Oncology Drugs Approved the Fastest According to Largest Study on Clinical Development Success Rate
Wednesday, May 25, 2016
Amplion, Biomedtracker and the Biotechnology Innovation Organization (BIO) have partnered to conduct the largest ever study of clinical development success rates.
The study recorded and analyzed 9,985 clinical and regulatory phase transitions, across 1,103 companies. Using clinical trial data from the past decade, “Clinical Development Success Rates 2006-2015” compares groups of diseases, drug modalities and other attributes to generate the most comprehensive analysis, to date, of biopharmaceutical R&D success.
“This study provides a wealth of information about drug development success rates across a broad range of indications,” said Cartier Esham, PhD, BIO’s Executive Vice President, Emerging Companies. “The results may be used to pinpoint disease areas and phases of development where the industry has been most successful in recent years, as well as areas presenting challenges along the capital intensive-pathway of drug development.”
Key findings from the study include; Clinical trial programs that used selection biomarkers saw an overall likelihood of approval (LOA) from Phase I of 25.9%, compared to 8.4% when no selection biomarkers were used. The overall LOA from Phase I for all developmental candidates was 9.6%, and 11.9% for all indications outside of Oncology. Of the 14 major disease areas studied, Hematology had the highest LOA from Phase I (26.1%) and Oncology had the lowest (5.1%). Oncology drugs were approved the fastest of all 14 disease areas. Rare disease programs 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.
“Combining Amplion’s biomarker database with Biomedtracker’s clinical transition records we were able to, for the first time, quantify the benefit of using selection biomarkers in drug development,” said study author David Thomas, CFA, BIO’s Senior Director of Industry Research. “In combination with the rare disease section of the report, these results appear to be revealing the overall strength in targeting well-defined, homogenous patient populations.”