Clinical Development Success Rates Study


Screen_Shot_2016-05-23_at_10.52.42_AM.pngBioMedTracker, 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.