Plan your Phase 2 program from proof of concept to the Phase 3 decision
Work through 7 stages, from the end-of-Phase-1 data review to the End-of-Phase-2 meeting with FDA.
Open any step to see its typical duration, key deliverables and sub-steps.
Stage 1: Phase 2 Strategy and End-of-Phase-1 Review
Review the Phase 1 data, set the dose range and decision criteria, and choose between separate 2a and 2b studies or a combined design.
Stage 2: Protocol and Statistical Design
Write the protocol, choose endpoints and biomarkers, design randomization and blinding, and pre-specify the statistical analysis.
Stage 3: Regulatory and Ethics Submissions
Add the Phase 2 protocol to the IND, get FDA input where the design needs it, and secure IRB or ethics committee approval.
Stage 4: Study Startup and Site Activation
Select the CRO and vendors, find sites with access to the patient population, set up safety oversight and drug supply, and activate sites.
Stage 5: Enrollment, Treatment and Safety Oversight
Enroll patients, run the treatment and follow-up periods, monitor sites, report safety events, and support DSMB reviews and interim analyses.
Stage 6: Database Lock, Topline Results and Study Report
Clean and lock the database, unblind, run the pre-specified analyses, and write the clinical study report.
Stage 7: End-of-Phase-2 Meeting and Phase 3 Decision
Decide whether to proceed, propose a Phase 3 design, and agree the plan with FDA at the End-of-Phase-2 meeting.
The durations show typical ranges. Your timeline depends on the indication, the study design, the enrollment rate and regulatory feedback. Use this plan to orient your team, and take regulatory advice for your own program.
Keep your Phase 2 program on schedule from protocol to the End-of-Phase-2 meeting
Cambrian Life Sciences tells your team what to do next, drafts and tracks the work, and shows how each decision affects timeline, cash and enrollment before you make it.
Still preparing an IND? Score your program against 21 CFR 312 with the free IND readiness assessment.