2014 AEMPS Assessors Training
10-12 Dec. AEMPS
PROFESORADO
José Ríos (Jose.Rios@idibaps.org /Jose.Rios@uab.es)
Ferran Torres (Ferran.Torres@uab.es /Ferran.Torres@uab.es)
Biostatistics and Data Management Core Facility. IDIBAPS – Hospital Clinic Barcelona
Biostatistics Unit. Faculty of Medicine. Universitat Autònoma de Barcelona
EMA: Scientific Advice Working Party (SAWP) & Biostatistics Working Party (BSWP)
PROGRAMA
- Generalidades, porque hace falta la estadística
- Statistical Principles for clinical trials
- Investigation of Subgroups in confirmatory clinical trials
- Adjustment for Baseline Covariates
- Missing data in confirmatory clinical trials
- Application with 1.) Meta-analyses and 2.) One Pivotal study
- Switching between Superiority and Non-inferiority
- Multiplicityissues in Clinical Trials
- Choice of a Non-Inferiority Margin
- Data monitoring committees
MATERIAL (requires password) go=>