PIPEDREAM: Pharmaceutical Innovation, Progression Errors, Development Risks, Efficiency and Attrition in Medicine

The PIPEDREAM model estimates false positive and false negative rates for each phase of the drug development process using data on attrition and marketing rates for each phase of development. We illustrate the model using aggregated historical data for the pharmaceutical industry from 1997-2007. These data suggest that false positive rates were high, and false negative rates low, throughout the early phases of development during this period. False positive rates were lowest and false negative rates peaked during Phase 2 clinical development. Furthermore, there was evidence of progression-seeking behaviour in Phase 3, with more molecules progressing to submission than might be expected.