Re: Clarification received...
in response to
by
posted on
Jun 09, 2018 03:59PM
A lot of misinformation being spread here. You guys are driving me crazy.
Hartland, this is an event driven trial meaning that the trial stops when 250 adjudicated events have accumulated. That part has not changed. The part that changed is that instead of patients only be dosed for up to 2 years, patients will now be dosed until the end of the trial. Sarah conveyed that longest patient is at 31 months right now. So assuming trial stops by end of year, then this longest patient will have been on drug for around 36 month. However, not all patients will be required to go out to 3 years. As for who is conducting the FA/SSRA at 188 events......the company never explicitly stated this in any communications that I saw, but if one does any reading into clinical trial design, interim analyses and data safety monitoring boards (DSMB), it appears that is is the DSMB that oversees this.
Koo, Sarah explicitly responded "yes" to whether Resverlogix is still blinded. No confusion there. BETonMACE isn't just double blinded, it is triple blinded (Participant, Care Provider, Investigator) according to protocol and DSMB reports. The latter stated in all six of the DSMB reports "Resverlogix, the clinical steering committee, and all investigators remain blinded to the actual safety and efficacy results." Therefore, the Clinical Steering Committee (CSC) is blinded so the CSC would NOT know who is getting apabetalone or placebo!
Fouremm, the RVX science team DOES NOT get regular unblinded data since they are blinded. You even stated as much in your response to Koo! Therefore, the RVX science team WOULD NOT have already analyzed a lot of unblinded data as you suggested since they are blinded! I see you just corrected yourself in a post while I was writing this.
BearDownAZ