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

33

1 Phase II trials use clinical events as primary end
2 points. Next slide, please.
3 Let's talk for a moment about measuring
4 therapeutic benefit in this area. This may be the
5 crux of our deliberations today. The generation of
6 immune responses is extremely intriguing,
7 scientifically interesting, potentially
8 pathogenetically relevant; but we must recognize that
9 it infers an unknown or has an unknown relation to
10 clinical outcome.
11 So even though we're observing immune
12 responses, at this time we cannot say what that means
13 in terms of ultimate clinical benefit.
14 With respect to CD4 stabilization, it's
15 clear that CD4 declines lead to susceptibility to
16 opportunistic infections. So changes in CD4 ought to,
17 just by almost common sense, be of potential benefit.
18 However, there is an unproven association between
19 therapy induced changes and clinical outcome, and in
20 the area of anti-retriviral therapy, the use of
21 surrogate markers, even to this day, is not highly --
22 therapy induced changes in surrogate markets is not
NEAL R. GROSS
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