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

156

1 a simple answer, even understanding that we have a lot
2 of scientific questions that are unanswered.
3 CO-CHAIRMAN CARPENTER: What you're
4 saying, essentially, is that a large, simple trial is
5 not very simple.
6 Dr. Fauci, would you like to respond to
7 that?
8 CO-CHAIRMAN FAUCI: Not necessarily
9 respond. I just want to perhaps put it in a more
10 simple form, Larry, and see if you agree with this.
11 You're saying, then, that it would
12 obviously be optimal that if we're going to embark on
13 a large trial in which we would hopefully target it
14 such, that we do have representation of different
15 populations of different risk groups, of different
16 ethnic, racial, male/female, et cetera, that since the
17 Phase I trials may not necessarily reflect that broad
18 spectrum, that perhaps we should right away start
19 doing Phase I safety in selected populations to make
20 sure that we don't embark on a trial in which we find
21 out halfway through the large trial that it isn't as
22 safe in one population as another? Is that another
NEAL R. GROSS
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