Transcript antonella maniero - Scienze Statistiche

DIPARTIMENTO DI SCIENZE STATISTICHE
Seminar
ASPECTS OF DRUGS DEVELOPMENT AND
STATISTICS
ANTONELLA MANIERO
NOVARTIS PHARMACEUTICAL CORPORATION , USA
December 15, 2014
14.30
Aula Cucconi
Abstract
www.stat.unipd.it/fare-ricerca/seminari
via C. Battisti, 241 - 35121 Padova, Italia - tel +39 049 8274168 - fax +39 049 8274170 - [email protected]
DIPARTIMENTO DI SCIENZE STATISTICHE
UNIVERSITÀ DEGLI STUDI DI PADOVA
ASPECTS OF DRUGS DEVELOPMENT AND STATISTICS
ANTONELLA MANIERO
SENIOR UNIT HEAD BIOSTATISTICS, US SITE HEAD CLINICAL DEVELOPMENT BIOSTATISTICS
BDM ONCOLOGY
NOVARTIS PHARMACEUTICALS CORPORATION
EAST HANOVER, NEW JERSEY, USA
Abstract
In addition to share experience on the role of statisticians in drug
development and in the interaction with Health Authorities around the world,
aspects of statistical methodologies used in clinical trials in drug development
(mainly in oncology) will be shared. Depending on the phase of development
(I to III) and on the mechanism of action of new compounds, as well as
potential targeted effect, sometime novel methodologies need to be
developed. A few critical questions of drug development will be shared and
how these are addressed from the statistical aspects. This includes designing
of phase III studies with futility or efficacy interim analyses in survival setting,
as well as consideration for multiplicity as required by health authorities. In
phase I and II, approaches with Bayesian design are often used at Novartis
and will share a few examples. Furthermore, developing a target therapy there
is need to assess activity in the target as well as in the non-target population
with appropriate techniques to control alpha and the trial design may include
ways of adaptation during the study.
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