RE: So Burble!!!!29 Nov 2020 08:43
C7
Back around AGM day I posted some thoughts about the appointment of Dr Gillies and Dr Miller - I'm unsure whether you are able to search my previous posts. But in a nutshell, both are good and I think will help us refine the strategic direction as to where trials are going, what numbers to recruit, the exclusion and inclusion criteria to boost recruitment but also to give a good read out of results at the end.
Reboot of trials is interesting. The Research Ethics Committees are still sitting and in fact IMHO are working very efficiently indeed. Then R&D has to sign off on the trial in each site, this I believe is the sticking point at the moment because of staffing numbers (doctors and other Health care professionals). Many sites have shut down all trials, and are only starting trials they deem as 'high priority'. Different sites have different criteria for this, but I would hope one of these criteria is patients who would benefit most (e.g. patients who have run out of other treatment options). Some sites are also restarting trials which have a low time burden - e.g. which are using standards of care seen else where, or where there is limited need for hands on time.
To get any trial open in a site is a lot of work and ultimately comes down to R&D sign off and staff. Different hospitals will see differing pressures at the moment, so it's difficult to say in a general way how to reboot trials across the board. I know there is a big push in our local hospital to get trials back on track, but even that is taking a while. For instance I submitted a substantial amendment to our local NHS Trust R&D for a study which uses relatively little nursing time and fits into the standard of care for our patients. We're a month down the line and that hasn't been approved yet, even though it basically is a paper change to the protocol and was partially designed to significantly reduce the actual amount of nursing time needed to complete it. In comparison, across the other 20 hospitals we are involved with, 3 have said 'not a covid study, so not even looking at this until Covid is over', another 8 it's stuck with R&D and the other 9 approved it within a week. So very much dependent on hospitals and where their priorities are unfortunately.
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