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Nick119

10/26/21 7:20 PM

#412323 RE: Nick119 #412322

I should of clarified my question around external controls with;

'have there been any trials where the treatment has become the SOC that have come before us and have leveraged external controls'

flipper44

10/26/21 7:21 PM

#412324 RE: Nick119 #412322

Senti found this a little while ago.

Medidata synthetic control arm lands FDA approval for cancer trial
https://www.outsourcing-pharma.com/Article/2020/11/19/Synthetic-control-arm-lands-FDA-approval-for-cancer-trial


Medidata has helped sponsors run clinical trials for over 20 years, accumulating a clinical trial data repository of 6 million+ patients and 22,000+ trials. This unique data asset enables distinct bene ts over traditional real world data sources.
https://www.medidata.com/wp-content/uploads/2020/11/Acorn-AI-Synthetic-Control-Arm-Fact-Sheet-3.pdf