Abstract
The largest study yet assessing the success rates of clinical trials for drugs has yielded more optimistic data than previous studies. Andrew W. Lo and colleagues at the MIT Laboratory for Financial Engineering used an automated algorithm to draw data from nearly 186,000 unique trials of over 21,000 compounds, from January 2000 through October 2015. The team found that 13.8% of trials make it from Phase I to approval, a higher figure than the often-touted estimates of 10% (Biostatistics 2018, DOI: 10.1093/biostatistics/kxx069). The figure is even higher—20.9%—if cancer trials are excluded because cancer drugs had the lowest success rate, a mere 3.4%. Cancer trials that used biomarkers had higher success rates, though, and the overall oncology drug approval rate for 2015 was 8.3%. Vaccines for infectious disease and ophthalmology drugs had the highest success rates, with 33.4% and 32.6% of Phase I compounds, respectively, eventually approved. “It is encouraging to
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