corsi pre congressuali

18 settembre

dalle ore 09:00 alle ore 17:00
Aula B - Dipartimento Sanità Pubblica e malattie Infettive


Designs for Clinical Trials with Practical Applications

Alessandro Baldi Antognini, Marco Novelli and Maroussa Zagoraiou (University of Bologna)

This course addresses the issue of designing randomized clinical trials for comparing two or more treatments. Particular attention will be placed on adaptive experiments, i.e. sequential trials where the experimenter wishes to make use of the information accrued along the way. Multipurpose optimal allocations of the treatments that achieve a good trade-off between different experimental goals - such as ethics and inferential demands – will be also discussed. Finally, practical implementation of the suggested methodologies will be carried out using R software.


Main topics of the course:

  • Introduction to the design of experiments for clinical trials

  • Local optimality and sequential designs

  • Ethics vs Inference: multipurpose designs and their implementation.



Participants are encouraged to bring their own laptops for the applications. It is recommended to install the free software R and its interface RStudio.




  • Baldi Antognini A., Novelli M. and Zagoraiou M. (2018) Optimal designs for testing hypothesis in multiarm clinical trials. Statistical Methods in Medical Research, available online (doi: 10.1177/0962280218797960)

  • Baldi Antognini A, Giovagnoli A. (2015) Adaptive Designs for Sequential Treatment Allocation. Chapman & Hall/CRC Biostatistics.

  • Rosenberger W.F. and Lachin J.L. (2015) Randomization in Clinical Trials: Theory and Practice, Second Edition. John Wiley & Sons.


Further reading:

  • Baldi Antognini A., Vagheggini A., Zagoraiou M. and Novelli M. (2018) A new design strategy for hypothesis testing under response adaptive randomization. Electronic Journal of Statistics 12: 2454-2481.

  • Network TDRCR (2015) Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. The New England Journal of Medicine 372: 1193–1203.

  • Dworkin R.H., Corbin A.E., Young J.P. et al. (2003) Pregabalin for the treatment of postherpetic neuralgia. a randomized, placebo-controlled trial. Neurology 60: 1274–1283.

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18 settembre

 dalle ore 09:00 alle ore 17:00
Aula Celli - Dipartimento Sanità Pubblica e malattie Infettive

Analysis of Longitudinal Data with Practical Applications

Alessandra Spagnoli and Danilo Alunni Fegatelli (University of Rome)  

The aim of the course is to provide an overview of statistical models for analyzing longitudinal  data. Particular attention will be placed to explore a real longitudinal data set and to distinguish between so-called age and cohort effects. Topic of the course include linear mixed effect models, generalized linear mixed effect models, and handling missing data. The approaches discussed during the course will be implemented using the R software.


Main topics of the course:

  • Introduction to the design of longitudinal  data

  • Model definition, random effect covariance structure, estimation and inference

  • Missing data mechanism, sensitivity analyses



R ( and its interface RStudio, with packages lme4, nlme, ggplot2



  • P Diggle, P Heagerty, K-Y Liang, S Zeger.  Analysis of Longitudinal Data, Oxford:

  • Oxford University Press, 2002

  •  GM FitzmauriceNM LairdJH Ware. Applied Longitudinal Analysis, Wiley-Interscience, New Jersey, 2004

  • RJA Little, DB Rubin. 2002. Statistical Analysis with Missing Data. New York: Wiley. 2nd ed., 2002

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Crediti assegnati: 4

Sessioni accreditate presso il Ministero della Salute:

Sessione Inaugurale

II Sessione plenaria

Per le seguenti figure professionali:

Medico chirurgo (tutte le professioni), Farmacista, Biologo, Odontoiatra, Infermiere.

L’acquisizione dei crediti ECM sarà subordinata a:

1. partecipazione all’intero programma formativo (90% delle ore del corso)

2. consegna del questionario di qualità percepita debitamente compilato e in forma anonima

3. superamento del test di valutazione dell’apprendimento (almeno il 90% delle risposte esatte)

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