18 December 2023: The International Severe Acute Respiratory and emerging Infections Consortium (ISARIC) is working with partners to create a framework to support endpoint selection for clinical trials for outbreak-prone infectious diseases. The project members, which include researchers at ISARIC member networks around the world, are now inviting public feedback on the draft framework.
The framework is designed to support the selection of primary endpoints in Phase III superiority trials for outbreak-prone infectious diseases such as the bubonic plague, mpox, the Crimean-Congo haemorrhagic fever (CCHF) and Lassa fever. The focus of the framework is on endpoint selection for trials that take place in low- and middle-income countries, but it may also be applied in trials that take place in high-income countries. Additional information on the framework can be found here.
What are outbreak-prone diseases?
Outbreak-prone infectious diseases are often:
- have low numbers of sporadic or scattered cases,
- are widely geographically dispersed,
- in locations where there may be limited clinical research facilities in areas with endemic transmission,
- those diseases that have limited evidence to support the selection of clinical trial endpoints
The framework could bring researchers closer to improving clinical trial design to identify a new treatment for these infectioys diseases for wich no other treatment exists or where the current standard of care is considered ineffective.
The feedback process
This call for a public consultation invites feedback on what the framework does well, what could be improved and the limits of its potential application. Those interested in contributing towards the draft process can either provide comments via this online form, or can arrange a short meeting with a member of the project team. The public consultation will remain open until January 31, 2024.