Biotech Values

[iwfal]

Perhaps iwfal's skepticism is well founded and only those companies already good at running trials would navigate Adaptive Trials efficiently.

This is probably a good way to phrase it - if you are really good at running trials (e.g. rolling out protocols, collecting the correct data, having a lot of data to pre-guess the likely changes you might want for adaptation, ...) AND it is well behaved disease/treatment THEN an Adaptive Trial could buy you something if the part 1 works within expectatons. In which case it saves perhaps 6-12 months "ph 3" execution (not just savings to starting the trial, but bringing on trial sites) - BUT a significant percentage of that savings is going to be eaten in rigorous pre-planning and additional data collecting (e.g. Master's reference to more phase 1 data).

My point being that I am cynical about the touting of it - because:

1) the number of caveats is large and difficult (see list above)

2) before you can successfully implement it you first need to address a whole bunch of other systemic issues (like too small ph iis, like poor site prep and management, ...). And solving those issues will get you 80% of the savings even without Adaptive (if adaptive is even possible).

3) Adaptive comes with some risk. Even when you do everything right and are fairly sure you know what you are likely to choose going forward the part 1 can surprise. And then you've wasted some of the upfront design... .

Finally, my guess is Master and I don't disagree much - that the difference is more about exactly where to draw the lines. In which case I would defer to him because I haven't seen a successful clean(e.g. FDA approval) operationally adaptive trial (seamless I have seen).