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

147

1 are being developed at this point that are very
2 interesting ELISA tests that are going to be
3 relatively inexpensive that I also think that need to
4 be verified in large trials like this in comparison to
5 standard CD4 tests and also could be done cheaply and
6 make the large simple trials more interesting because
7 we can get CD4 data at a lot of sites inexpensively.
8 I think that's important.
9 I think that in the various strata that
10 you've listed, I think in your lower two strata, the
11 clinical endpoint as an endpoint is a very reasonable
12 way to go. I think in the higher strata, we're going
13 to have to have at least a significant subset.
14 This is going to be driven in my mind
15 purely by cost because I think we should take as much
16 CD4 data, at least CD4 data, as we can in that higher
17 subset because I believe that if we're going to
18 determine the efficacy of these products when people
19 at lower T cells have clinical benefit if, indeed,
20 they do, I think the approval of these agents that
21 will make them available to people will be one
22 relatively small CD4 changes.
NEAL R. GROSS
COURT REPORTERS AND TRANSCRIBERS
1323 RHODE ISLAND AVENUE, N.W.
[phone] WASHINGTON, D.C. 20005 [phone]