Statistics Applied to Clinical Trials
(Sprache: Englisch)
The previous three editions of this book, rather than having been comprehensive, concentrated on the most relevant aspects of statistical analysis. Although well-received by students, clinicians, and researchers, these editions did not answer all of their...
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The previous three editions of this book, rather than having been comprehensive, concentrated on the most relevant aspects of statistical analysis. Although well-received by students, clinicians, and researchers, these editions did not answer all of their questions. This updated and extended edition has been written to serve as a more complete guide and reference-text to students, physicians, and investigators, and, at the same time, preserves the common sense approach to statistical problem-solving of the previous editions.
In 1948 the first randomized controlled trial was published by the English Medical Research Council in the British Medical Journal. Until then, observations had been uncontrolled. Initially, trials frequently did not confirm hypotheses to be tested. This phenomenon was attributed to little sensitivity due to small samples, as well as inappropriate hypotheses based on biased prior trials. Additional flaws were being recognized and, subsequently were better accounted for: carryover effects due to insufficient washout from previous treatments, time effects due to external factors and the natural history of the condition under study, bias due to asymmetry between treatment groups, lack of sensitivity due to a negative correlation between treatment responses etc. Such flaws mainly of a technical nature have been largely implemented and lead to trials after 1970 being of significantly better quality than before. The past decade focused, in addition to technical aspects, on the need for circumspection in planning and conducting of clinical trials. As a consequence, prior to approval, clinical trial protocols are now routinely scrutinized by different circumstantial organs, including ethic committees, institutional and federal review boards, national and international scientific organizations, and monitoring committees charged with conducting interim analyses. The present book not only explains classical statistical analyses of clinical trials, but also addresses relatively novel issues, including equivalence testing, interim analyses, sequential analyses, meta-analyses, and provides a framework of the best statistical methods currently available for such purpose. This book is not only useful for investigators involved in the field of clinical trials, but also for students and physicians who wish to better understand the data of trials as published currently.
Klappentext zu „Statistics Applied to Clinical Trials “
The previous three editions of this book, rather than having been comprehensive, concentrated on the most relevant aspects of statistical analysis. Although well-received by students, clinicians, and researchers, these editions did not answer all of their questions. This updated and extended edition has been written to serve as a more complete guide and reference-text to students, physicians, and investigators, and, at the same time, preserves the common sense approach to statistical problem-solving of the previous editions. In 1948 the first randomized controlled trial was published by the English Medical Research Council in the British Medical Journal. Until then, observations had been uncontrolled. Initially, trials frequently did not confirm hypotheses to be tested. This phenomenon was attributed to little sensitivity due to small samples, as well as inappropriate hypotheses based on biased prior trials. Additional flaws were being recognized and, subsequently were better accounted for: carryover effects due to insufficient washout from previous treatments, time effects due to external factors and the natural history of the condition under study, bias due to asymmetry between treatment groups, lack of sensitivity due to a negative correlation between treatment responses etc. Such flaws mainly of a technical nature have been largely implemented and lead to trials after 1970 being of significantly better quality than before. The past decade focused, in addition to technical aspects, on the need for circumspection in planning and conducting of clinical trials. As a consequence, prior to approval, clinical trial protocols are now routinely scrutinized by different circumstantial organs, including ethic committees, institutional and federal review boards, national and international scientific organizations, and monitoring committees charged with conducting interim analyses. The present book not only explains classical statistical analyses of clinical trials, but
... mehr
also addresses relatively novel issues, including equivalence testing, interim analyses, sequential analyses, meta-analyses, and provides a framework of the best statistical methods currently available for such purpose. This book is not only useful for investigators involved in the field of clinical trials, but also for students and physicians who wish to better understand the data of trials as published currently.
