Recombinant DNA Advisory Committee - 12/3-4/92 
from recombinants. The motion to approve the protocol passed by a vote of 16 in favor, 
0 opposed, and no abstentions. 
X. AMENDMENT TO THE POINTS TO CONSIDER REGARDING REPORTING 
REQUIREMENTS FOR HUMAN GENE TRANSFER/THERAPY PROTOCOLS 
Presentation-Dr. Leventhal 
Dr. Murray called on Dr. Leventhal to give a presentation on investigator's submitted 
progress reports. At the RAC meeting of September 14-15, 1992, the committee 
recommended that a letter should be forwarded to investigators of approved protocols 
regarding the progress of their studies. The letter suggested that the approval of their 
protocols might be reconsidered in the case of non-compliance. Essentially, responses 
were received from all investigators who have initiated their trials. 
Dr. Leventhal distributed a summary table of the information that was submitted by the 
responding investigators. The table included the following information: (1) 
investigator's name, (2) protocol title, (3) starting date, (4) target number of patients, (5) 
number of patients treated, (6) report of toxic effects, and (7) results. The results 
column described experiments that have demonstrated the transfer of the gene or 
demonstration of function resulting from the gene transfer. She provided a brief 
summary of the data that was submitted by the investigators in response to the letter. 
Dr. Leventhal stated that the RAC should develop a uniform data reporting format, 
similar to the one represented in the table. She requested input from other RAC 
members regarding the development of a proposed format. 
Dr. Parkman said that the proposed format is acceptable. However, the response 
column should include investigator responses in the same context that was originally 
proposed. In other words, if an investigator proposed three objectives for a protocol, 
he/she should submit responses according to how the data relates to each specific 
objective. For example, if gene marking of peripheral blood and tumor regression have 
been stated as goals, then the investigator should provide gene marking and tumor 
regression data. Dr. Leventhal stated that her only concern regarding data reporting on 
tumor regression is that the RAC should not usurp more of the investigator's information 
than they are required to present in a public forum. Dr. Parkman said that the 
investigators should be required to provide data that relates to the specific aims of the 
protocol. Dr. D. Miller suggested that the form should include a question that will allow 
the investigator to report any problems that were encountered in pursuing the protocol. 
Dr. Blaese stated that he had concerns about the request for detailed information 
because of the public forum in which the RAC meetings are held. One of the original 
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Recombinant DNA Research, Volume 16 
