16 ms·

There have been some changes [1] in recent years attempting to address this. Since 2007, all drug, biologic, and device trials in the US must be registered with

There have been some changes [1] in recent years attempting to address this. 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. There could certainly be some loopholes or limitations on the data release that I am unaware of. However, it is true that most of the controversial, blockbuster drugs that are discussed in the original article were approved long before these requirements came into effect. [1] http://clinicaltrials.gov/ct2/manage-recs/fdaaa http://clinicaltrials.gov/ct2/manage-recs/fdaaa

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.