Traditional development path
Alternative approaches
(PHASE 2, PHASE 2/3 adaptive, skip to PHASE 3)
Alternative development approaches
back to traditional development path
Decision on trial design
(PHASE 2, PHASE 2/3 adaptive, skip to PHASE 3)
Requirements to skip phase 2
PHASE 1
PHASE 1 preparation
Microbiology
Non-clinical safety
PK/PD
PHASE 1 trial setup
Protocol development
CRO selection
PHASE 1 execution
PHASE 1 analysis
End-of-PHASE 1 meeting
PIP application (EMA)
PHASE 2
PHASE 2 preparation
Microbiology
PK/PD
PHASE 2 trial setup
Protocol development
CRO/central lab selection
PHASE 2 execution
Phase 1 studies to be conducted in parallel with PHASE 2
PHASE 2 analysis
End-of-PHASE 2 meeting
iPSP submissions (FDA)
PHASE 2/3adaptive design
PHASE 2/3 preparation
Microbiology
PK/PD
PHASE 2/3 trial setup
Protocol development
CRO/central lab selection
Definition of decision rules
PHASE 2/3 execution
Predetermined interim analysis
PHASE 2/3 analysis
iPSP submissions (FDA)
Submissions (e.g. NDA, MAA)
PHASE 3
PHASE 3 preparation
Microbiology
PK/PD
PHASE 3 trial setup
Trial design
Protocol development
CRO/central lab selection
Definition of decision rules
PHASE 3 execution
Completion of studies
Break development
Initiation of surveillance
Work with AST manufacturers
PHASE 3 analysis
Submissions (e.g. NDA, MAA)