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Essentials Of A Successful Biostatistical Collaboration
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Book Synopsis Essentials of a Successful Biostatistical Collaboration by : Arul Earnest
Download or read book Essentials of a Successful Biostatistical Collaboration written by Arul Earnest and published by CRC Press. This book was released on 2016-10-14 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this book is to equip biostatisticians and other quantitative scientists with the necessary skills, knowledge, and habits to collaborate effectively with clinicians in the healthcare field. The book provides valuable insight on where to look for information and material on sample size and statistical techniques commonly used in clinical research, and on how best to communicate with clinicians. It also covers the best practices to adopt in terms of project, time, and data management; relationship with collaborators; etc.
Book Synopsis Essentials of a Successful Biostatistical Collaboration by : Luigi Salvay
Download or read book Essentials of a Successful Biostatistical Collaboration written by Luigi Salvay and published by . This book was released on 2017-02 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Mathematical and Statistical Skills in the Biopharmaceutical Industry by : Arkadiy Pitman
Download or read book Mathematical and Statistical Skills in the Biopharmaceutical Industry written by Arkadiy Pitman and published by CRC Press. This book was released on 2019-07-15 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors’ experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development. Discusses differences in the work of a biostatistician in small pharma and big pharma. Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels. Describes some useful statistical background that can be capitalized upon in the drug development enterprise. Explains some hot topics and current trends in biostatistics in simple, non-technical terms. Discusses incompleteness of any system of standard operating procedures, rules and regulations. Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial. Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed. Discusses realistic planning of open-ended projects.
Book Synopsis Medical Biostatistics by : Abhaya Indrayan
Download or read book Medical Biostatistics written by Abhaya Indrayan and published by CRC Press. This book was released on 2017-11-27 with total page 984 pages. Available in PDF, EPUB and Kindle. Book excerpt: Encyclopedic in breadth, yet practical and concise, Medical Biostatistics, Fourth Edition focuses on the statistical aspects ofmedicine with a medical perspective, showing the utility of biostatistics as a tool to manage many medical uncertainties. This edition includes more topics in order to fill gaps in the previous edition. Various topics have been enlarged and modified as per the new understanding of the subject.
Book Synopsis Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing by : Harry Yang
Download or read book Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing written by Harry Yang and published by CRC Press. This book was released on 2016-11-30 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applications of these methods in QbD implementation.
Book Synopsis Statistical Topics in Health Economics and Outcomes Research by : Demissie Alemayehu, PhD
Download or read book Statistical Topics in Health Economics and Outcomes Research written by Demissie Alemayehu, PhD and published by CRC Press. This book was released on 2017-11-22 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: With ever-rising healthcare costs, evidence generation through Health Economics and Outcomes Research (HEOR) plays an increasingly important role in decision-making about the allocation of resources. Accordingly, it is now customary for health technology assessment and reimbursement agencies to request for HEOR evidence, in addition to data from clinical trials, to inform decisions about patient access to new treatment options. While there is a great deal of literature on HEOR, there is a need for a volume that presents a coherent and unified review of the major issues that arise in application, especially from a statistical perspective. Statistical Topics in Health Economics and Outcomes Research fulfils that need by presenting an overview of the key analytical issues and best practice. Special attention is paid to key assumptions and other salient features of statistical methods customarily used in the area, and appropriate and relatively comprehensive references are made to emerging trends. The content of the book is purposefully designed to be accessible to readers with basic quantitative backgrounds, while providing an in-depth coverage of relatively complex statistical issues. The book will make a very useful reference for researchers in the pharmaceutical industry, academia, and research institutions involved with HEOR studies. The targeted readers may include statisticians, data scientists, epidemiologists, outcomes researchers, health economists, and healthcare policy and decision-makers.
