This draft guideline deals with the methodological considerations fusing progression free survival (PFS) disease-free survival (DFS) in confirmatory trials.

The use of PFS and DFS as endpoint in clinical efficacy trials present several methodological issues that need to be addressed. This draft guidance hopes to provide some regulatory guidance on these issues specifically referring to definitions, frequency and methods of assessment ascertainment bias handling of deviations and missing data and finally radiological review.

The guidance goes into details of defining the clinical endpoints and how they should be implemented. More details can be found in the embedded draft document below.