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

154

1 go from the information we have to even a large,
2 simple trial I'm going to say to you that I'm a bit
3 concerned about aside from the scientific issues.
4 Much of what we've done; for example, when
5 we had the parallel track or expanded access for DDI,
6 the representation of populations in that was still
7 rather narrow and even though that was widened access.
8 How are we going to feel comfortable that
9 large, simple trial actually means that you're
10 actually going to get enough of a heterogeneity of
11 population to be able to make something out of that?
12 Aside from the logistical problems of
13 setting up such a system, -- and I think that will be
14 still quite large, and I don't think we should
15 underestimate that -- if we try to do a large, simple
16 trial with 10,000 individuals, that's going to take
17 one heck of a network in terms of having
18 heterogeneity.
19 If you, in fact, are focusing on 10,000
20 individuals who already have access to a health care
21 system, then you have a different type of patient
22 population and demography.
NEAL R. GROSS
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