Fundamentals of Clinical Research Bridging Medicine, Statistics and

The scope of clinical research is to evaluate the effect of a treatment on the evolution of a disease in the human species.The treatment can be pharmacological, surgical, psychological/behavioral or organizational/logistic. The disease, intended as an imp

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Statistics for Biology and Health Bacchieri/Della Cioppa: Fundamentals of Clinical Research Borchers/Buckland/Zucchini: Estimating Animal Abundance: Closed Populations. Burzykowski/Molenberghs/Buyse: The Evaluation of Surrogate Endpoints. Everitt/Rabe-Hesketh: Analyzing Medical Data Using S-PLUS. Ewens/Grant: Statistical Methods in Bioinformatics: An Introduction, 2nd ed. Gentleman/Carey/Huber/Irizarry/Dudoit: Bioinformatics and Computational Biology Solutions Using R and Bioconductor. Hougaard: Analysis of Multivariate Survival Data. Keyfitz/Caswell: Applied Mathematical Demography, 3rd ed. Klein/Moeschberger: Survival Analysis: Techniques for Censored and Truncated Data, 2nd ed. Kleinbaum/Klein: Survival AnalysisL A Self-Learning Text, 2nd ed. Kleinbaum/Klein: Logistic Regression: A Self-Learning Text, 2nd ed. Lange: Mathematical and Statistical Methods for Genetic Analysis, 2nd ed. Manton/Singer/Suzman: Forecasting the Health of Elderly Populations. Martinussen/Scheike: Dynamic Regression Models for Survival Data. Moyé: Multiple Analyses in Clinical Trials: Fundamentals for Investigators. Nielsen: Statistical Methods in Molecular Evolution. Parmigiani/Garrett/Irizarry/Zeger: The Analysis of Gene Expression Data: Methods and Software. Proschan/LanWittes: Statistical Monitoring of Clinical Trials: A Unified Approach. Siegmund/Yakir: The Statistics of Gene Mapping. Simon/Korn/McShane/Radmacher/Wright/Zhao: Design and Analysis of DNA Microarray Investigations. Sorensen/Gianola: Likelihood, Bayesian, and MCMC Methods in Quantitative Genetics. Stallard/Manton/Cohen: Forecasting Product Liability Claims: Epidemiology and Modeling in the Manville Asbestos Case. Sun: The Statistical Analysis of Interval-censored Failure Time Data. Therneau/Grambsch: Modeling Survival Data: Extending the Cox Model. Ting: Dose Finding in Drug Development. Vittinghoff/Glidden/Shiboski/McCulloch: Regression Methods in Biostatistics: Linear, Logistic, Survival, and Repeated Measures Models. Wu/Ma/Casella: Statistical Genetics of Quantitative Traits: Linkage, Map and QTL. Zhang/Singer: Recursive Partitioning in the Health Sciences. Zuur/Ieno/Smith: Analyzing Ecological Data

Antonella Bacchieri Giovanni Della Cioppa

Fundamentals of Clinical Research Bridging Medicine, Statistics and Operations

Antonella Bacchieri Head, Department of Biostatistics and Data Management Research & Development Sigma-tau, Pomezia, Rome (Italy)

Series Editors: M. Gail National Cancer Institute Rockville, MD 20892 USA

A. Tsiatis Department of Statistics North Carolina State University Raleigh, NC 27695 USA

Giovanni Della Cioppa Head, Department of Methodology and Innovation Pharma Development Novartis, Basel (Switzerland)

K. Krickeberg Le Chatelet F-63270 Manglieu France

J. Samet Deparment of Epidemiology School of Public Health Johns Hopkins University 615 Wolfe Street Baltimore, MD 21205-2103 USA

W. Wong Sequoia Hall Department of Statistics Stanford University 390 Serra Mall Stanford, CA 94305-4065 USA

Originally published in Italian: Fondamenti di rice