Length of Reporting Requirements
The proposed changes indicate that reporting
is required "until the trial is completed".
This term requires further definition. In
general, a completed trial is one closed
with the institutional IRB. Nevertheless,
some investigators have been asked to conduct
lifelong monitoring of patients for adverse
events. For example, lifelong monitoring
for replication competent retrovirus has
been required in a number of retroviral gene
transfer protocols. Clarification of "completed"
The Society also asks that OBA work with
the FDA to revisit the very onerous task
of lifelong monitoring. The Society believes
that issues such as the scientific basis
for lifelong reporting, patient compliance
and inconvenience, and investigator funding
and mobility have not been adequately addressed.
The Society is willing to bring its expertise
and experience to any discussions of this