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

1 7

1 Susan. It stems from what Larry said.
2 If, for example, we're one year into the
3 trial and we are accruing people very rapidly and, all
4 of a sudden, we have a few clinical trials come up
5 with protease inhibitors with tat inhibitors, et
6 cetera, from a statistical standpoint, can we assure
7 that there won't be skewing towards one versus the
8 other, one group in the trial, so that it will look
9 like Product X is really working when it's really a
10 result of the fact that many people on Product X are
11 also receiving a protease inhibitor?
12 So from a statistical standpoint, I
13 believe that's the point Sam is asking.
14 DR. BRODER: And also the fact that it may
15 be that some populations don't have access or cannot
16 afford certain medications. That will lead to a
17 certain skewing of the data.
18 DR. YUSUF: It may or it may not. It
19 depends.
20 DR. BRODER: I understand. But we can't
21 take the chance. We have to --
22 DR. YUSUF: Absolutely. I agree with you,
NEAL R. GROSS
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