> Demands for increasingly byzantine trials have ballooned the costs associated with drug development,

Even if that is true, is it an intrinsic problem with trials or just bad regulation? If it is the latter then you need to change the regulations? Is the problem global - is every regulator everywhere demanding byzantine trails?

Regulators don't demand byzantine trials. They'd prefer simpler ones for a million different reasons. Byzantine trial designs exist because it's incredibly hard to prove your drug works even in an RCT. But GP thinks you can just look at EMR data and ta-da now you know, lol.