Table 1.

Challenges in protocol design and implementation

Challenges	Implemented or proposed solutions
Ensuring drug supply across a global network of sites	• Request for waiving of relabelling requirements  • Centralised drug management and distribution through two drug depots  • Pragmatic registration and activation  • Use of centralised pharmacies to serve multiple sites
Data and sample collection during a pandemic	• Reducing reporting burden through the use of protocol specified exempt events  • Attempting to balance safety reporting with burden on site staff  • Phone visits for discharged patients  • Use of contractors for post-discharge sample collection
Regulatory approval and study implementation outside the U.S.	• Sharing of regulators responses across the network  • Use of a master protocol design with all new agent specific changes in an appendix  • Mechanism to allow communication between relevant agencies in different countries