![]() Even when looking only at lead indications, still about 30% of drugs in Phase 3 fail to reach approval. This means that around 2 out of every 5 drugs that reach Phase 3 “confirmatory” trials still fail to win approval for the indication being investigated. ![]() Interestingly, the POS to get from Phase 3 to approval was only 59.0%. Not surprisingly, the highest POS was for drugs moving from Phase 1 to Phase 2 (66.4%), while the lowest POS was for drugs moving from Phase 2 to Phase 3 (58.3%). This number was slightly higher than other recent analyses of similar data sets ( Thomas 20). Based upon their analysis, the overall probability of success (POS) for industry-sponsored drugs entering Phase 1 trials to obtain FDA approval was 13.8%. Their findings were published in Biostatistics. Data sources included, press releases, and analyst reports, along with a number of other primary and secondary sources. Their database of clinical trial information and drug approval data spanned over 15 years (2000 – 2015) and included over 400,000 separate data points representing over 21,000 compounds. One of the most recent assessments was performed by researchers at the MIT Sloan School of Management led by Charles E. But why? Clinical Trial Success RatesĪs a first step, let’s get a sense of how successful drug developers are with clinical trials by taking a look at some estimates of clinical trial success rates. Yet, despite all of these investments, clinical trials don’t always succeed. Large quantities of time, money, and intellectual capital are expended to plan and execute clinical trials. DMPK and Translational Discovery and Development.Pharmacometrics (PMx), Pharmacokinetics, Pharmacodynamics (PK/PD).Model Informed Dose & Drug Development (MIDD).Clinical Pharmacology Integrated Drug Development.Clinical Pharmacology Modeling Simulation.Biostatistics and Statistical Programming.Chemistry, Manufacturing, and Controls (CMC).Regulatory and Drug Development Consulting.
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