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Jan 9, 2017

Clinical Development Success Rates 2006-2015..

News by: Burak Kıran - Sanofi

Key takeaways: 

  • The overall likelihood of approval (LOA) from Phase I for all developmental candidates was 9.6%, and 11.9% for all indications outside of Oncology.
  • Rare disease programs and programs that utilized selection biomarkers had higher success rates at each phase of development vs. the overall dataset.
  • Chronic diseases with high populations had lower LOA from Phase I vs. the overall dataset.
  • Of the 14 major disease areas, Hematology had the highest LOA from Phase I (26.1%) and Oncology had the
    lowest (5.1%).
  • Sub-indication analysis within Oncology revealed hematological cancers had 2x higher LOA from Phase I than solid tumors.
  • Oncology drugs had a 2x higher rate of rst cycle approval than Psychiatric drugs, which had the lowest percent of rst-cycle review approvals. Oncology drugs were also approved the fastest of all 14 disease areas.
  • Phase II clinical programs continue to experience the lowest success rate of the four development phases, with only 30.7% of developmental candidates advancing to Phase III. 
Click here for the full report

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