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RegisterInclusion criteria in BE studies [Design Issues]
Hi,
» In BE studies, in case the participants are both males and females, should the ratio between them be 1:1 or any ratio is accepted, also for randomization procedure is there any special requirements in case both included?
You should aim for 1:1 in the protocol but say at least 60:40 split (you can try 70:30 if you are desperate). I do that on my protocols for many yrs and no problem w FDA.
You should randomize w gender as well. I had one CRO who put the first 10 as males and then last 10 as females, lol. No I did not find that funny when I spoke w them.
J
» In BE studies, in case the participants are both males and females, should the ratio between them be 1:1 or any ratio is accepted, also for randomization procedure is there any special requirements in case both included?
You should aim for 1:1 in the protocol but say at least 60:40 split (you can try 70:30 if you are desperate). I do that on my protocols for many yrs and no problem w FDA.
You should randomize w gender as well. I had one CRO who put the first 10 as males and then last 10 as females, lol. No I did not find that funny when I spoke w them.
J
Complete thread:
- Inclusion criteria in BE studies Loky do 2020-05-22 18:16 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE: ♀♂ Helmut 2020-05-23 17:12
- Inclusion criteria in BE studiesjag009 2020-05-25 07:43
- Stratify for sex? Helmut 2020-05-25 12:48
- Stratify for sex? jag009 2020-05-25 21:10
- Stratify for sex? Helmut 2020-05-25 12:48
- Inclusion criteria in BE studies ElMaestro 2020-05-25 14:39
- Inclusion criteria in BE studies Loky do 2020-06-10 13:19
Ing. Helmut Schütz