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

141i
1 to separate until after a year or two on therapy.
2 So I think what we need to do is find some
3 kind of a middle ground. We don't want to have a
4 trial that's going to take a dozen years to give us an
5 answer, but perhaps to try and get an answer in as
6 short a time as two or three years might be
7 unrealistic as well.
8 CO-CHAIRMAN CARPENTER: Thank you very
9 much, Dr. Ellenberg. Those were some very, very
10 important considerations.
11 I wonder if Dr. Yusuf, who has had
12 experience with the ISIS trials you described, would
13 comment.
14 DR. YUSUF: Actually, large, simple trials
15 started off in vaccination. The very first large,
16 simple trial was a polio vaccine trial conducted in
17 this country about three or four decades ago. It
18 randomized 428,000 children within one year, got an
19 answer within one year. So that in the space of two
20 years, we had an answer.
21 Further, the actual vaccine used in that
22 trial was not the definitive vaccine. Later vaccines

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