Hear author David Thomas discussing the report on June 6 at the 2016 BIO International Convention during his session, "The State of the Innovation Industry." Please also visit Biomedtracker and the rest of Informa Pharma Intelligence at Booth #505 (South & North Halls).

Biomedtracker, Amplion, and BIO are releasing 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.

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.