Re: BETonMACE Enrollment
in response to
by
posted on
Dec 14, 2017 04:51PM
Just continuing this thread since there's good material in earlier thread posts that might be worth re-visiting.
Over on Stockhouse, G1945V made a statement that I'd like to point out and discuss:
"With respect to end point being available Q4 2018 that would not include any participation from USA seeing that randomization starts Q1 2018 if I am not mistaken. BetOnMace full trials is 104 weeks correct. So the endpoint will certainly not include USA patients."
It sounds to me like G1945V is suggesting that all patients in BETonMACE must be dosed for 104 weeks. This is not and has never been the design of BETonMACE. BETonMACE was originally designed so that patients are dosed for up to 24 months, and the last patients enrolled be dosed for approximately 12 months. This was assuming that the 2400 patient enrollment would be complete around Q4 2017. The average dosing period was projected to be 18 months. It's helpful to think of it in terms of patient years. They were originally aiming for 2400 patients X 18 months = 3600 patient years to achieve the 250 MACE events (based upon the ~11% MACE event rate at 18 months of the EXAMINE trial). There was never a minimum length of time set for dosing of an individual patient. However, the original trial design would have resulted in all patients being on drug for about a year, minimum. The recent discussion of the involvement of US patients may or may not put a wrinkle in this plan.
BearDownAZ