22/12/21 Cynata commences DFU trial
21/04/22 Enrolment of initial patients
29/04/22 Recruitment expected to complete by end of calendar year
27/07/22 End of calendar year
12/10/22 DSMB review
22/11/22 Recruitment expected to complete mid-way through 2023
16/03/23 Added 3 additional trial sites, midway through 2023
21/03/23 Update clinicaltrials.gov, including update to eligibility (not requiring daily change anymore)
06/04/23 Cap Raise presentation, presenting data of 6 (3+3) patients that completed at least 28 day follow up
24/07/23 "Due to an unexpectedly high screening failure rate, which means many potential patients failed to meet the eligibility criteria, the trial has experienced lower than expected enrolment rates." Recruitment now expected to complete end of 2023
26/10/23 Recruitment rate accelerated notably during last quarter
28/12/23 Data to be released of first 16 patients after 10-week follow-up
26/02/24 Data released
08/04/24 Enrolment complete
You said:
"It matters that the change occurred a long way into the trial (when some patients had already been treated in both groups thus (group a - pre-change, group b pre-change) [...]."
Me:
"long time" - granted. But based on the above summary, I don't think the change happened after too many more patients than the first 6, which is the data released 2 weeks later for patients that completed a 28-day follow-up.
Recruitment rate accelerated notably after additional sites and dressing change (previously 6 patients in 12-13 months recruited, then data of 10 additional patients reported that were recruited in about 9-10 months, recruitment accelerated notable after change).
They may have recruited another 2-4 max, leaving you likely with something like 20-22 patients out of 30 left to get data from.
The change was necessary as otherwise we would still be waiting for recruitment to finish and end up with another Neverending AMENDing Story. And neither of us would be happy with that.
In my opinion, it is too early to look at it in such a pessimistic way simply based on "time", without knowing the details. We are better off waiting for the final report before deciding if we lap it up or not. The sky may not be falling afterall.
And talking about a STATISTICALLY SIGNIFICANT difference after 6 or even 16 patients treated (only) after not even completing the required timeframes as per trial protocol, that I would consider an oxymoron that even a moron could sniff from a mile away, not to mention potential partners.
So no, I don't think I missed your point but perhaps I kept my reply a bit too short to bring my point across.
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