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Telecon Notes - Cervarix, December 14, 2007

STN 125259
Telecon Notes 
2:50 PM
GSK Participants:  Sharon Shapowal
FDA Participants:  Nancy Miller, Helen Sullivan


CBER contacted GSK regarding a question GSK had about unblinding of studies as a Complete Response letter is due to be sent to the sponsor regarding the Cervarix application.


Sharon Shapowal had asked Dr. Robin Levis in an earlier telecom this week a question about unblinding and CBER called to discuss this as CBER is preparing to send the CR letter. Ms. Shapowal asked if reading the letter might unblind the clinical team because of inclusion of PID numbers.  Dr. Miller responded that reading the letter may unblind the team because of inclusion of the PID numbers.  Ms. Shapowal asked if the PID numbers could be removed, but Dr. Miller did not feel that it was not possible to somehow redact this information.  Further, information we send in the letter may somehow unblind someone on the team.  CBER does not want to impact negatively the integrity of the ongoing studies, nor have blinded members to become unblinded at this time. CBER asked if GSK could have the letter go through their firewall team first or come up with some mechanism to prevent unblinding.  Ms. Shapowal indicated they would work on coming up with a method internally for dealing with this, and that the letter can be sent to her, and she will have it sent to the correct personnel so they can act on the letter as quickly as possible.


The telecom ended.