RE: UNIVERSAL Trial protocol6 Sep 2022 14:28
I have to disagree with timescales that some are putting forward. IMO it should not take too long to recruit 1100 patients in each of 10 sites. They just need to be >18 and have a respiratory infection/or not. Easy target group and we know our A&E departments up and down the country will be full in a couple of weeks, as they have been for the past few years when Winter viruses take hold, and that was pre-Covid.
Secondly, Janssen & Synairgen or J/AZ & Synairgen?, will not need to wait a year or 3 for data. I should think they will have access to a growing body of data in the form of a database (per protocol samples will start to be taken within weeks of first patient) and can analyse trends etc sooner than recruitment end date. As Ghia pointed out a few posts back, there are also some exceptionally qualified people in UoS ,including in other spin-out companies such as TopMD, the precision-medicine focussed phenotyping gurus (who, most interestingly, sent a representative to our AGM too...!! ) that could be leveraged in the UNIVERSAL trial? Although the overall UNIVERSAL trial may take 2 or 3 years, the Janssen-funded bit that Synairgen is collaborating on (the observational study) could in effect yield usable data much sooner than that. One of the secondary objectives remember is cost (cost estimate per patient based on Healthcare Resource Group (HRG) coding at baseline/discharge), and that information should be relatively quick to ascertain.
A PT trial does not need to wait for an observational study to finish. It is my hope that we will be one one or PT PT trials alongside this collaboration with BP.
Just my views to throw into the mix.