The novel, collaborative approach developed by the trial and its NHS partners relies on utilising COVID-19 test result data in a secure and ethical way to ensure eligible participants across the country are contacted about the trial within 24-48 hours of receiving a positive result.
The approach means the PRINCIPLE team are now able to offer potential treatments to suitable participants earlier than if they had found the trial themselves following a recommendation from their clinician. In addition, gaining unique access to a patient Summary Care Record means the trial team can quickly verify that it is safe for each participant to join the trial.
This approach has vastly improved the rate at which eligible patients are recruited into PRINCIPLE and helping the trial platform to become the world’s largest of COVID-19 treatments for recovery at home.
Commenting, Dr Emma Ogburn, Director of Operations for the Primary Care Clinical Trials Unit, said “Last year we needed to rapidly speed up recruitment into PRINCIPLE in such a way that we were getting the right types of patients – those who had only just received a positive COVID-19 test . This group weren’t finding us in the numbers we had hoped. The new approach we developed with Health Data Research UK and our NHS partners has vastly improved uptake, it’s compliant with data privacy laws, and means that more eligible people with COVID-19 can join the trial and help in our search for treatments for recovery at home.”
The PRINCIPLE trial was one of the initial three government priority treatment trials. The NIHR ARC OxTV supported the rapid development of a secure data platform and website when there was considerable uncertainty as to the capacity of some UK infrastructure to cope with COVID., and was also key in the design and distribution of clinician and patient recruitment materials for the PRINCIPLE study; materials which continue to be used nationwide.
The award was won by the RECOVERY trial of COVID-19 treatments for hospitalised patients.