The DSMB (Data Safety and Monitoring Board
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- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
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biopearl123
- Posts: 1669
- Joined: Fri Jul 20, 2018 5:13 pm
The DSMB (Data Safety and Monitoring Board
The DSMB has the power to stop the study for futility. At their first meeting, about one year from enrollment of the first patient, (approximately 50% enrollment) they did not.
Re: The DSMB (Data Safety and Monitoring Board
Any idea of when the next few DSMB's are expected?
On the note regarding the varying/diverging EU EMEA and US FDA standards, an interesting situation emerges (at least for a newbie like me).
If the study meets the EU endpoints, and is stopped - HOWEVER, US FDA end criteria are not yet met - does that imply that there is a incentive/need to simply continue with the study...at the expense of a delayed therapeutic?
thoughts from others on the board who know this better?
On the note regarding the varying/diverging EU EMEA and US FDA standards, an interesting situation emerges (at least for a newbie like me).
If the study meets the EU endpoints, and is stopped - HOWEVER, US FDA end criteria are not yet met - does that imply that there is a incentive/need to simply continue with the study...at the expense of a delayed therapeutic?
thoughts from others on the board who know this better?
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biopearl123
- Posts: 1669
- Joined: Fri Jul 20, 2018 5:13 pm
Re: The DSMB (Data Safety and Monitoring Board
Ashah, I do not know the answer to your question but suspect the FDA and EMA work in concert. It might be a good one to pose to Dr. Scarlett but this is a very small study for a PIII and I think they were looking for quick (full) enrollment and a relatively short read out time which of course has now changed. bp