Add an arm to two way BE study [Design Issues]
Hi Angus,
How about just writing a new protocol, conduct a new study, semi-randomised uncontrolled and with one arm? Invite the same subjects to sign an ICF, use the rand. code from last time. Add arms as you please, to investigate aspects of the food effect.
Technically, I guess this makes certain formalities easier.
You'll end up in possession of data that you can analyse the same way in an exploratory fashion. From a GCP/Helsinki perspective this is "at least as OK" as adding an arm (anticipated benefit and risk same), and the paperwork and struggle with authorities/IRB's may be less. And you can avoid the issue of reconsenting, reopening a database, re-everything.
How about just writing a new protocol, conduct a new study, semi-randomised uncontrolled and with one arm? Invite the same subjects to sign an ICF, use the rand. code from last time. Add arms as you please, to investigate aspects of the food effect.
Technically, I guess this makes certain formalities easier.
You'll end up in possession of data that you can analyse the same way in an exploratory fashion. From a GCP/Helsinki perspective this is "at least as OK" as adding an arm (anticipated benefit and risk same), and the paperwork and struggle with authorities/IRB's may be less. And you can avoid the issue of reconsenting, reopening a database, re-everything.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Add an arm to two way BE study AngusMcLean 2015-07-13 14:47 [Design Issues]
- Add an arm to two way BE study ElMaestro 2015-07-13 17:39
- Add an arm to two way BE study Dr_Dan 2015-07-13 18:00
- Add an arm to two way BE study intuitivepharma 2015-07-15 09:43
- Add an arm to two way BE study AngusMcLean 2015-07-14 00:02
- Add an arm to two way BE study Dr_Dan 2015-07-16 09:18
- Add an arm to two way BE studyElMaestro 2015-07-16 15:21
- It's all over now d_labes 2015-07-17 08:12
- Add an arm to two way BE study Dr_Dan 2015-07-13 18:00
- Add an arm to two way BE study ElMaestro 2015-07-13 17:39