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

143

1 more data on the surrogate endpoints. I think there
2 is a need to validate our surrogate endpoints because
3 it's unimaginable that every vaccine is going to be
4 tested by large, simple trials.
5 So this may be an opportunity to find out
6 how the surrogate endpoint changes relate to the
7 outcome. And in the two different kinds of vaccines,
8 if we find significant changes on surrogate endpoints
9 and on outcomes, then you know the surrogate means
10 something. So I wouldn't throw that out.
11 A third issue I'd like to add to this is
12 in some of these documents, somewhere it said in the
13 deliberations of the vaccine group, that unless
14 somebody was likely to give you a 60 percent response,
15 it wasn't worth testing. Now, that may be true in an
16 ideal world, but I think even a 25 percent response is
17 enormously worthwhile in a common disease like this.
18 The other thing I'd like to say is if
19 there are two agents that each give you 25 percent,
20 but act by different means, they could be additive,
21 like in the ISIS II trial, where simple aspirin double
22 the benefits of thrombolytic therapy. So each gave
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