Download An example of planning a clinical phase III program: A biostatistical

Tuesday, November the 11th, 2012, at 10.00 at the Pharmaceutical Faculty,
University of Copenhagen.
Expert lecture in the course “Statistical Design and Analysis of Experiments”
Philip Hougaard
Lundbeck
An example of planning a clinical phase III program: A biostatistical experience.
Abstract
Planning a clinical phase III program for developing a drug candidate is a complex
task involving contributions from many scientific disciplines.
This talk will highlight this, as seen from a biostatistician’s viewpoint. On the one
hand, it is necessary with an understanding of “hard issues”, that is, the statistical
methods including corresponding sample size calculations.
On the other hand, it is also necessary with an understanding of other scientific
disciplines involved in the clinical studies, like the medical aspects, as well as the
operational issues in running clinical trials. On top of this, the authorities, such as
EMA and FDA, must be taken into account.
The talk will be illustrated with the planning of a phase III development program on a
drug, which is currently in phase III as treatment of stroke.
Philip Hougaard is chief specialist in Biometrics, at H. Lundbeck A/S, where he has
been for 8 years. Before that, he was 17 years at Novo Nordisk. He has an affiliation
as external professor at University of Southern Denmark. He is author of many
scientific papers as well as one book “Analysis of multivariate survival data”.