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Doubts, page-3

  1. 1,069 Posts.
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    I share some of your concerns but...

    * The flip side of the coin in terms of hospital delays is the fact that they came to us. We didn't have to approach them - it would seem that THEY'RE the eager beavers which bodes well. Sure - the timeline extension is annoying but I'm not familiar with the bureaucracy in US hospitals so maybe someone can chime in? I think we had a poster here who's been on an ethics board before... I would be miffed if management failed to deliver on a due date when they have 100% control of the situation but in this case - perhaps there are exigent circumstances beyond their influence?
    * Reminiscing about my experience in the lab (granted - it was a fair while ago) - it's very difficult to fluke such a positive result consistently. Of course the ability for the software to adapt aided in our impressive standards of accuracy but that was always the advantage we had over standard algos. Did it boost our results? Probably. Does it mean our results are not valid - absolutely not. We need to understand the difference between data accuracy and data integrity. I believe your concerns lies in the possibility that due to the "learning" - our data integrity hasn't been 100% which resulted in a data accuracy that may be challenged during US trials? I see your point and I think it would be good to know if our current results were based on pure "machine learning" during the Oz phase or was there significant human interference in the RAP software as the trials progressed. I don't know exactly how the "learning" occurred or how the algo was tweaked - perhaps someone can offer some intel?
    * fair point - I admit I didn't know that the app creator was the same person analysing the results here locally. That IS something to be avoided when trying to reduce bias (analytical and observer bias are just two I can name pertinent to this situation). Whilst this doesn't mean our data is inaccurate - I can see why your confidence might be a bit shaken.
    * Double blind trials are the keystones of clinical trials - nothing new here. It may be the first time RAP has been challenged like this but it's the standard by which clinical efficacy is measured so I'd expect management is not even a little bit surprised by this procedural norm.
    * Given the OPSEC requirements and "in-country" dynamics of the humanitarian trials - I wasn't expecting much in terms of speedy results. I know it's another delay but there's a lot of moving parts to something this complicated - especially when we've embedded ourselves in a large institution....

    and I'll add another * for myself
    - My main concern is the FDA delay - I know many of us were expecting good movement on that front before Xmas... It is a bit disappointing (reflected in our SP obviously) that it's going to be pushed well into next year but at least it's not due to quantifiable obstacles that we must overcome. If it's only red-tape that we have to contend with: I'm ok with that. And this delay is the very reason I suggested us RAP guys look at another company's official solution to circumvent such an eventuality. Apparently one poster took offense to this very suggestion because they thought a delay was impossible..... and here we are.

    Anyways - good to hear your thoughts Martin.
 
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