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PRINTED BOOKS
Author Bacchieri, Antonella.

Title Fundamentals of clinical research : bridging medicine, statistics and operations / Antonella Bacchieri, Giovanni Della Cioppa.

Published Milano, Italy : Springer, [2007]
©2007

Copies

Location Call No. Status
 UniM ERC  610.72 BACC    AVAILABLE
Uniform title Fondamenti di ricerca clinica. English.
Physical description xxv, 343 pages : illustrations ; 24 cm.
Series Statistics for biology and health.
Statistics for biology and health.
Bibliography Includes bibliographical references (pages [331]-335) and index.
Contents 1 Variability of Biological Phenomena and Measurement Errors 1 -- 1.1 Phenotypic Variability 1 -- 1.2 Temporal Variability 2 -- 1.3 Measurement-Related Variability 3 -- 1.4 Variability of Diagnostic Tests 10 -- 2 Distinctive Aspects of a Biomedical Study. Observational and Experimental Studies 14 -- 2.1 Distinctive Features of Biomedical Studies 14 -- 2.2 Study Protocol 18 -- 2.3 Observational Studies 21 -- 2.4 Experimental Studies 23 -- 3 Observational Studies 28 -- 3.1 Basic Designs of Observational Studies 29 -- 3.2 Bias and Confounding 40 -- 3.3 Advantages and Disadvantages of the Different Types of Observational Studies 53 -- 4 Defining the Treatment Effect 58 -- 4.1 From the Single Measurement to the Signal 58 -- 4.2 Identification and Quantification of the End-Points (Individual Subject Level) 64 -- 4.3 Identification and Quantification of the Signals (Group Level) 69 -- 4.4 Statistical Considerations 70 -- 4.5 Practical, Regulatory, Marketing and Pharmaco-Economic Considerations 73 -- 4.6 Selection and Characterization of the Primary End-Point and Signal: an Example 75 -- 4.7 More Than One Question in the Same Study: the Problem of Multiple Statistical Tests 80 -- 4.8 Validation of Measurement Scales 84 -- 4.9 Special Types of End-Points 85 -- 5 Probability, Inference and Decision Making 90 -- 5.1 Probability 91 -- 5.2 Basic Concepts of Inference 100 -- 5.3 Statistical Inference in the Frequentist and the Bayesian Approaches 106 -- 5.4 Two Digressions: Measures of Variability and Likelihood Function 110 -- 5.5 Frequentist (Classical) Analysis of a Clinical Trial 119 -- 5.6 Bayesian Analysis of a Clinical Trial 138 -- 5.7 Some Additional Considerations on the Frequentist and Bayesian Approaches 146 -- 5.8 Parametric and Non-Parametric Inference 149 -- 5.9 Statistical Decision Making in the Medical Field 150 -- 5.10 Evidence-Based Medicine 152 -- 6 Choice of the Sample 157 -- 6.1 Which Subjects Should Form the Sample? 157 -- 6.2 How Many Subjects Should Form the Sample? 164 -- 7 Choice of Treatments 172 -- 7.1 Study Treatments 172 -- 7.2 Concomitant Treatments 180 -- 8 Experimental Design: Fallacy of "Before-After" Comparisons in Uncontrolled Studies 183 -- 8.1 Experimental Design: Introductory Concepts 183 -- 8.2 Before-After Comparison in a Single Group of Subjects 185 -- 8.3 Temporal Variations of the Disease 186 -- 8.4 Temporal Variations of Staff, Equipment and Environment 188 -- 8.5 Statistical Regression Toward the Mean 189 -- 8.6 Learning Effect 195 -- 8.7 Psychological Effect 196 -- 8.8 Before-After Design Without Control Group in Oncology 197 -- 9 Experimental Design: the Randomized Blinded Study as an Instrument to Reduce Bias 200 -- 9.2 Randomization as Antidote Against Selection Bias 203 -- 9.3 Blinding of Treatments as Antidote Against Assessment Bias 216 -- 9.4 A Priori Definition of the Statistical Methods and Populations as Antidote Against the Analysis Bias 221 -- 9.5 Comparison Between an Observational and an Experimental Study 224 -- 10 Experimenta Designs 228 -- 10.2 Parallel Group Design 233 -- 10.3 Variants of the Parallel Group Design 234 -- 10.4 Other Designs with Comparison Between Subjects: Dose-Escalation and Dose-Titration 244 -- 10.5 Complete Cross-Over Design 247 -- 10.6 Variants of the Cross-Over Design 256 -- 10.7 Other Designs with Within-Subject Comparisons: Simultaneous Treatments and Single Patient Designs 261 -- 10.8 Factorial Designs 263 -- 10.9 Split-Plot Design 271 -- 10.10 Non-Controlled Designs in Phase II Oncology Studies 273 -- 11 Study Variants Applicable to More than One Type of Design: Equivalence Studies, Interim Analyses, Adaptive Plans and Repeated Measurements 277 -- 11.1 Equivalence and Non-Inferiority Studies 277 -- 11.2 Studies with Interim Analyses and Sequential Designs 287 -- 11.3 Adaptive (Flexible) Designs 299 -- 11.4 Studies with Repeated Measurements 301 -- 12 Drug Development Process and the Phases of Clinical sx Research 304 -- 12.1 Overview of the Preclinical Development Process 304 -- 12.2 Phases of Clinical Development 308 -- 12.3 Phases of Clinical Development for Oncology Compounds 322 -- 12.4 Accelerating Clinical Development 325 -- Appendix Areas under the Curve of the Standard Normal Distribution 329.
Summary "This book embraces the three pillars of clinical research: medicine, statistics and operations ('operations' is the logistics of research), and systematically covers the building blocks of a clinical study"--Back cover.
Language notes Translated from the Italian.
Other author Della Cioppa, Giovanni.
Subject Medicine -- Research -- Methodology.
Clinical medicine -- Research -- Methodology.
Medical statistics -- Research.
Biometry -- Research.
ISBN 9788847004917 (hbk.)
8847004918 (hbk.)