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

123

1 So I think we should be realistically
2 about the fact that we're really simply not going to
3 f settle total aspects of safety.
4 CO-CHAIRMAN CARPENTER: We can't be
5 totally safe.
6 MR. HARRINGTON: I would like to take this
7 opportunity to introduce into the discussion a
8 consensus statement that's been developed by 12 AIDS
9 activist organizations from around the country that
10 recommends that this panel consider very seriously as
11 the proper outcome of its mission the generation of a
12 large randomized comparative trial in which entry
13 criteria are broad, data collection is simplified in
14 order to establish by virtue of a vast sample size
15 whether gp 160 or, for that matter, any other
16 appropriate vaccine candidate provides clinical
17 benefits to people with HIV disease.
18 I would like to ask if NIH or anyone else
19 has prepared any statistical work that might show us
20 what size of a study would be needed in order to, say,
21 compare three vaccine products against a placebo in
22 HIV-positive people at various T cell levels.
NEAL R. GROSS
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