Staburo @ workshop from IBS-DR working group Pharmaceutical Research (APF)

As usual, Staburo took part in the annual workshop of the APF (working group Pharmaceutical Research, of the International Biometric Society German Region) in Berlin on 25 November 2022. After two virtual APF workshops in 2020 and 2021 due to the pandemic situation, this year’s workshop finally took place again as a face-to-face meeting. The get-together evening event on 24 November was hosted by Cytel and it was a great opportunity to meet and discuss with other participants.

This year, the workshop had two parts. The topic of the morning session was “Planning and Estimands for Safety/Benefit-Risk”. The first two talks were about Aggregated Safety Assessment Planning and the trend to move away from isolated safety analyses and single-case evaluation toward benefit-risk assessment planning and a more quantitative approach based on frequency analysis. Other presentations were dealing with safety endpoints for HTA and with the question of what needs to be considered for building an estimand framework for safety.

The afternoon session was dedicated to the topic of “External and Synthetic Control Arms”. Attendees were first introduced to the subject with an overview of the benefits and pitfalls of external data as controls in clinical trials and strategies that can be applied when using external data. This was followed by talks about how multistate models can mitigate the problem of small sample sizes by borrowing information from external control data, and about synthetic control arms in regulatory and HTA assessments.

Many thanks for the great organisation. It was a great workshop, and we are already looking forward to 2023!

Data analysis, clinical biostatistics and more.