Ann: Two-Year Results of Phase 1 SR-aGvHD Trial Presented at ISCT, page-7

@Pledge

Does anyone else think it strange to employ a third-party contractor to set up a clinical trial in Australia?

I'm questioning your premise in your question Pledge, what makes you think they have employed a third-party clinical trial contractor in Australia?

IF they have - I could suppose that having one overall international trial manager (contractor or not) might be better from a consistency standpoint especially if there is a lot of blinding going on. My recollection of the trial is that there was a lot of blinding going on. (ie Data packages could be anonymized and passed around - for instance (electronically) how do we stage this according to say some staging criteria?) My recent look at the clinical trial protocol was prompted by Ross's comment to Stuart Roberts (in the video Rossi posted recently) that the breakdown was 30, 30, ie 30 to control arm 30 to test arm, whereas I believe that was once going to be 20 (control arm - why I thought this mattered was because I took it somewhat seriously that recruiting GvHD patients into a trial where they'd be constrained from taking other action for the duration of the trial - which could be the remained of their natural, unpleasant lives, might be a disincentive (Galipeau I think observed of Rethrim at MSB's ODAC that recruitment to placebo is a real issue not just an MSB gripe - my paraphrasing), 40 - so I checked on clinicaltrials.gov for the protocol and that detail was not mentioned either way.

In my opinion Ross and Kilian have stuffed up trials (well one anyway - the MEND trial - that sort of muddied water on three indications - but some data must have been kept somewhere) - but it wouldn't be fair to say Jolanta Airey has in her time at CYP yet - she inherited the MEND trial from Ross and Kilian - in fairness I don't think she gets tarred with the brush of the MEND stuff up. Not in my book anyway.

You wouldn't blame Jolanta Airey for MEND would you?