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Biotech / Medical : Gene therapy
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To: Mike McFarland who wrote (301)6/9/2004 2:31:36 PM
From: Mike McFarland  Read Replies (1) of 319
 
This is not very precise, but suggests
that amending a gene therapy protocol
only involves sending some paperwork to
the FDA.

research.unc.edu

Just scroll down to "amending the protocol"

I will look around on the RAC website too.
www4.od.nih.gov

Now that I think about it, clinical trials are
amended all the time for stuff such as dosing
regimen and perhaps even personal genomics
information (subsets of patients drop out).
edit, sure, that could be a whole thread, and
there seem to be quite a number of messages
posted about amendments--obviously a good place
to start speculating about how a drug is or is
not working when things get rejiggered.

But just how far you can amend, especially with
respect to gene therapy trials might be less clear.
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