Clinical development · historical benchmarks
Estimate the probability of advancing your program.
Select a therapeutic area and a development milestone to see the success rate reported in Clinical Development Success Rates and Contributing Factors 2011–2020 (February 2021).
14 therapeutic areas, an “Others” group, and an all-indications benchmark from Figure 2.
Choose a therapeutic area first. In this report, Phase 3 success means advancement to NDA/BLA filing; filing after a separately successful Phase 3 trial is not measured.
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3. Probability of success
Select both fields, then choose Calculate estimate.
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How to interpret the estimates
The source divides advanced programs by advanced plus suspended programs. The displayed n counts transitions, not patients or individual trials. Ongoing programs without a recorded transition are not included in that denominator. Suspension can reflect business decisions as well as clinical or regulatory outcomes.
The data cover company-sponsored, FDA registration-enabling development from January 1, 2011 to November 30, 2020. Regulatory success is eventual FDA approval after NDA/BLA submission, including resubmissions—not first-cycle approval. An observed 100% does not guarantee future success.
Phase 3 success uses the report’s Phase 3-to-NDA/BLA definition. The report does not provide a separate probability of meeting a Phase 3 trial endpoint, or of filing conditional on already having a successful trial. Those are different questions.
When shown, the approximate chance of eventual approval from the selected starting phase multiplies the remaining published transition rates. It uses rounded inputs, may differ slightly from the report’s likelihood-of-approval figures, and is not an independent patient or program cohort estimate. No additional Phase 3 probability is multiplied in.
Gastroenterology excludes inflammatory bowel disease. “Others” groups dermatology, renal, obstetrics, non-autoimmune rheumatology, ENT/dental and orthopedics. These groups are not separately estimated here.
Data note: Figure 2 (page 7) and Figure 4 (page 9) report Oncology Phase 3 success as 47.7%; the page 8 narrative says 47.5%. This calculator consistently uses Figure 2’s 47.7%.
Source and methodology
BIO, Informa Pharma Intelligence and QLS Advisors. Clinical Development Success Rates and Contributing Factors 2011–2020, February 2021. Figure 2, page 7: therapeutic-area rates and sample sizes. Pages 6 and 9: stage definitions and regulatory outcomes. Page 30: calculation methods. Source databases: Biomedtracker and Pharmapremia.
Fixed report-based dataset; no live database connection. The calculator uses published aggregate statistics, not the underlying proprietary records. Estimates are based on historical program-level benchmarks (not on a successful primary efficacy endpoint).