Clinical Development Success Rates Study
BioMedTracker, Amplion, and BIO have released the largest study ever on clinical development success rates. This report examines success rates across ~10,000 clinical program transitions by therapeutic area as well as three unique categories: rare diseases, chronic high prevalence diseases, and programs utilizing selection biomarkers. The results show dramatic differences between disease groups and modalities.
Some Key Findings:
- Programs that utilized selection biomarkers had higher success rates at each phase of development vs. the overall dataset.
- Chronic diseases with high populations had a lower Likelihood of Approval (LOA) from Phase I vs. the overall dataset.
- Rare disease programs had higher a Likelihood of Approval (LOA) from Phase I vs. the overall dataset
- Hematology had the highest LOA from Phase I, and Oncology had the lowest.