[andreyf]

Sorry for not expounding, that was indeed a bit opaque. I don't have first hand experience with the industry and so would appreciate any corrections to my understanding of it.

When research is done via contract between two companies, it can be more effectively regulated to prevent hiding or discarding of results. I imagine there are already laws in place saying a company can't hide research results like this and CROs make compliance more likely because they do not benefit from hiding bad results as pharmaceutical manufacturers do. I don't think publication rights are the important bit here, but compliance with rules about disclosure to the FDA.

[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!