Book Synopsis Randomization, Masking, and Allocation Concealment by : Vance Berger
Download or read book Randomization, Masking, and Allocation Concealment written by Vance Berger and published by CRC Press. This book was released on 2017-10-30 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomization, Masking, and Allocation Concealment is indispensable for any trial researcher who wants to use state of the art randomization methods, and also wants to be able to describe these methods correctly. Far too often the subtle nuances that distinguish proper randomization from flawed randomization are completely ignored in trial reports that state only that randomization was used, with no additional information. Experience has shown that in many cases, the type of randomization that was used was flawed. It is only a matter of time before medical journals and regulatory agencies come to realize that we can no longer rely on (or publish) flawed trials, and that flawed randomization in and of itself disqualifies a trial from being robust or high quality, even if that trial is of high quality otherwise. This book will help to clarify the role randomization plays in ensuring internal validity, and in drawing valid inferences from the data. The various chapters cover a variety of randomization methods, and are not limited to the most common (and most flawed) ones. Readers will come away with a profound understanding of what constitutes a valid randomization procedure, so that they can distinguish the valid from the flawed among not only existing methods but also methods yet to be developed.
Book Synopsis Cluster Randomised Trials by : Richard J. Hayes
Download or read book Cluster Randomised Trials written by Richard J. Hayes and published by CRC Press. This book was released on 2017-07-06 with total page 398 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against infectious diseases. Avoiding unnecessary mathematical detail, the book covers basic concepts underlying the use of cluster randomisation, such as direct, indirect, and total effects. In the time since the publication of the first edition, the use of cluster randomised trials (CRTs) has increased substantially, which is reflected in the updates to this edition. There are greatly expanded sections on randomisation, sample size estimation, and alternative designs, including new material on stepped wedge designs. There is a new section on handling ordinal outcome data, and an appendix with descriptions and/or generating code of the example data sets. Although the book mainly focuses on medical and public health applications, it shows that the rigorous evidence of intervention effects provided by CRTs has the potential to inform public policy in a wide range of other areas. The book encourages readers to apply the methods to their own trials, reproduce the analyses presented, and explore alternative approaches.
Book Synopsis Quantitative Methods for HIV/AIDS Research by : Cliburn Chan
Download or read book Quantitative Methods for HIV/AIDS Research written by Cliburn Chan and published by CRC Press. This book was released on 2017-08-07 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quantitative Methods in HIV/AIDS Research provides a comprehensive discussion of modern statistical approaches for the analysis of HIV/AIDS data. The first section focuses on statistical issues in clinical trials and epidemiology that are unique to or particularly challenging in HIV/AIDS research; the second section focuses on the analysis of laboratory data used for immune monitoring, biomarker discovery and vaccine development; the final section focuses on statistical issues in the mathematical modeling of HIV/AIDS pathogenesis, treatment and epidemiology. This book brings together a broad perspective of new quantitative methods in HIV/AIDS research, contributed by statisticians and mathematicians immersed in HIV research, many of whom are current or previous leaders of CFAR quantitative cores. It is the editors’ hope that the work will inspire more statisticians, mathematicians and computer scientists to collaborate and contribute to the interdisciplinary challenges of understanding and addressing the AIDS pandemic.
Book Synopsis Clinical Trial Data Analysis Using R and SAS by : Ding-Geng (Din) Chen
Download or read book Clinical Trial Data Analysis Using R and SAS written by Ding-Geng (Din) Chen and published by CRC Press. This book was released on 2017-06-01 with total page 378 pages. Available in PDF, EPUB and Kindle. Book excerpt: Review of the First Edition "The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it ...The example-based approach is easy to follow and makes the book a very helpful desktop reference for many biostatistics methods."—Journal of Statistical Software Clinical Trial Data Analysis Using R and SAS, Second Edition provides a thorough presentation of biostatistical analyses of clinical trial data with step-by-step implementations using R and SAS. The book’s practical, detailed approach draws on the authors’ 30 years’ experience in biostatistical research and clinical development. The authors develop step-by-step analysis code using appropriate R packages and functions and SAS PROCS, which enables readers to gain an understanding of the analysis methods and R and SAS implementation so that they can use these two popular software packages to analyze their own clinical trial data. What’s New in the Second Edition Adds SAS programs along with the R programs for clinical trial data analysis. Updates all the statistical analysis with updated R packages. Includes correlated data analysis with multivariate analysis of variance. Applies R and SAS to clinical trial data from hypertension, duodenal ulcer, beta blockers, familial andenomatous polyposis, and breast cancer trials. Covers the biostatistical aspects of various clinical trials, including treatment comparisons, time-to-event endpoints, longitudinal clinical trials, and bioequivalence trials.
