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

1 So a large, simple trial in order to be
2 representative, it doesn't mean that you only say
3 anyone can be involved who are interested in becoming
4 involved. You actually have to direct efforts to try
5 to recruit and accrue those populations.
6 DR. ELLENBERG: Right. That's very
7 important. And it says how we should do the trial.
8 I would agree with that.
9 CO-CHAIRMAN CARPENTER: Dr. Corey, I think
10 you have been waiting.
11 DR. COREY: Yes. I would reiterate the
12 point that Larry made about: In HIV, has there been
13 a large, simple trial? And also I would just like to
14 stress, having sat through these issues of the trials
15 for many, many years, that even though I personally am
16 an advocate of the vaccine approach going forward
17 very, very expeditiously, I am worried about the
18 conundrum that one is talking about -- and, Susan, I'd
19 like to get your thoughts on this -- in a vacuum as
20 if, especially in the less than 500, but even in the
21 greater than 500 group, the issues of trying to do
22 trials for extended periods of time, 2, 3, 4, or 5
NEAL R. GROSS
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