[acveilleux]

That's not how CROs work usually work. Effectively, as far as the FDA is concerned, the CRO does not exist as a distinct entity, it's an organic part of the sponsor (i.e.: the reporting pharma.)

The sole organization reporting to the FDA is the trial sponsor.

A CRO that felt like it could just tip off the FDA could soon find itself without further contracts.

In addition, in a properly blinded trial, most of the players (whether CRO, sponsor or site/treating physician) have no clue who's being treated or not. Nor do they know much more than they need to conduct their business.

The safety of a clinical trial is normally the job of a data monitoring committee or something similar. They are normally independent and empowered to monitor the result and, most importantly, unblinded so they can actually use stats taking treatment into account to spot actual anomalies. They report to and are paid for by the sponsor. The sponsor is legally required to act on the findings and adverse events are required to be reported to the FDA. At least that's the theory.

Gory details here: http://www.fda.gov/downloads/RegulatoryInformation/Guidances...

[andreyf]

Got it. Thank you for the thorough explanation!