Phase 4: Analysis & publication
Goal:
- Analyse data according to the primary and secondary endpoints
- Publish the results
Statistical analysis
- Obtain (cleaned) data through CDM and other parties
- Have data analyzed by the trial statistician according to the SAP
- Interpret and discuss outcomes with the trial statistician
- Define answers to primary and seconary endpoints
- Determine message/conclusion of results
Reports
- Prepare a final report within a year after the trial has closed
- Prepare a lay summary, preferably with patient advocates
- Report to funding partners
Manuscript preparation & publication
- Decide how & where to publish results
- Check agreements with funding partners prior to publication of results
- Involve patient advocates in interpretation & formulation of results
- Write a layman’s summary and upload in CTIS
- Prepare manuscript according to instructions of publisher
- Have manuscript reviewed by co-authors & funding partners
- Submit manuscript
- Respond to review comments
- Publicly disclose results in a clinical trial registry
- Update information on Onderzoekbijkanker.nl
- Inform patient organizations about results