RE: The Optimistic View14 Aug 2023 19:29
20 hospitals is typical for late-stage NICE study these days. that would be almost 10% of total neonatal units in England/Wales, so really would be large sample size. NICE will be communicating the finer details of the requirements for this. Obviously running a study with 3 units is vastly different to running a study with just 20 units, so they will need to state this info at some stage. NICE have definitely pushed AIHL down the funnel - so run the study for 3 years with the required number of hospitals, it must be very likely they will then achieve a full NICE recommendation, which would mean NHS hospitals would get funding for to adopt AIHL and would have to do it. that would also then mean regulatory approvals would come easy throughout Europe and US. so the carrot here is definitely real and really does mean something. the only issue is that getting this study completed and then actually getting it reviewed again and approved is going to take some time.....