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

175

1 with a large trial, the chance that we're going to
2 have an imbalance if we really have a blinded study is
3 really very small.
4 DR. BRODER: I'm in favor of a large
5 trial. I think we should move quickly, but I think we
6 have to make sure that issues such as access or
7 whether everybody is going to have the same level of
8 technology applied to them, we've gone through that.
9 I mean, we know what happens when you
10 don't have access to the most modern thing. When a
11 population doesn't have access, the odds are that that
12 population won't do as well as another group.
13 So I'm saying that that be incorporated in
14 the plan up front. It's not introducing a delay.
15 DR. ELLENBERG: Sure.
16 DR. BRODER: It's just recognizing a
17 reality.
18 DR. YUSUF: If I may make a brief comment?
19 I think there may be a misunderstanding of what a
20 large, simple trial is. Simple doesn't mean no data
21 collection. It's a collection of key and focused
22 data. So you have a group of people who say exactly
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