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

.25
1 especially if the feeling is you have to wait for
2 these results?
3 Is it possible that the studies could be
4 started sooner, done in more centers, completed more
5 rapidly so that as this bigger trial is being planned,
6 these data will be available more rapidly?
7 DR. WARA: The question is: Can we speed
8 up the process? These studies were first planned.
9 The planning process began about three months ago.
10 One of them is to go to the Food and Drug
11 Administration this week. I think that's fairly
12 rapid. The second will go within a month. The
13 perinatal trials are proceeding very rapidly as well.
14 We feel it will take only about six months to accrue.
15 Now, the problem with doing any of the
16 studies and all of them, the problem with doing them
17 at enormous numbers of sites when you look at the
18 number of infants that we're going to enroll is that
19 the infrastructure and the planning to get them up and
20 rolling is going to take as much time as the accrual
21 of patients, if that makes sense.
22 I think to accrue -- it doesn't?

NEAL R. GROSS
COURT REPORTERS AND TRANSCRISERS
1323 RHODE ISLAND AVENUE, N.W.
[phone] WASHINGTON, D.C. 20005 [phone]