The story of our Canadian arm of @boulware_dr 's PEP / Pre-Emptive therapy in a series of tweets. For posterity. This is the story of what clinical research should be like; mind you, I still wish we didn't need coronavirus research @picardonhealth @tomblackwellNP @NightShiftMD
Last week, on #IDTwitter I saw @boulware_dr tweeting about the RCT he was running on hydroxychloroquine prophylaxis in exposed HCW and people exposed to someone in their household. clinicaltrials.gov/ct2/show/NCT04…
I thought it was a brilliant way to do coronavirus trials without exposing research personnel/hospital to patients who may be contagious. I loved the technology aspect. Earlier I had been tweeting at @eliowa about the need for disruption in research during a crisis. This was it!
March 17 - I cold emailed David at 19:00 my time. Asked him about a mirror study in Canada. He replied within hours. We've never met. He said "here is my protocol, feel free to use it" He mentioned some other Canadians had reached out. Gave me some names - the game was afoot
Same night - my wonderful colleagues @DrEmilyMcD and @MatthewPCheng signed on by 10PM EST. Around the same time, I had heard back from @GermHunterMD . Alberta was in. Emailed Greg Drobot and Ryan Zarychanski from Winnepeg. March 18 AM - Manitoba was in. Zoom @ high noon
This went from a cold call email to a 3 province RCT in less than a day. REB applications started. Health Canada application started (because you can prescribe lots of HCQ off-label but to study HCQ properly you need to go through an administrative process and review)
Friday - David's trial is picking up steam! HCQ hits the airwaves due to a political speech. He's doing @GMA abcnews.go.com/GMA/News/video…
6 hours sleep in 2 days. About to submit to Health Canada for PEP, then REB and then sleep. David shares a new protocol to include early Rx.
6 hours sleep in 2 days. About to submit to Health Canada for PEP, then REB and then sleep. David shares a new protocol to include early Rx.
Decision node - sleep... Do one good trial. Or spend hours rewriting? There is no real decision. This is the Manhattan project and we are at war. Sleep can wait. Rewrite Health Canada Submission and REB and submit. Get to work on the logistics that night.
Turning yourself into Amazon for clinical trials doesn't happen instantly. Surprising amount of prep work goes into planning, training, thinking of where things can go wrong and anticipating. Planning HR needs. What type of boxes do we need? Still haven't watched latest Picard
Saturday - early working with developer on getting database David shared imported. Bilingual translations. Testing the logic
Health Canada emails me! Requested some clarifications. Pleasant game of ping-pong with great medical officer over next 12 hours. No rest in sight.
Health Canada emails me! Requested some clarifications. Pleasant game of ping-pong with great medical officer over next 12 hours. No rest in sight.
Building RA training materials. Thinking about who will do the shipping. Review a beautiful study website out of Manitoba. Health Canada officer forwards revisions.
This drug is darned hard to find!
This drug is darned hard to find!
Brief pause for dinner and then update the REB with the latest. Get a reply from the REB co-chair near midnight. Lots of night owls burning the oil! 4am. Time to sleep. Up at 8.
Its a rough day today. Running on fumes. Administrative hurdles looking higher. Health Canada would like some more changes. Moment of near breakdown due to exhaustion. Time for that later. Get the job done and resubmit. Go run around 1800. Eat for the first time today.
Final touches. *If* approved by Health Canada and the REB we could go live Thursday Quebec-wide for this RCT (which is running already in the USA). Will we make the last administrative hurdle? All in 8 days. Incredible. @francoislegault @MinistreMcCann @DrEmilyMcD
Why incredible? Not the short time and the effort of so many. Of course, people will rise to the challenge in this country. No. Incredible because of was *never* said and never really discussed. The true nonsense of science in a pandemic. Money, Authorship, Ownership.
Neither Quebec, Alberta, or Manitoba's teams have received any funding for this study. We are running on good will and small residual budgets. David's study was originally on GoFundMe! It didn't matter. Had to get it done. Patients first. Money later (or never).
So here we are. Ready to get some answers. To take a shot at beating back COVID-19. Our Manhattan project.
Group therapy session over. Thank you.
Post update on RCT ASAP. Quebec/Manitoba will be online first. Alberta next if approved by AHS. Ontario team working on it too
Group therapy session over. Thank you.
Post update on RCT ASAP. Quebec/Manitoba will be online first. Alberta next if approved by AHS. Ontario team working on it too
1700 24th. No communication from REB or health Canada except that they are reviewing....
Spoke with amazing research pharmacy. We can go live as early as tomorrow if (and only if) these other groups approve......
Will update as it unfolds.
Spoke with amazing research pharmacy. We can go live as early as tomorrow if (and only if) these other groups approve......
Will update as it unfolds.
