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

190

1 If it's not working, it's too expensive,
2 shut it down or if one arm is working and the others
3 aren't, then you do what's best for the people in the
4 trial.
5 So all of these things are issues, and I
6 think we must carefully understand the issues, the
7 real ones and the potential ones, and try to
8 understand those up front. But I don't think they
9 should keep us from moving forward. There are ways to
10 deal with those issues.
11 DR. YUSUF: I think many of the issues
12 raised here are very relevant. Many of them are
13 relevant to trials in general, like liability. What
14 happens if you did a small trial? The same issue.
15 What if a new therapy came about? These are issues in
16 general relevant.
17 Again, the point that you raised, that if
18 you have an effective therapy, you shouldn't deny it
19 to the people in the control group or the people at
20 large, are general issues.
21 We have dealt with these issues in
22 previous trials using standard trial methodology. I
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