Bioequivalence and Bioavailability Forum

Dear Ohlbe,

❝ When will people ever learn ?

As long as the risk of being caught is lower than the profit of conducting studies in cheap CROs – never. If shit* happens, the sponsor repeats the study in another CRO. The “guilty” CRO goes out of business and the staff move on to the next one, knowing now what to avoid and develop new methods of cheating.

❝ https://www.fda.gov/drugs/drug-safety-and-availability/fda-pharmaceutical-companies-certain-studies-conducted-raptim-research-pvt-ltd-are-unacceptable

THX for that one. Replicates across studies and – if I understand correctly – from different sponsors. This statement in the FDA’s letter is funny:

[…] in general, FDA would not expect study records to document the steps performed to generate falsified data; there­fore, a retrospective review must be complete and coupled with valid scientific explanations for the anomalous data.

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• I prefer that over the euphemistic “data integrity issues” or “lack of sponsor oversight“. It‘s plain fraught. Has anyone ever been sentenced to prison?