[mbreese]

On further thinking, I'm not even sure what happens in the case of a patient receiving a pre-approval drug outside of the trial. Handling their data would likely need to meet the same standards required in trial (consent tracking, electronic signatures, etc) without any of the machinery of the trial to help. It could well be the case that nothing is collected if the cost to keep it and use it are too high.

IIRC, some of this was handled by FDA (or could have been), if they were part of the process by granting an unapproved treatment waiver. This way some amount of 'informal' data could be collected and used to guide others, even if the treatment was outside of a formal trial. Now, without FDA having a role, I fear that none of this data will be captured (or at least not in a useable form).