Thread by @ABatemanHouse

@azlawhealth & #CUPAEthics & @JLME_ASLME joint webinar on real world data from #ExpandedAccess (using #ConvalescentPlasma as a treatment for #COVID19 as a case study) featuring @DrMJoyner @tomwatson83a @HollyLynchez @ClaudiaHirawat @trsklar & more on now!

@DrMJoyner the convalescent plasma being used was an “uncharacterized product at unknown dose”

Many sites where convalescent plasma was used via Expanded Access were not habituated to clinical trials; would have been a massive lift to run a trial site there. Question is why sites more familiar with trials weren’t “peeled off” over time; we tried

Prof Hayley Belli (NYU Biostatistics): expanded access not a trial; without randomization & control arm -key features of drawing causal inference-challenging to determine impact of treatment with convalescent plasma

This large EA program provides real world data that can help design clinical trials that are needed for proving causation

@HollyLynchez Expanded Access may not interfere with trial enrollment. FDA could have, as watching # of pts in EAP rise, say this no longer meets regulatory criteria & we will stop it, forcing hand of funders to fund trials

BARDA paid for the EAP; maybe they should have funded trials. Missed opportunity. Way to address pandemic is to get evidence-based treatments as soon as possible, not just throw things at people

@ClaudiaHirawat difficult situation for patients offered opportunity to use convalescent plasma. No COVID19 patient group to provide advice. Very hard to get 2nd opinion while in hospital. Sick, scared

Belli: always look at data for trends; question of how generalizable

@DrMJoyner example of situation in which time to treatment is crucial; are trials appropriate in all situations?

@DrMJoyner I had no idea how diffuse the blood banking system is when I started this; BARDA holds EUA for convalescent plasma; non-standardized product; to coordinate all that very different than when dealing with a pharmaceutical product

Thank you 🙏🏻🙏🏻🙏🏻 to all panelists & hosts for a very interesting discussion about utility of real world data collected from #ExpandedAccess ! #CUPAEthics @azlawhealth @JLME_ASLME @trsklar @HollyLynchez @DrMJoyner @ClaudiaHirawat @MSageGustafson