Olivbood
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France,
2019-06-14 08:42

Posting: # 20325
Views: 637
 

 Minimal Sample Size for Food Effect Study [Regulatives / Guidelines]

Hello everyone,

I have a relatively quick question in regards to the FDA guideline "Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations" dated February 2019.

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.
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?

Many thanks,

Olivbood


Edit: Guidance linked. [Helmut]
Helmut
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Vienna, Austria,
2019-06-14 18:43

@ Olivbood
Posting: # 20327
Views: 526
 

 Parallel: 2×12, Xover: 12

Hi Olivbood,

» 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”.

Cheers,
Helmut Schütz
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