Recombinant DNA Advisory Committee - 7/31/90 
undertaken with a different mind set. 
Dr. Anderson said that Dr. R. Murray pointed out to the 
subcommittee, that when it initially started, it had to cancel 
meetings because there were no protocols. In fact the members 
undertook a "practice protocol" in order to learn about 
protocols. Through this process the subcommittee has learned 
much about dealing with protocols and assessing them, whereas 
local review groups are still naive about this process. 
Dr. Epstein said he was worried this was a luxury that could not 
be afforded. He noted that Dr. Rosenberg was worried that the 
subcommittee could not handle the volume of protocols that will 
be forthcoming. Now the issue is being considered to give 
advisory opinions to people who do not have finished protocols. 
He said he felt it was an issue of how the subcommittee and the 
RAC was going to conduct its business. He felt if a protocol is 
submitted, it should be reviewed as a protocol, which is a lot of 
work. He said that what has happened in the past has happened, 
but that people must be informed that they cannot tie up the 
subcommittee reviewing preliminary protocols which are 
essentially unfinished. 
Dr. Anderson said he felt that in a couple of years this would 
indeed be impossible, but that in the initial stages it would be 
worthwhile to make efforts to educate the institutions. Dr. 
Epstein said he did not know how people could be expected to 
properly review a protocol that was not developed to the point 
where a review would be in order. 
Dr. McGarrity said that possibly other forums could be used to 
try to get the education process started. He suggested 
professional meetings, symposia, and the use of the Human Gene 
Therapy Journal as possible means of doing this. 
Dr. Miller said that FDA reviewers often meet with investigators 
long before they submit a proposal for a clinical trial and 
discuss three general areas: the physical-chemical 
characterization of the product, the supporting animal studies 
that need to be done, and the clinical protocol and time lines 
for these. This is important, especially for academic 
investigators, in preparing formal proposals. Further, he added 
that the RAC and the HGTS had been spoiled by the high quality of 
the applications from Drs. Anderson, Blaese, and Rosenberg and 
that such applications would be in the top tenth of one percent 
in quality, responsiveness, and comprehensiveness that he has 
seen. An average academic investigator could not be expected to 
be in that league as far as submitting a proposal, and yet he or 
she deserves the consultation and support to get to a stage where 
a protocol would have a chance for approval. 
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Recombinant DNA Research, Volume 14 
