strategy and statistics in clinical trials a non statisticians guide to thinking designing and executing

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Strategy And Statistics In Clinical Trials

Author : Joseph Tal
ISBN : 9780123869098
Genre : Mathematics
File Size : 53. 71 MB
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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.

Biostatistics For Medical And Biomedical Practitioners

Author : Julien I. E. Hoffman
ISBN : 9780128026076
Genre : Medical
File Size : 26. 97 MB
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Biostatistics for Practitioners: An Interpretative Guide for Medicine and Biology deals with several aspects of statistics that are indispensable for researchers and students across the biomedical sciences. The book features a step-by-step approach, focusing on standard statistical tests, as well as discussions of the most common errors. The book is based on the author’s 40+ years of teaching statistics to medical fellows and biomedical researchers across a wide range of fields. Discusses how to use the standard statistical tests in the biomedical field, as well as how to make statistical inferences (t test, ANOVA, regression etc.) Includes non-standards tests, including equivalence or non-inferiority testing, extreme value statistics, cross-over tests, and simple time series procedures such as the runs test and Cusums Introduces procedures such as multiple regression, Poisson regression, meta-analysis and resampling statistics, and provides references for further studies

Introduction To Statistical Methods For Clinical Trials

Author : Thomas D. Cook
ISBN : 9781584880271
Genre : Mathematics
File Size : 21. 93 MB
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Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.

Designing Clinical Research

Author : Stephen B. Hulley
ISBN : 9781469840543
Genre : Medical
File Size : 34. 9 MB
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Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This product incorporates current research methodology--including molecular and genetic clinical research--and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing.

Clinical Trials

Author : Stuart J. Pocock
ISBN : 9781118794104
Genre : Medical
File Size : 28. 89 MB
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This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience.

Small Clinical Trials

Author : Institute of Medicine
ISBN : 0309171148
Genre : Medical
File Size : 21. 76 MB
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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.

Reading Between The Numbers

Author : Joseph Tal
ISBN : UCSC:32106012552292
Genre : Mathematics
File Size : 42. 87 MB
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This quirky, fast-paced excursion through the world of statistics brings basic statistical concepts down to earth for general readers by showing how statistics are applied in our everyday lives. Drawing on such diverse examples as how pills are manufactured, elections are forecast, and chess tournaments are structured, psychologist Joseph Tal familiarizes readers with variables, means, medians, scales of measurement, sampling, estimating, and other stock-in-trade tools of the statistician. An unusually lively, informal review of statistical concepts Reading Between the Numbers: • Features dozens of fascinating, often whimsical examples drawn from real life and literature, and 100 vivid graphs and tables • Makes statistics fun and easy for general readers interested in numbers • Is the ideal quick-study guide for those who need to learn statistical methods for their jobs • Focuses on the psychology behind statistics, rather than problem-solving• Is based on the author’s popular professional workshops and seminars

Pharmaceutical Statistics Using Sas

Author : Alex Dmitrienko
ISBN : 9781599943572
Genre : Computers
File Size : 31. 19 MB
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Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.

Oncology Clinical Trials

Author : William Kevin Kelly, DO
ISBN : 9780826168733
Genre : Medical
File Size : 68. 66 MB
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The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more Comprehensively covers all regulatory aspects in the pursuit of global oncology trials Digital access to the ebook included

Study Design And Statistical Analysis

Author : Mitchell Katz
ISBN : 9781139643733
Genre : Medical
File Size : 82. 71 MB
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This book takes the reader through the entire research process: choosing a question, designing a study, collecting the data, using univariate, bivariate and multivariable analysis, and publishing the results. It does so by using plain language rather than complex derivations and mathematical formulae. It focuses on the nuts and bolts of performing research by asking and answering the most basic questions about doing research studies. Making good use of numerous tables, graphs and tips, this book helps to demystify the process. A generous number of up-to-date examples from the clinical literature give an illustrated and practical account of how to use multivariable analysis.

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