
Pre Forum Courses |9 Ottobre|
• Theory and practice for the creation of summary tables using ADaM domains – Programma
• Simulation methods to estimate power and sample size in trial designs with SAS – Programma
Forum Topics |10-11 Ottobre| – Agenda
• Randomization methods and regulatory views
• Dealing with Blinding and Masking
• Study Drug Management
• Innovation in Statistics and next gen statistician role
• Early Phase Clinical Trials
COMITATO SCIENTIFICO
Vincenzo Bagnardi, Università Milano Bicocca
Beatrice Barbetta, Rottapharm Biotech
Marco Costantini, GSK Vaccines
Arturo Lanzarotti, IBSA
Fabio Montanaro, Latis
Giulia Zigon, GSK Vaccines
Le presentazioni sono scaricabili ai seguenti link:
Randomization methods and regulatory views
Chair: Marco Costantini
D. Santoro: Minimization: A Case Study of Covariate-Adaptive Randomization
D. Gregori: Non-randomized clinical trials: modern approaches to exploit their potential
Dealing with Blinding and Masking
Chair: Fabio Montanaro
G. Siri: Double blind, single blind, observer-blind: when and how
K. Bulpitt: The role of the data manager today and future perspectives
V.Torri: Breaking the blind: trade-off between patients’ safety and impact on data integrity
Study Drug Management
Chair: Beatrice Barbetta
M. Artusi: Clinical Trial Supply Manufacturing and Blinding: Challenges and Solutions
R. Benini: Shipment through EDC system (including kit replacement)
C. Bernini: Drug storage at sites
M. Corrado: How a phase 1 clinical trial center is organized
Early Phase Clinical Trials
Chair: Giulia Zigon
P. Mozgunov: An overview of modern dose-finding designs for Phase I clinical trials: Part I
V. Conti: A sample size strategy for a dose-finding study in a multi-valent vaccine: a case study
P. Mozgunov: An overview of modern dose-finding designs for Phase I clinical trials: Part II
G. Tonini: Adaptive design for early stage oncology trials
L. Mariani: Flexible methods for phase II trials
Innovation in Statistics and next gen statistician role
Chair: Arturo Lanzarotti
D. Bottigliengo: Where are we with the Estimands?
T. Padellini – P. Brutti: Wasserstein consensus for Bayesian sample Size Determinations