What bothers me about this is that in principle, before the experiment was done, the FDA has thresholds for acceptance. They already have defined mathematically what level of risk they deem “safe” and what level of effectiveness is “effective enough”. In theory, all the actual data has in it is the possibility of
a. a math error or deliberate mistake or
b. falsification of results
(this is why many have argued that truly independent organizations should run clinical trials)
...it seems like you could build a machine learning tool similar to that used for credit card fraud transaction detection, and hunt for a and b in about a minute of IRL time...
I think we have a misalignment of incentives. The FDA staffs are a few hundred people and they are most likely taking time mainly to avoid risk to their personal reputations and careers. But this extra time is having the consequence of potentially killing tens of thousands of people.
What bothers me about this is that in principle, before the experiment was done, the FDA has thresholds for acceptance. They already have defined mathematically what level of risk they deem “safe” and what level of effectiveness is “effective enough”. In theory, all the actual data has in it is the possibility of
a. a math error or deliberate mistake or
b. falsification of results
(this is why many have argued that truly independent organizations should run clinical trials)
...it seems like you could build a machine learning tool similar to that used for credit card fraud transaction detection, and hunt for a and b in about a minute of IRL time...
I think we have a misalignment of incentives. The FDA staffs are a few hundred people and they are most likely taking time mainly to avoid risk to their personal reputations and careers. But this extra time is having the consequence of potentially killing tens of thousands of people.