01439nas a2200169   4500000000100000008004100001260001100042100001800053700001800071700001600089245007000105856005800175300001200233490000700245520100300252022001401255       2019                            d  c2019-41 aChi Heem Wong1 aKien Wei Siah1 aAndrew W Lo00aEstimation of clinical trial success rates and related parameters  uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6409418/  a273-2860 v203 aPrevious estimates of drug development success rates rely on relatively small samples from databases curated by the pharmaceutical industry and are subject to potential selection biases. Using a sample of 406 038 entries of clinical trial data for over 21 143 compounds from January 1, 2000 to October 31, 2015, we estimate aggregate clinical trial success rates and durations. We also compute disaggregated estimates across several trial features including disease type, clinical phase, industry or academic sponsor, biomarker presence, lead indication status, and time. In several cases, our results differ significantly in detail from widely cited statistics. For example, oncology has a 3.4% success rate in our sample vs. 5.1% in prior studies. However, after declining to 1.7% in 2012, this rate has improved to 2.5% and 8.3% in 2014 and 2015, respectively. In addition, trials that use biomarkers in patient-selection have higher overall success probabilities than trials without biomarkers.  a1465-4644