[Minutes, Advisory Committee to the Director GP-160 Meeting (1992: Bethesda, Maryland)]

162

1 And will you just follow them up in a very simple
2 protocol?"
3 So, in fact, compared to a traditional
4 trial, representativeness of different populations,
5 whether by race, by gender, by age, by risk groups,
6 are actually better in a large, simple trial.
7 And if, for some reason, you feel you're
8 still not getting the right mix, you can over-sample.
9 You can let your trial run for an extra six months in
10 a given strata to give you an answer.
11 And since it's simple, it's not costing
12 you $10,000 a patient. It's only costing you five
13 dollars a patient.
14 CO-CHAIRMAN CARPENTER: Thank you, Dr.
15 Yusuf.
16 DR. BROWN: I feel compelled first to --
17 I think we need to be clear about the data. When we
18 talk about a large, simple trial -- and you asked the
19 question -- in the context of HIV, what's the best
20 example that we have of a large simple trial? I don't
21 think we do. The thing that's closest to it was the
22 expanded access for DDI.
NEAL R. GROSS
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