Box 1 GFBR meeting format

The case studies contained in this Supplement Issue formed the basis of the GFBR meeting and were themed by trial design and method: CRT, SW CRT, adaptive platform and CHIMs. Each session concluded with plenary discussion and was followed by focused small group discussion. The small groups comprised geographically diverse participants so each could learn from the others’ experience and point of view. Two panel sessions were dedicated to policy and guidance: The first session involved an overview of relevant international guidance and responses from a panel that offered regional perspective from East Africa, the Caribbean, Latin America and Southeast Asia. The second panel identified gaps in the guidance and proposed solutions. These included the use of simulation to address concerns about response-adaptive randomisation and to highlight the ethical advantages and disadvantages of the approach. GFBR participants also heard about a funder initiative to create guidance for CHIMs.

GFBR Global Forum on Bioethics in Research, CRT cluster randomised trial, SW stepped wedge, CHIM Controlled human infection model