RAP (ASX) Ann: ResApp Provides SMARTCOUGH-C-2 Study Update

Originally posted by largeraj ↑

Hi jono72, that was my first reaction too, lowish numbers given the bad winter.

I'm guessing here, and maybe @MyBentley with his ER experience will have an opinion on this, but I wonder if there is of necessity, a degree of "additional" screening going on, versus last year.

Obviously, patients/carers need to give consent first, to take part in the trial. But on top of that, could it be that there are so many paediatric patients this winter that if ER becomes overloaded and/or patient condition demands immediate treatment, that some/many eligible patients are not given the opportunity to give consent, because it is not practical/possible/ethical to delay their treatment. Just a thought. And I'm assuming that the above does not conflict with clinical trial protocols.

Also, the more rigourous protocols in place this year, might exacerbate the scenario I describe above, ie patients must comply with ALL of the protocols to become eligible, I'm sure that has been drummed into the relevant staff handling the cases.

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The simple answer perhaps is that the C-2 study commenced a full month after the C-1 study.

For the C-1 study, all IRB approvals were received by 16/11/2016 and the study was initiated on 09/12/2016.

For the C-2 study, all IRB approvals were received by 11/01/2018, with first patient enrolled on 08/01 (just prior to approval by Cleveland Clinic Children's).

So given that there was a full month difference (probably due, as you say, to the added complexity of the study protocols this time) the fact that we're 162 patients, or 34% ahead in recruitment this time around is a testament to the leadership being provided, the efforts being put in by the team and of course the high rates of flu this year in the USA.

FWIW, Today....to the very day... marked the 7 month anniversary from "the disaster" of the 9th August last year when we learned that the data had been corrupted/compromised. Whilst the speed of recruitment is of short term importance to us as shareholders in terms of newsflow...it is ALL ABOUT THE QUALITY OF THE DATA. Today the market liked what it saw and it certainly looks as though we are back on the right track.

Giddy up RAP.

The simple answer perhaps is that the C-2 study commenced a full...

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