Clinical Trial Analysis and Reporting Flashcards
What is a Statistical Analysis Plan?
A document containing more technical and detailed elaboration of the principal features of analysis described in protocol
Who is the SAP developed by?
Trial statistician
When is SAP made?
Basic SAP agreed before the trial starts, signed off before analysis starts
signed off by CI and lead statistician
Can be reviewed and agreed by IDMC/TSC
What are the guides to make an SAP?
Usually have templates and SOPs to guide it
Details to include in the SAP 5
- Level of statistical significance to use
- How to handle multicenter data, patient withdrawals…
- Methods for blinding statistician
- How to handle missing data…
- IT software detail…
ICH GCP guidelines with data analysis:
All trial info should be recorded, handled and stored in a way allowing accurate reporting, interpretation and verification
Also confidentiality of patients should be supported
What is intention to treat analysis?2
Includes every subject who was randomised according to their randomised treatment assignment
Ignores non compliance, protocol deviations, withdrawal…
Why is intention to treat good?
Avoids overoptimistic estimates of efficacy that happen by removing non compliers
If not intention to treat analysis, what analysis do you use?
Pre-protocol analysis
What is preprotocol analysis
Compare treatment groups according to what treatment they actually received and completed
What is EQUATOR?
Enhancing quality and transparency of health research
Aims to improve reliability and value of published health research lit
Has guidelines and tools
STROBE
Observational Studies
PRISMA
Systematic reviews and meta analysis
PRISMA-P
Protocol
CONSORT
CLinical trials
