la biblia del dichoso comite, hala! Pa'l que tenga ganas de leer :)
http://www.fda.gov/RegulatoryInformation/Guidances/ucm127069.htm
Interesante, 4.2.
4.2.1. Interim Data
... Interim comparative data, whether treatment assignment is revealed or coded, will be most securely protected from inadvertent or inappropriate access by the sponsor or its project team if the data are prepared for analysis by a statistical group that is independent of the sponsor and investigators—that is, the group is not otherwise involved in the trial design or conduct and has no financial or other important connections to the sponsor or other trial organizers ...
4.2.2. Interim Reports to the DMC
...We recommend that any part of the interim report to the DMC that includes comparative effectiveness and safety data presented by study group, whether coded or completely unblinded, be available only to DMC members during the course of the trial, including any follow-up period—that is, until the trial is completed and the blind is broken for the sponsor and investigators....
Sponsor es GALE.
Creo que queda claro que GALE ni huele los datos.