Parallel: 2×12, Xover: 12 [Regulatives / Guidelines]
Hi Olivbood,
Correct.
Correct, again.
I both cases I would include a bit more subjects to be protected against eventual dropouts. I guess the FDA wouldn’t be amused to get a study in 11 subjects although the guidance clearly states “12 enrolled”.
❝ The guideline specifies that "At a minimum, 12 subjects should be enrolled in each treatment arm." I deduce from it that this is the minimal sample size considering a parallel design study.
Correct.
❝ Alternatively, for a classic 2x2 cross-over study the minimal sample size should be 12 subjects in total since each subject will experience both fed and fasted status.
❝
❝ Is my understanding correct?
Correct, again.
I both cases I would include a bit more subjects to be protected against eventual dropouts. I guess the FDA wouldn’t be amused to get a study in 11 subjects although the guidance clearly states “12 enrolled”.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
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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:
- Minimal Sample Size for Food Effect Study Olivbood 2019-06-14 10:42 [Regulatives / Guidelines]
- Parallel: 2×12, Xover: 12Helmut 2019-06-14 20:43