Blind monitors or greedy sponsors? [GxP / QC / QA]
Dear Helmut,
Well, marketing authorisation holders / applicants were not necessarily the sponsor of the study. Some of them just bought the dossier off the shelf, before or after the marketing authorisation was granted. Due diligence: generally, nil, especially if the marketing authorisation was already granted. EMA organised a workshop with representatives of the generic drug industry some years ago, after the first referrals of this type. Nothing came out of it. Industry's position: "we can't audit the study when we buy the dossier coz' we were not the sponsor". It went nowhere.
Or just incompetent ? Or were some of the sponsors perfectly aware of the scam, and willing to use such CROs precisely because they were sure their study would pass ?
❝ also interesting the list of medicines concerned by the procedure. You can read it ‘backwards’, i.e., look at the sponsors.
Well, marketing authorisation holders / applicants were not necessarily the sponsor of the study. Some of them just bought the dossier off the shelf, before or after the marketing authorisation was granted. Due diligence: generally, nil, especially if the marketing authorisation was already granted. EMA organised a workshop with representatives of the generic drug industry some years ago, after the first referrals of this type. Nothing came out of it. Industry's position: "we can't audit the study when we buy the dossier coz' we were not the sponsor". It went nowhere.
❝ Given that, were monitors of the other sponsors or just greedy?
Or just incompetent ? Or were some of the sponsors perfectly aware of the scam, and willing to use such CROs precisely because they were sure their study would pass ?
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
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- Some more info Ohlbe 2021-09-17 20:28
- EU Article 31 referral started Ohlbe 2022-01-24 17:47
- Cheating Helmut 2021-09-17 16:50
- Increased variability Ohlbe 2021-09-17 17:56
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- Visualization Helmut 2021-09-18 15:26
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- Another two... jag009 2021-09-19 09:18
- Another two... ElMaestro 2022-05-24 12:00
- Blind monitors or greedy sponsors? Helmut 2022-05-24 12:51
- Blind monitors or greedy sponsors?Ohlbe 2022-05-24 14:21
- Blind monitors or greedy sponsors? Helmut 2022-05-24 16:35
- Blind monitors or greedy sponsors? ElMaestro 2022-05-25 08:11
- (Cumulative) T/R-ratio vs. time Helmut 2022-05-25 09:19
- Sponsors and CRO selection Ohlbe 2022-05-25 10:53
- I still think that T/R-ratios are useful Helmut 2022-05-25 12:04
- T/R-ratios are useful Ohlbe 2022-05-25 14:40
- T/R-ratios are useful Helmut 2022-05-25 15:35
- Bust the Buster Helmut 2022-05-26 15:32
- complicate the assessor's life mittyri 2022-05-26 18:28
- complicate the assessor's life PharmCat 2022-05-27 09:57
- complicate the assessor's life Helmut 2022-05-27 10:11
- Thanks for Busting the Buster sameep 2022-05-31 08:34
- Thanks for Busting the Buster Helmut 2022-05-31 15:22
- A small point for the code sameep 2022-06-01 13:17
- A small point for the code Helmut 2022-06-01 14:11
- A small point for the code sameep 2022-06-01 13:17
- Thanks for Busting the Buster Helmut 2022-05-31 15:22
- Thanks for Busting the Buster sameep 2022-05-31 08:34
- complicate the assessor's life mittyri 2022-05-26 18:28
- T/R-ratios are useful Ohlbe 2022-05-25 14:40
- I still think that T/R-ratios are useful Helmut 2022-05-25 12:04
- Sponsors and CRO selection Ohlbe 2022-05-25 10:53
- (Cumulative) T/R-ratio vs. time Helmut 2022-05-25 09:19
- Blind monitors or greedy sponsors?Ohlbe 2022-05-24 14:21
- Blind monitors or greedy sponsors? Helmut 2022-05-24 12:51
- Another two... ElMaestro 2021-09-17 08:42