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

172

1 that has clinical endpoints for their endpoints.
2 With DDI, less than 100 people had taken
3 the drug for less than a year, at which point the drug
4 was entered into Phase II trials, which enrolled over
5 2,600 people, and a parallel track people that
6 enrolled 23,000 patients.
7 I think what's important to point out here
8 is that here it's the community that is requesting
9 that those two operations, the Phase II and the
10 access, be synthesized into a large, randomized study,
11 that the perfect is truly the enemy of the good.
12 In response to Dr. Corey's concern about
13 the effect of a marvelous new drug on endpoints, I
14 wish there were marvelous new drugs bursting out over
15 the horizon every six months, but there aren't.
16 And if there are, we would change our
17 protocols to incorporate them. The way we did with
18 aerosolized pentamidine was allowed by the early AZT
19 trials done by the ACTG. You have to change the trial
20 when an effective new drug comes along. People on AZT
21 or placebo don't differentially start taking another
22 useful drug. They both add it to their regimen.
NEAL R. GROSS
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