Project timeline

Where we are today

We have been working on mathematical techniques to make new clinical trial designs more legible. Michael demonstrates in his PhD thesis (100-page PDF here - chapter 5 is the relevant part) that for a large class of designs, if run large-scale simulations of a trial can be run, one can turn those simulations into a statistically rigorous proof about its Type I Error function [which is one of the biggest sticking points for FDA reviewers].

There are a few other requirements. For further information on the methodology see this seminar recording from May 2022, or slides from Michael's talk given to the FDA in September 2021.

Event

Barriers

Time

Initial use cases enter the FDA CID program

  • Specialized and optimized software delivered

  • Initial peer-reviewed paper to be published

+1-2 years

Specialized FDA teams de facto approve this approach

  • A number of peer reviewed papers published

  • FDA leadership engagement and support

  • Referenceable track record

+1-3 years

Typical drug development organization can use software

  • Typical FDA reviewer expected to accept

  • Execution risk and infrastructure for complex trials

  • Demand for complex trials grows

  • Low regulatory risk

  • Knowledge and comfort with use

  • Ecosystem of statistical methods

  • Accessible papers

  • Previous successes to point to

  • Engagement with all FDA reviewers

+2-10 years