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'.
In a world full of irrational people with availability biases, it is likely that seeing the effects of two weak nuclear bombs against Japan helped prevent the use of an arsenal of hydrogen bombs against Korea, Vietnam or the Soviet Union.
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'.