Docket Management
Docket: 01D-0489 - Draft Guidance: Clinical Trial Sponsors on the Establishment & Operation of Clinical Trial DMCs
Comment Number: EC -6

Accepted - Volume 1

Comment Record
Commentor Dr. Corsee Sanders Date/Time 2002-01-28 19:24:45
Organization Genentech, Inc.
Category Company

Comments for FDA General
1. General Comments 1. The guidance implies that the study is blinded. It should be more specific and state that the independence of the DMC is more relevant to blinded trials. 2. For large 'sponsor organizations', the infrastructure is such that there can be a group within the organization but independent of the clinical team and the staff responsible for decisions regarding the project. In this case, the guidance may be targeted to the project team rather than the entire sponsor organization. 3. The DMC should review unblinded data. This should be emphasized more.

EC -6