> Although an adaptive design guidance finalized in 2019 left the door open for bayesian trials, their use in drug development has to date been limited,4 such as in Ebola and SARS-CoV-2 epidemics and in pediatric and rare disease trials.
the reason it has been limited to those cases is
drug development, today, is constrained by commercialization.
all four categories listed - ebola, sars-cov-2, pediatric and rare disease drugs - each for their own reason, have low commercialization risk, so if they are scientifically robust solutions, there is ROI.
most drugs in development today are new indications for existing molecules, generally in oncology, also because these are the most favorable conditions for commercialization.
commercialization, commercialization, commercialization. people don't want innovations in drug approval, nobody is clamoring for that. they want innovations in commercialization.
i don't know if bayesian methods will make trials a lot cheaper. and that's their problem! there are already a lot of very smart people working on this issue, and they have litigated to death all the objective facts.
> Although an adaptive design guidance finalized in 2019 left the door open for bayesian trials, their use in drug development has to date been limited,4 such as in Ebola and SARS-CoV-2 epidemics and in pediatric and rare disease trials.
the reason it has been limited to those cases is
drug development, today, is constrained by commercialization.
all four categories listed - ebola, sars-cov-2, pediatric and rare disease drugs - each for their own reason, have low commercialization risk, so if they are scientifically robust solutions, there is ROI.
most drugs in development today are new indications for existing molecules, generally in oncology, also because these are the most favorable conditions for commercialization.
commercialization, commercialization, commercialization. people don't want innovations in drug approval, nobody is clamoring for that. they want innovations in commercialization.
i don't know if bayesian methods will make trials a lot cheaper. and that's their problem! there are already a lot of very smart people working on this issue, and they have litigated to death all the objective facts.