Book Synopsis Clinical Trial Optimization Using R by : Alex Dmitrienko
Download or read book Clinical Trial Optimization Using R written by Alex Dmitrienko and published by CRC Press. This book was released on 2017-08-10 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation paradigm, as well as supportive R tools, to evaluate and select among simultaneous competing designs or analysis options. It is applicable broadly to statisticians and other quantitative clinical trialists, who have an interest in optimizing clinical trials, clinical trial programs, or associated analytics and decision making. This book presents in depth the Clinical Scenario Evaluation (CSE) framework, and discusses optimization strategies, including the quantitative assessment of tradeoffs. A variety of common development challenges are evaluated as case studies, and used to show how this framework both simplifies and optimizes strategy selection. Specific settings include optimizing adaptive designs, multiplicity and subgroup analysis strategies, and overall development decision-making criteria around Go/No-Go. After this book, the reader will be equipped to extend the CSE framework to their particular development challenges as well.
Book Synopsis Applied Surrogate Endpoint Evaluation Methods with SAS and R by : Ariel Alonso
Download or read book Applied Surrogate Endpoint Evaluation Methods with SAS and R written by Ariel Alonso and published by CRC Press. This book was released on 2016-11-30 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: An important factor that affects the duration, complexity and cost of a clinical trial is the endpoint used to study the treatment’s efficacy. When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate endpoint that can be measured in a more convenient or cost-effective way. This book focuses on the use of surrogate endpoint evaluation methods in practice, using SAS and R.
Book Synopsis Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials by : Toshiro Tango
Download or read book Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials written by Toshiro Tango and published by CRC Press. This book was released on 2017-09-14 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials. The author introduces a new repeated measures design called S:T design combined with mixed models as a practical and useful framework of parallel group RCT design because of easy handling of missing data and sample size reduction. The book emphasizes practical, rather than theoretical, aspects of statistical analyses and the interpretation of results. It includes chapters in which the author describes some old-fashioned analysis designs that have been in the literature and compares the results with those obtained from the corresponding mixed models. The book will be of interest to biostatisticians, researchers, and graduate students in the medical and health sciences who are involved in clinical trials. Author Website:Data sets and programs used in the book are available at http://www.medstat.jp/downloadrepeatedcrc.html
Book Synopsis Biosimilar Clinical Development: Scientific Considerations and New Methodologies by : Kerry B. Barker
Download or read book Biosimilar Clinical Development: Scientific Considerations and New Methodologies written by Kerry B. Barker and published by CRC Press. This book was released on 2016-11-25 with total page 269 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.
Book Synopsis Data and Safety Monitoring Committees in Clinical Trials by : Jay Herson
Download or read book Data and Safety Monitoring Committees in Clinical Trials written by Jay Herson and published by CRC Press. This book was released on 2016-12-19 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.
Book Synopsis Essentials of Biostatistics in Public Health by : Lisa M. Sullivan
Download or read book Essentials of Biostatistics in Public Health written by Lisa M. Sullivan and published by Jones & Bartlett Learning. This book was released on 2023-02-28 with total page 407 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essentials of Biostatistics in Public Health, Fourth Edition provides a fundamental and engaging background for students learning to apply and appropriately interpret biostatistics applications in the field of public health. Many examples are drawn directly from the author's remarkable clinical experiences with the renowned Framingham Heart Study, making this text practical, interesting, and accessible for those with little mathematical background. The examples are real, relevant, and manageable in size so that students can easily focus on applications rather than become overwhelmed by computations. The Fourth Edition has been thoroughly updated, and now offers a new chapter on career opportunities in biostatistics and new case studies focused on COVID-19 within each chapter. This edition also includes free access to JMP® Student Subscription (a $29.95 value). New cases based on COVID-19 highlight the importance and practical applications of biostatistics for addressing the pandemic.
Book Synopsis Bioequivalence and Statistics in Clinical Pharmacology by : Scott D. Patterson
Download or read book Bioequivalence and Statistics in Clinical Pharmacology written by Scott D. Patterson and published by CRC Press. This book was released on 2017-03-27 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials. This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.
