24 May 2023, 13:00-18:00
Langenbeck-Virchow Haus, Berlin, Germany 

Conducting human challenge trials: COVID-19 and beyond…

Time pressure on clinical pharmacology in general and on early clinical development in particular, has always been high. The exceptional circumstances associated with the COVID-19 pandemic called for a rethink of how we develop new vaccines and treatments. It pressured the industry into exploring alternative approaches. One of those involved controlled human infection with SARS-CoV-2 to enhance vaccine development.

Although the use of human challenge trials with COVID-19 is a recent and occasionally controversial example of using infectious agents in clinical trials, challenge trials with other viruses, bacteria and even parasites are being employed increasingly as a means of accelerating medicines development.

Apart from infectious challenge trials, the inclusion of several alternate subject ‘challenges’ will be discussed, including: immunological stimulants, challenge agents used in the context of target-engagement models and pain stimuli for the development of new analgesics.

The proposed workshop will consider scientific, methodological, ethical and societal considerations.

We invite participants to take part in lively discussions following the cutting-edge presentations given by our field experts.