Beyond Timelines: Modeling Strategic Levers in Clinical Development

2 months ago • Visible to anyone on or off LinkedIn

This is a new model I built for a training workshop last week, designed to showcase how we can build scenarios with different options and dynamics.

The model has two control variables.

The first is a Bernoulli variable that determines whether we receive fast track designation (or accelerated approval) for our treatment. If this variable is TRUE, we skip the Phase 3 duration and costs and go directly to registration after Phase 2. In this case, we also conduct the confirmatory trial specified in the model. Confirmatory success matters — if TRUE, sales continue as planned. If FALSE, sales stop when the confirmatory results are available.

The second control variable is a toggle called PH2 Use Clinical Parameters. If set to 0, we use the Phase 2 variables in the upper section of the form. If set to 1, we instead use clinical parameters to build up the Phase 2 duration based on recruitment rates, number of patients, and number of centers. The cost is then calculated as a function of the number of patients and centers and their respective unit costs. This creates a detailed clinical trial simulation where we can explore strategies such as speeding up trial timelines by adding centers or reducing treatment duration — at an associated cost.

The result is a model that supports clinical strategy testing. For example, we may adjust the Phase 2 CDP to increase the likelihood of securing fast track designation. This may involve higher costs but can shorten the time to market.

This is an example of using a model to generate strategic insight. The objective is to explore alternative approaches and trade-offs, rather than simply estimate how long the current plan will take.

Please share your thoughts in the comments.