In collaboration with colleagues in the Pharmaceutical industry, Berry Consultants has developed a powerful tool to help Biostatisticians to rapidly evaluate the value of the latter stages of a drug development program. This software tool is called QUOTES – “Quantification and Optimization of Trial Expectations Simulator” – the first tool for providing detailed estimates of the expected Net Present Value (eNPV) and Return on Investment (ROI) of a drug development program based on details of the proposed clinical development plan. There are very few tools to help plan the Phase II part of a drug development program. If the Phase II is large it increases cost, and delays the start of Phase III and hence the possible time of registration. If the Phase II is too small it will do too little to reduce the uncertainties of the treatment under development, and the wrong dose may be taken to Phase III, the wrong patient population tested in Phase III or the Phase III be too small or larger than necessary. Estimating how much a Phase II might lift the veil of uncertainty, and what value greater certainty could bring, is currently almost impossible.
QUOTES is a software system that helps clinical teams run simulations to make those estimates and hence optimize their clinical trial design choices in terms of the performance of the program as a whole. It does this very flexibly by allowing the user to supply the simulations of different proposed phase II trials (using FACTS for instance, but QUOTES is open ended and not constrained to using FACTS simulations). QUOTES then simulates the subsequent Phase III trials, (taking into account the estimate of effect size, the dose selection and the patient subgroups included at the end of each Phase II simulation) and assesses the time, cost and likelihood of success of each sequence of trials and then aggregates these over all the simulations. By comparing the estimates of value using different sizes of Phase II, different designs of Phase II, and different post Phase II go/no-go criteria, a clinical development team can make an impartial, unbiased, quantitative comparison of different strategies and choices.
The QUOTES simulation software is a fully supported, commercialized package that brings simulation of some of the most commonly used development program strategies straight to the statistician’s computer via a powerful user interface. The tool allows rapid evaluation of different development options that do not require complete re-simulation of the clinical trial.
QUOTES provides supports better clinical decision making, that can reduce risks, save millions of dollars and months of development time. For more information about QUOTES and/or a demo, please contact us.