I was skeptical when I read this yesterday that a medical system with so much money and so many lives on the line could miss something so obvious.
Then today I run across a JAMA article from FDA researchers saying the same thing:
“Failure to determine the most appropriate dose for clinical use was a major reason for nonapproval. Dosing is frequently decided early in drug development, and optimization of doses to maximize efficacy and minimize toxicity is seldom formally explored in phase 3 studies. Adaptive trial designs and other strategies (such as treating phase 3 trial participants with a randomized sequence of different doses) may help to optimize doses.”
Basically, ‘stop making us reject your drugs for stupid reasons like not trying to optimize the dose’.
I was skeptical when I read this yesterday that a medical system with so much money and so many lives on the line could miss something so obvious.
Then today I run across a JAMA article from FDA researchers saying the same thing:
“Failure to determine the most appropriate dose for clinical use was a major reason for nonapproval. Dosing is frequently decided early in drug development, and optimization of doses to maximize efficacy and minimize toxicity is seldom formally explored in phase 3 studies. Adaptive trial designs and other strategies (such as treating phase 3 trial participants with a randomized sequence of different doses) may help to optimize doses.”
Basically, ‘stop making us reject your drugs for stupid reasons like not trying to optimize the dose’.