Basel Biometrics Section

I am a member of the board of the Basel Biometrics Section (BBS) and also regularly organize events for the BBS.

EFSPI statistical methodology leaders

Together with Cornelia Kunz from Boehringer Ingelheim and Mouna Akacha from Novartis I have initiated the EFSPI statistical methodology leaders group. Find more details here.

Oncology estimand working group

I co-founded and co-lead this group. Find more details here.

SAVVY: Survival analysis for AdVerse events with VarYing follow-up times

The SAVVY project is a consortium of academic and pharmaceutical industry partners that aims to improve the analyses of adverse event (AE) data in clinical trials through the use of survival techniques appropriately dealing with varying follow-up times and competing events. Although statistical methodologies have advanced, in AE analyses often the incidence proportion, the incidence density or a non-parametric Kaplan-Meier estimator are used, which either ignore censoring or competing events. In an empirical study including randomized clinical trials from several sponsor companies, these potential sources of bias are investigated.

Roche has contributed data from three clinical trials to this project. I coordinate the Roche efforts, am actively involved in writing papers within the project, and serve as a member of the SAVVY steering committee.

SAVVY webpage

• Statistical Analysis Plan of SAVVY project
• Estimation of AE risks
• Comparison of AE risk in a two-arm RCT
• R package | github
• Estimating and comparing adverse event probabilities in the presence of varying follow-up times and competing events

NIHR-MRC Trials Methodology Research Partnership (TMRP) Outcomes Working Group: Adverse Events - evaluating harm (lead of estimand workstream)

See here for details.