What happens when the database is locked?
posted on
Sep 01, 2019 02:47PM
I recall one or more posters here suggesting recently that when the BETonMACE database gets locked, that the analysis and/or results of the analysis don't get revealed until everyone is physically in the same room including mangagment, IR, the clinical steering committee and other primary BETonMACE investigators. I never chimed in. I don't know exactly what is the norm, but personally I do not think this is the way data reveal and analysis has to be done, or is ever done.
The clinical steering committee is comprised of clinicians whose home is in Europe, Australia, and in the USA (CA, IL, NY, CO). Resverlogix is based in Calgary. The lead BETonMACE clinical investigators are scattered around the world with a high concentration in Europe. The timing of the database lock is uncertain. I think (and I could be wrong) that there is also an independent data analysis team (it might be a part of the DSMB) that is also involved in the analysis of the data according to the pre-specified statistical analysis plan. These folks are also not likely in Calgary. The logistics of gathering everyone from around the world together on a moments notice is unlikely and impractical.
Instead, I see two other possibilities.
1) The use of private, secure teleconferencing amongst the key individuals/groups listed above once database is locked and ready for subsequent analysis.
2) If the database is already locked, BETonMACE meeting(s) may be going on before, during, or after the ESC 2019 conference that is going on right now and ends in a few days. ESC is one of, if not the largest, cardiovascular conference in the world. Resverlogix is there. Some (not sure if all) members of the BETonMACE Clinical Steering Committee are there. Some (not sure if all) of the lead clinical BETonMACE investigators from Europe and elsewhere are there. Sure would make for a convenient time for these folk to go behind closed door and have a "little chat."
On that note, Dr. Kausik Ray (the head of the BETonMACE Clinical Steering Committee) is quite a busy man at ESC. Per his recent tweet:
"And so it begins! #ESC2019 is about survival. Leading 2 late breakers, part of 2 more, 10 talks, 2 posters multiple steering committee, ad boards, filming and interviews. Hope to have time to be able to to food and water and find a bathroom."
But like I said above, with teleconferencing options available and many of the interested individuals/parties being scattered around the globe, I personally don't think it is absolutely necessary for folks to all be together physically in the same room.
BearDownAZ