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

160

1 demographics within a large sample trial.
2 DR. ELLENBERG: I'm not sure I --
3 MS. TAYLOR: A large, simple --
4 DR. ELLENBERG: How are they analyzed?
5 MS. TAYLOR: No. In terms of the relevant
6 patient population section, your first section, where
7 the relevant patient population was defined as all
8 seropositives, my concern is about the inclusion of --
9 or the ethnic breakdown of, the inclusion of women,
10 the visibility of the inclusion of substance abusers
11 in a large, simple trial.
12 I mean, what is simple? Is it so simple
13 that all three of those are negated as factors in the
14 population?
15 CO-CHAIRMAN CARPENTER: Dr. Yusuf, do you
16 want to reply to that?
17 DR. YUSUF: As one of the people here
18 probably who has dabbled a little bit in the concept
19 of these trials, I think your concerns are important.
20 In fact, large, simple trials tend to also go with
21 what's called the uncertainty principle, which many of
22 you here heard of.
NEAL R. GROSS
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