The ‘framework for restart’ will be applied to all studies supported by the NIHR, including paused studies and studies in set up that have been adopted onto the Clinical Research Network (CRN) portfolio.
The Framework applies to England, but has been developed in consultation with representatives of the devolved administrations, who may themselves publish analogous guidance in due course.
In order to restart, there are strict guidelines that trials must by shown to still be viable, safe to restart and there must be capacity within the local healthcare system and research management infrastructure to support delivery of the trial.
As capacity may continue to be an issue brain tumour trials that offer urgent treatment, intervention or access to treatments that might not be otherwise available will be considered higher priority. Covid-19 Urgent Public Health Research studies will continue to be prioritised over all other research.
All decisions to restart brain tumour trials will be made on a case by case basis and a restart assessment will be required. This assessment will be coordinated by the lead Local CRN for the study. A timeframe has not been specified for restarting or commencing new studies as this will vary between sites depending on capacity.
We are seeing a real desire in the clinical community to get trials going again with a number of units pushing to do so, as shared at a meeting of the NCRI Brain Tumour Group on Monday.
With this framework in place and that desire, the hope is that we will start to see things restart shortly, although how shortly will depend on the units doing the prioritisation piece over all of their trials.
This is a positive step forward for all our community and those in the wider research and clinical trial landscape during the ongoing COVID-19 crisis.