Posted by Jay2112 on October 6, 2021, at 15:30:35
I was looking through a number of research data sets on new drugs in psychiatry. It seems that often, real world data shows better efficacy than clinical trials.What I do and don't understand is why and how approval of new drugs are not given say a temporary 5 year approval to collect real world data, which in a number of cases for approved drugs, comes out quite differently than the clinical trial data.
So, say safety is the major factor in a temporary approval, and efficacy is so/so, if real world data comes back with better efficacy than the clinical trials, then it would get permanent approval?
Research into new drugs in psychiatry and approval rates are at the bottom say, compared to drugs in cancer research. Let's say the amount of dollars into research to bring a psychiatric drug to approval was cut by 20 percent, as long as safety is not compromised, get the drug out, and let the real world data determine it's further efficacy, and then get an approval or denial.
Point is, we need MANY more drugs, some/most of different mechanisms than current psychiatric drugs. All of us agree???
Humans punish themselves endlessly
for not being what they believe they should be.
-Don Miguel Ruiz-
poster:Jay2112
thread:1117173
URL: http://www.dr-bob.org/babble/20210723/msgs/1117173.html