The Biotechnology Innovation Organization (BIO) released a study of 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, Ph.D., 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:
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.”