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RegisterBE: ♀♂ [Design Issues]
posted by Helmut 
– Vienna, Austria, 2020-05-23 19:12 (1284 d 14:33 ago) – Posting: # 21458
Views: 3,194
Salam Loky do,
The FDA requires „subjects from the general population”; hence ~1:1. Though I have seen studies in males only as well. Possibly the ANVISA requires that as well.
AFAIK, in other jurisdictions there are no rules.
See above. I once saw a study were the protocol stated “females and males” and the CRO recruited one female and 15 males. The study was accepted by European agencies but it looked stupid.
See this thread and R-code for stratification there. IMHO, in crossover designs it does not make sense. Do we have “sex” as a factor in the model? No. Do we want to demonstrate BE separate for females and males? Generally not. If yes, we would have to (at least) double the sample size.
Parallel designs are another story, of course. Females/males should be evenly assigned to treatment groups.
❝ […] participants are both males and females, should the ratio between them be 1:1 …
The FDA requires „subjects from the general population”; hence ~1:1. Though I have seen studies in males only as well. Possibly the ANVISA requires that as well.
AFAIK, in other jurisdictions there are no rules.
❝ … or any ratio is accepted, …
See above. I once saw a study were the protocol stated “females and males” and the CRO recruited one female and 15 males. The study was accepted by European agencies but it looked stupid.
❝ … also for randomization procedure is there any special requirements in case both included?
See this thread and R-code for stratification there. IMHO, in crossover designs it does not make sense. Do we have “sex” as a factor in the model? No. Do we want to demonstrate BE separate for females and males? Generally not. If yes, we would have to (at least) double the sample size.
Parallel designs are another story, of course. Females/males should be evenly assigned to treatment groups.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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 studies jag009 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
- Inclusion criteria in BE studies BEQool 2023-05-05 10:42
- Sex-by-treatment interaction Helmut 2023-05-05 12:44
- Sex-by-treatment interaction BEQool 2023-05-11 09:12
- Sex-by-treatment interaction Helmut 2023-05-05 12:44
Ing. Helmut Schütz