DSMB & adaptive analysis
Pre-specified interim analyses executed to support Data Safety Monitoring Board review and adaptive design decision points.
What's included
What goes into the interim analysis
- Interim analysis executed strictly against the pre-specified interim SAP and boundaries
- Unblinded programming and analysis performed by statisticians firewalled from the operational study team
- Results packaged into the report format the DMC/DSMB charter requires
- Access controls and distribution limited to the independent committee, not the sponsor study team
- Findings reconciled against stopping rules and boundaries defined in the DMC charter
Integrity controls
Independent, firewalled unblinded analysis teams that protect study blinding while still working from the same ADaM datasets used for final analysis.