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

183

1 you look at the realities of recruiting, first of all,
2 there's going to be a two-month delay in cultivating
3 B cell lines in these patients, which is an inclusion
4 criteria to determine their CTL responses, which is
5 one of the major things that we're interested in doing
6 in the trial.
7 Another real issue is that both the
8 proliferative responses and the CTL responses within
9 that trial and being done at multi-center sites who
10 have no established quality assurance between them at
11 this point, no standard protocol worked out, and no
12 one who is in charge of developing those standard
13 protocols. So, therefore, I think we've got some real
14 logistic issues with getting this trial off the ground
15 and data analyzed.
16 There's no methodology set up with SDEC
17 that is proven for transmitting the type of CTL and
18 proliferative data electronically, which is going to
19 delay data analysis.
20 So while there may be temptations to wait
21 on 209 and 214, I think we also have to understand
22 that there are going to be some logistic problems and
NEAL R. GROSS
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