BIO releases largest ever study on clinical development success rates

The study, conducted in partnership with Amplion and Biomedtracker, 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.

The study relied upon years of clinical program monitoring and data entry by Informa’s Biomedtracker service. BIO has long partnered with Biomedtracker to calculate success rates based on this data. More recently, BIO and Biomedtracker partnered with Amplion, the inventors of BiomarkerBase, to analyze the effects of biomarkers in clinical trial success.

"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."