I wanted to clarify something Dr. Patterson is wri

I wanted to clarify something Dr. Patterson is writing the prescriptions.
Am I wrong wasn’t the choice of the members of the DSMB made by the company?

Can dosing and route of administration be considered a violation of trial design.

If increased doses are proposed for a change in trial design, could the FDA, ask to repeat phase1/2 to determine safety at the higher dosing?

I think a change in the route of administration, which probably would have been granted . Moreover Dr. Patterson’s paper showed onset of action was around 3 days (probably due to poor absorption in critical patients) a lot of time for the study group to have advanced disease. IV would have immediate action.

I have used the example of insulin in the ICU. Translating the out patients HIV experience to the ICU perhaps was not a good idea in trial design. Maybe to keep the mantra that there is an advantage in not having to start an IV??. The average patient in the unit may have 6-8 IV’s in already. I think if an intensivist was involved CD-12 would be different and perhaps be more successful.