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

195

1 have this problem. Pertussis is a beautiful example
2 of where we don't have a good surrogate. And we have
3 struggled with this. I don't know that the CD4 count
4 is the best surrogate, but it certainly is an
5 indicator.
6 Are there other surrogates that we can
7 think of, potential surrogates? Certainly in any
8 trial where you don't have good surrogates, part of
9 the trial should be attempting to identify surrogates
10 because this is not going to be the only vaccine
11 tested, presumably. And if you can develop
12 surrogates, that speeds up the whole process.
13 I personally see good reason to proceed
14 provided we can set up a protocol that will give us
15 the answer. The worst thing we could do would be to
16 set up in a hurry some trial that won't give us the
17 answer.
18 Now, I suspect that we can do it, but
19 there are a lot of issues that have to be struggled
20 with in the process, which range all the way from the
21 things that Ted Cooper brought up to more social and
22 other issues, even ethical issues.
NEAL R. GROSS
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