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Inhaltsverzeichnis zu „Statistics Applied to Clinical Trials “
ForewordChapter 1: Hypotheses, Data, StratificationChapter 2: The Analysis of Efficacy DataChapter 3: The Analysis of Safety DataChapter 4: Log Likelihood Ratio Tests for Safety Data AnalysisChapter 5: Equivalence TestingChapter 6: Statistical Power and Sample SizeChapter 7: Interim AnalysesChapter 8: Clinical Trials Are Often False PositiveChapter 9: Multiple Statistical InferencesChapter 10: The Interpretation of the P-ValuesChapter 11: Research Data Closer to Expectation than Compatible with Random SamplingChapter 12: Statistical Tables for Testing Data Closer to Expectation than Compatible with Random SamplingChapter 13: Principles of Linear RegressionChapter 14: Subgroup Analysis Using Multiple Linear Regression: Confounding, Interaction, SynergismChapter 15: Curvilinear RegressionChapter 16: Logistic and Cox Regression, Markow Models, Regression with Laplace TransformationsChapter 17: Regression Modeling For Improved PrecisionChapter 18: Post-Hoc Analysis in Clinical Trials, A Case For Logistic Regression AnalysisChapter 19: ConfoundingChapter 20: InteractionChapter 21: Meta-Analysis, Basic ApproachChapter 22: Meta-Analysis, Review and Update of MethodologiesChapter 23: Crossover Studies with Continuous VariablesChapter 24: Crossover Studies with Binary ResponsesChapter 25: Cross-Over Trials Should Not Be Used To Test Treatments with Different Chemical ClassChapter 26: Quality-Of-Life Assessments in Clinical TrialsChapter 27: Statistics for the Analysis of Genetic DataChapter 28: Relationship among Statistical DistributionsChapter 29: Testing Clinical Trials for RandomnessChapter 30: Clinical Trials Do Not Use Random Samples AnymoreChapter 31: Clinical Data Where Variability Is More Important than AveragesChapter 32: Testing ReproducibilityChapter 33: Validating Qualitative Diagnostic TestsChapter 34: Uncertainty of Qualitative Diagnostic TestsChapter 35: Meta-Analyses of Qualitative Diagnostic TestsChapter 36: Validating Quantitative Diagnostic TestsChapter
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37: Summary of Validation Procedures for Diagnostic TestsChapter 38: Validating Surrogate Endpoints of Clinical TrialsChapter 39: Methods for Repeated Measures AnalysisChapter 40: Advanced Analysis Of Variance, Random Effects and Mixed Effects ModelsChapter 41: Monte Carlo Methods for Data AnalysisChapter 42: Physicians' Daily Life and the Scientific MethodChapter 43: Superiority-TestingChapter 44: Trend-TestingChapter 45: Odds Ratios and Multiple Regression, Why and How to Use ThemChapter 46: Statistics Is No "Bloodless" AlgebraChapter 47: Bias Due to Conflicts of Interests, Some GuidelinesAppendixIndex
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Bibliographische Angaben
- Autoren: Ton J. M. Cleophas , Aeilko H. Zwinderman , Toine F. Cleophas
- 2009, 4th ed., XXII, 562 Seiten, Maße: 23,4 x 15,6 cm, Gebunden, Englisch
- Verlag: Springer Netherlands
- ISBN-10: 1402095228
- ISBN-13: 9781402095221
Sprache:
Englisch
Rezension zu „Statistics Applied to Clinical Trials “
From the reviews of the fourth edition:"Readership: Students, physicians and investigators interested in statistical methods for clinical trials. This book was originally written for a course in medical statistics given in the EU sponsored program European Interuniversity Diploma of Pharmaceutical Medicine starting in the year 2000. ... it has been expanded and updated in order to serve as a guide and reference-text to students, physicians and investigators." (Andreas Rosenblad, International Statistical Review, Vol. 77 (3), 2009)"The book is written for students in health care and physicians and can be viewed as a guide and reference textbook. ... an important contribution to the clinical trials and medical statistics community. ... The book's main strength is its presentation, which deepens the knowledge and understanding of applications of statistical methods and analyses of clinical trials. ... The many good motivating examples make the book a useful resource for instructors teaching introductory statistics courses. I enjoyed reading this book, and you will too." (Technometrics, Vol. 52 (2), May, 2010)
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