I went looking for an updated protocol on the ANZCTR website today. The data there is out of date. It says it was updated 22/3/2021 (so a week ago) but if you click on the little i for information button next to "Date last updated" then you read that that is not the date they received updated info from the registrant like CYP (Killian or whoever) its the date some staffer at ANZCTR updated the info after they got a request to update the info from the registrant.
Its perfectly possible to find the MEND trial on the ANZCTR website - and that is where the up to date protocol should be able to be found in my opinion. But there are two types of human involvement that mean that the info is out of date. The humans at CYP and the humans at ANZCTR both of whom are likely to be quite okay with out of date info being displayed - as it currently is. Both types of human are working on the trust us and "we appreciate your patience" (that's a quote from the ANZCTR website after "COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience". We aren't really given much choice but patience by ANZCTR and we aren't really given much choice but to trust Ross and Killian will get the trial design right by Ross and Killian.
It is not the hospitals ICU bed capacity that is the issue for how long to get patients - its the entire number of hospitals - there are now at least four - westmead, kingwood, footscray, st albans - and also the key exclusion criteria that need to be examined to know the key exclusion criteria. The current protocol as described still contains the words "with COVID-19 being treated in intensive care units" so its not up to date enough to be of any practical use.
But here is the URL.
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379838&showHistory=true&isReview=true
For patients to get the treatment they have to get through all the filters of the key exclusion criteria and do that at one of the hospitals that can take them.
Unfortunately, in my opinion, its ignorance of what is involved, that lets Ross and increasingly Killian who seems to have learned Ross's style of communication, get away with stuff they shouldn't be able to get away with. Progress is pretended rather than real.
Without an actual protocol how can shareholders know whether the 24 patients that are now to be recruited (we hope) will be statistically sufficient to power a meaningful result given that the patients will have had different reasons for getting ARDS like symptoms?
Its like there are additional potentially confounding variables now in the patient number which is the same 24 only half of which were to get cells. That's just 12 positive test cases.
I think we are being essentially asked to trust that Ross and Killian will get the details right on the trial - but we aren't actually being given any specific assurances because we don't have the protocols either in the announcements or on the ANZCTR website.
In my opinion Ross and Killian didn't get the details right the first time and we have had a trial that didn't go anywhere. By the details I mean they don't seem to have gamed out whether there could be sufficient numbers of patients getting through the screening criteria before they went ahead and incurred expenses.
I'm concerned now that 24 won't be enough to statistically power any result - that potential partners who might have been interested in a statistically powered result won't be impressed enough.
In short, in my opinion, Ross and Killian, are, it seems, using shareholders funds to discover how to do this clinical trial stuff - they are learning by doing. They aren't it seems experienced hands. In my opinion. And their shareholders are too complacent to hold them to account. The sort of interviews Ross does with folk like Dr Boreham who says he isn't a Dr but makes wisecracks about his outfit suggests Ross is targeting a demographic of shareholder that is far from the sharpest knives in the drawer.
In my world (just someone who has done some management and some planning - nothing special) - working out whether to incur substantial new expenses in the first place is part of management planning. A poor design is never going to work so you don't try to implement a holy mary and then claim it was beyond your control. In Ross and Killian's world it seems that things fall into the lets set up a trial and see how things go and then modify it and then spin something out to the shareholders.
Maybe I'm being harsh, but its how I see things and its sincere.
(20min delay)