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

SAS Institute: Review of most common randomization techniques and newest IT solutions for randomization

D. Santoro: Minimization: A Case Study of Covariate-Adaptive Randomization

L. Grassano: Regulatory perspectives on covariate-adaptive randomization methods andpermutation test: theoretical background and implementation using simulations in different study designs

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

B. Pomili: Maintaining the blinding during the trial: monitoring, data review, interim analysis, DSMB, SAEs

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?

S. Gubbiotti – F. De Santis: Bayesian sample size for calibration of approximate intervals in clinical trials

T. Padellini – P. Brutti: Wasserstein consensus for Bayesian sample Size Determinations

F. Ieva: The data analyst in the decision-making process

Resoconto annuale IBIG