Clinical trial success rate & failure risk calculator
Score any Phase 1, 2, or 3 design against the published BIO/Informa phase-transition benchmarks in under five seconds. See your probability of success, your likelihood of approval, and the exact design decisions costing you the trial.
Your trial design
Risk drivers
- Oncology base rateodds ×0.70
This therapeutic area transitions below the all-indication average.
- No prior human efficacy for this mechanismodds ×0.85
First-in-mechanism programs carry the biology risk into the pivotal read.
- Analyzable N is 85% of the powered requirementodds ×1.00
Slight shortfall against the powered N after attrition. Inflate enrollment to protect the analysis.
Clinical trial success rate questions
- What are clinical trial success rates by phase?
- Across 12,728 development programs (BIO/Informa/QLS, 2011–2020), Phase 1 to Phase 2 transition succeeds about 52% of the time, Phase 2 to Phase 3 about 28.7%, and Phase 3 to filing about 57.8%. Overall likelihood of approval from Phase 1 is roughly 7.9%.
- How does this calculator estimate my trial's probability of success?
- It starts from the published phase-transition rate for your phase and therapeutic area, then applies transparent odds multipliers for effective power after dropout, endpoint multiplicity, SAP lock, biomarker enrichment, prior human efficacy, endpoint type, and site count. Every multiplier is displayed with the result — nothing is hidden in a black box.
- Why do most clinical trials fail?
- The two dominant causes are lack of efficacy and underpowering. A study that enrolls to its powered N but loses 20% to dropout is analyzing roughly 80% of the required sample, which can turn a real effect into a negative trial. Uncontrolled multiplicity across endpoints is the third recurring failure.
- Is this a regulatory-grade prediction?
- No. This is a free screening estimate built on public industry base rates and is research use only. It is not medical, statistical, or regulatory advice, and it does not replace a biostatistician or a formal power calculation.
Research use only. Base rates are from the BIO / Informa Pharma Intelligence / QLS analysis of 12,728 development programs (2011–2020). Modifiers are transparent odds multipliers, not a validated predictive model. This tool is not medical, statistical, or regulatory advice and does not replace a formal power calculation or a qualified biostatistician.
What Quandra v8 adds
These calculators give you one number at a time. Quandra v8 writes the statistical analysis plan, generates R/SAS code, cross-checks assumptions against a locked reference corpus, and keeps an audit trail for regulated work.