BreakOut Session Addendum to the October 2008 Antimicrobial ...

Antimicrobial workshop ­ Breakout session discussion
Page 8
When considering study designs for hemoparasite diseases, the difficulties in identifying
the appropriate clinical endpoints of success were discussed. Once veterinary experts
determine the appropriate outcomes of clinical success, then multiple centers might be
able to prospectively enroll cases. Additionally, the use of concurrent medications in
hemoparasite cases should be considered. All current studies allow for an escape clause
so non­responsive cases can be removed from the study for individual health reasons.
Such escape clauses would be necessary if there was a concurrent infection necessitating
additional therapies outside of the proscribed treatment protocol.
Conclusion
In summary of the round­table discussions, which were presented at the end of the
workshop to all the participants, multiple ideas were discussed that could possibly
facilitate the approval path for additional claims for antimicrobial drugs in companion
animals. However, no specific conclusions and agreements were reached during this
meeting; it just opened a door for further discussions between the CVM and drug
sponsors. Both parties welcome continued discussion.