Posted by yxibow on September 7, 2009, at 4:10:07
In reply to Re: Clinical trials.gov - to yxibow, posted by meltingpot on September 7, 2009, at 3:35:53
> Hi,
>
> Thanks for your response. If that is the case then I cannot understand why they put trials on there to start with if they don't enter the results. There is a section on the Clinical trials site for them to put the results but they don't seem to bother.
>
> Denise
This may better explain some of ithttp://clinicaltrials.gov/ct2/info/results
If a trial never proceeded beyond Phase I (testing of a compound on a small, typically I think 10-12, set of 'control' or 'healthy' individuals, i.e. those who have no relevant background disorders related to the indication of the drug and generally no serious or terminal health conditions), reports may not be legally required to be filed.
A Phase I is literally taking a compound that has come out of the lab, has been extensively worked up in synthesis and computer models, has been tested on appropriate animal subjects, and administering it to "healthy" subjects as complete controls to test for adverse reactions in humans, period.
As for the somewhat expanded, Phase II, and the multinational (typically) Phase III trials, those appear to have a year for their results to be examined and filed, and may apply for additional time under some circumstances, at least having giving a cursory look at the rules I saw there.
-- tidings
poster:yxibow
thread:915891
URL: http://www.dr-bob.org/babble/20090902/msgs/915978.html