Data manipulation [GxP / QC / QA]

posted by Ohlbe – France, 2023-07-22 22:47 (357 d 05:46 ago) – Posting: # 23683
Views: 7,461

Dear Mittyri,

❝ Could you please elaborate how is it possible?

❝ What is the method CRO used for duplication? just copy all concentration points to another subject? what about chromatograms? Did they fake date/time of that?


No. Simply re-analyse samples of subjects already analysed, under a different subject number. Your T/R is too high ? You want to bring it lower ? Select one previous subject with known expected concentrations, or periods from different subjects (let's say 10 and 14), write everywhere these were the samples of subject 45, and you're done. The first description I have seen of this was made in an inspection report, which somebody obtained under a freedom of information regulation and posted on internet. See document A3 - ANSM Preliminary Report. See also FDA's letter to Semler Research, a few years later.

❝ Why experts didn't find it before? Are the methods of data manipulation recognition just implemented?


Well, that French report from 10 years ago already described the general principle. A well-known usual suspect made a detailed publication describing tools and methods.

The problem is not just detecting data manipulation. The problem is collecting enough evidence. If you find signs of data manipulation in one study, you can reject that study. Triggering an article 31 referral to reject all studies from a given CRO probably requires a solid level of evidence. Not just to convince the CHMP: to convince lawyers.

Regards
Ohlbe

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