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

191

1 mean, there's a long history of how to do it. So, if
2 you'll trust me, let me just say that this is
3 something that's been looked at in every trial.
4 The liability issue is the most difficult
5 of all of these because I believe many years ago this
6 was looked into, and the insurance company charges you
7 more than the trial actually costs to cover liability.
8 I believe most NIH trials don't have any liability
9 coverage so far.
10 The one point you raised, Dr. Cooper, is
11 absolutely relevant, the production of the drugs. I
12 don't think you can wait until the last minute to
13 choose the drug because I know if large trials, the
14 ISIS III trial, have had to deliberately slow down
15 because we didn't have enough drugs. That is
16 something you want to deal with as early as possible.
17 CO-CHAIRMAN CARPENTER: Dr. Burke?
18 DR. BURKE: Yes. I'm Don Burke. I'm the
19 Director of AIDS Research at Walter Reed.
20 In our own deliberations in the Army, we
21 have been trying to ask a series of questions to help
22 us make these decisions about whether to go forward
NEAL R. GROSS
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