30 ms·
> Since 2007, all drug, biologic, and device trials in the US must be registered with ClinicalTrials.gov after phase 1 (which, at least in principle, addresses
by Alex3917 12y ago
> Since 2007, all drug, biologic, and device trials in the US must be registered with ClinicalTrials.gov after phase 1 (which, at least in principle, addresses safety only - not efficacy), and "results" must be reported.
- A substantial percentage of trials haven't reported their results within the required timeframe.
- The number of fines the FDA has levied for non-compliance is zero.
- The data isn't actually published on clinicaltrials.gov, only a brief summary of the results which doesn't really tell you anything.
- As you say, the requirements aren't retroactive.
- There are several large loopholes, e.g. phase IV studies aren't required to be registered.