23 March 2026

Federated trials as opportunity for global collaboration in health emergencies

How can clinical trials in a global health emergency be implemented faster, more coordinated and more effectively?

An international team including DKF research group leader Matthias Briel and postdoc Alain Amstutz presents a new approach for conducting multinational research in exceptional global situations based on an analysis of the global Mpox outbreak in 2022: the federated trial design.

Bundling individual initiatives

After the outbreak of the 2022 Mpox epidemic, the WHO planned a global, randomised study on evaluating the efficacy of tecovirimat. However, its implementation faced insurmountable regulatory, organisational and financial hurdles. Instead, several studies were conducted in parallel, resulting in a considerable fragmentation of resources.

In their analysis, the international team of authors from the UNITY/MPX-RESPONSE and STOMP consortia show how federated study designs can help to pool data in a structured way, plan studies in a harmonised manner and generate evidence that can be used for regulatory purposes - despite separate sponsors and local differences. At the heart of this approach is a common, predefined "Conjoined Analysis Plan", which makes combined data from several parallel studies analysable.

Conclusion

The federated study design is not a substitute, but a strategically important alternative to individual, independent studies, when emergencies or organisational barriers make large multinational studies impossible. It can help to deliver scientifically robust results much faster.