2005D-0310 Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
FDA Comment Number : EC1
Submitter : Dr. Christopher Baum Date & Time: 10/13/2005 11:10:23
Organization : Hannover Medical School
Category : Academia
Issue Areas/Comments
Hello, I have two comments on the recently published Guidancy for Industry:
1. Ref 10 of paragraph F isn't correct. Did you mean Li et al. (2002)-full citation given below?
2. F.1.c is somewhat problematic, because the method used to test for
clonality may itself bias the results. LM-PCR may sometimes generate a
false-positive, the same is true for an LAM-PCR whose sensitivity is
suboptimal because of insufficient validation by the investigator. As
different investigators use different methods and reagents, I would strongly
recommend that standards for clonality, oligoclonality and polyclonality are
being generated, similar as used for RCR and RCL studies.

Li Z, Dullmann J, Schiedlmeier B, M. Schmidt M, von Kalle C, Meyer J, Forster M, Stocking C, Ostertag W, Wahlers A, Frank O, Kuehlcke K, Eckert HG, Fehse B, Baum C. Murine leukemia induced by retroviral gene marking. Science 2002; 296:497