • Release : 2008-12-17
  • Pages : 224
  • ISBN : 9781584888734
  • Language : En, Es, Fr & De
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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.

Statistical Monitoring of Clinical Trials

Statistical Monitoring of Clinical Trials
A Unified Approach

by Michael A. Proschan,K. K. Gordon Lan,Janet Turk Wittes

  • Publisher : Springer Science & Business Media
  • Release : 2006-12-31
  • Pages : 268
  • ISBN : 9780387449708
  • Language : En, Es, Fr & De
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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.

Clinical and Statistical Considerations in Personalized Medicine

Clinical and Statistical Considerations in Personalized Medicine
A Book

by Claudio Carini,Sandeep M Menon,Mark Chang

  • Publisher : CRC Press
  • Release : 2014-03-27
  • Pages : 376
  • ISBN : 1466593873
  • Language : En, Es, Fr & De
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The Future of Clinical Research and Health Care: From Empirical to Precision Medicine Clinical and Statistical Considerations in Personalized Medicine explores recent advances related to biomarkers and their translation into clinical development. Leading clinicians, biostatisticians, regulators, commercial professionals, and researchers address the opportunities and challenges in successfully applying biomarkers in drug discovery and preclinical and clinical development. Robust Biomarkers for Drug Development and Disease Treatment The first four chapters discuss biomarker development from a clinical perspective. Coverage ranges from an introduction to biomarkers to advances in RNAi screens, epigenetics, and rare diseases as targets for personalized medicine approaches. Subsequent chapters examine the statistical considerations in applying a personalized medicine approach, including multiplicity in pharmacogenomics. The last chapter assesses the regulatory issues involved in using biomarkers. Improve Patient Care and Reduce Costs and Side Effects Despite the vast amount of literature on biomarkers, there is no comprehensive book that integrates the clinical and statistical components. This book is one of the first to incorporate both the clinical and statistical aspects of biomarkers in the personalized medicine paradigm. Covering a wide spectrum of personalized medicine-related topics, it presents state-of-the-art techniques for advancing the application of biomarkers in drug discovery and development.

The Design and Management of Medical Device Clinical Trials

The Design and Management of Medical Device Clinical Trials
Strategies and Challenges

by Salah M. Abdel-aleem

  • Publisher : John Wiley & Sons
  • Release : 2011-09-09
  • Pages : 268
  • ISBN : 1118164628
  • Language : En, Es, Fr & De
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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.

Analysis of Clinical Trials Using SAS

Analysis of Clinical Trials Using SAS
A Practical Guide, Second Edition

by Alex Dmitrienko,Gary G. Koch

  • Publisher : SAS Institute
  • Release : 2017-07-17
  • Pages : 410
  • ISBN : 1635261465
  • Language : En, Es, Fr & De
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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.

Statistics In the Pharmaceutical Industry

Statistics In the Pharmaceutical Industry
A Book

by C. Ralph Buncher,Jia-Yeong Tsay

  • Publisher : CRC Press
  • Release : 2019-03-07
  • Pages : 504
  • ISBN : 142005645X
  • Language : En, Es, Fr & De
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The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

Critical Thinking in Clinical Research

Critical Thinking in Clinical Research
Applied Theory and Practice Using Case Studies

by Felipe Fregni,Ben M. W. Illigens

  • Publisher : Oxford University Press
  • Release : 2018
  • Pages : 518
  • ISBN : 0199324492
  • Language : En, Es, Fr & De
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Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all medical specialties.

Proceedings of the Berkeley Symposium on Mathematical Statistics and Probability

Proceedings of the Berkeley Symposium on Mathematical Statistics and Probability
A Book

by Jerzy Neyman,Lucien Marie Le Cam

  • Publisher : Unknown Publisher
  • Release : 1972
  • Pages : 353
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Journal of the American Statistical Association

Journal of the American Statistical Association
A Book

by American Statistical Association

  • Publisher : Unknown Publisher
  • Release : 2009
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Wiley Encyclopedia of Clinical Trials

Wiley Encyclopedia of Clinical Trials
A Book

by Lisa Marie Sullivan,Joseph Massaro

  • Publisher : Wiley-Interscience
  • Release : 2008
  • Pages : 1374
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Here you'll find more than 500 entries from the world's leading experts in the field on the basic concepts, methodologies, and applications in clinical trials. The range of topics includes: basic statistical concepts, design and analysis of clinical trials, ethics, regulatory issues, and methodologies for clinical data management and analysis