Safety evaluation is a key aspect of any medical product development. The aim of this
workshop is to give insights about structuring, analyzing and interpreting safety data from
clinical trials. We will review statistical methods for the analysis of adverse events; methods
for quantifying the risk of false discoveries, discuss conclusions drawn which can be drawn
from the safety analyses and possible consequences.
In the past years, companies have increased their focus on the oversight and prevention of
potential risks impacting individual clinical studies or the overarching clinical program
success by means of subject well-being and protection, data quality and site performance
as well as accuracy and correctness of final study results.
Quantifying the risk-benefit profile of drugs, i.e. characterizing its efficacy and safety, is the
ultimate goal of any drug development program. While statistical inference is routinely used
for the efficacy assessments, safety assessments are often confined to descriptions and
frequency counts. This imbalance in the handling of efficacy and safety should be changed.
Part 1 May 4th: Adverse event types and signal detection
Lecturer: Ekkehard Glimm, Novartis Pharma
Part 2 May 5th: Time-to-event analyses and competing risks for safety data
Lecturer: Prof. Jan Beyersmann, University of Ulm
The seminar is free of charge. However, if you wish to attend, we kindly ask you to fill out
the registration form by 30th April 2021, for organisational reasons. Attendance / log-in
details will be shared in the first days of May.
Please follow this link for the registration: link. In case of issues with the registration tool,
please send an email to laurence.guillier@roche.com.
Slides will be made available after the event on the BBS webpage, pending speaker
approval.