Simulation: A Critical Tool in Adaptive

PhotoGraphy: Bruce Laurance, Getty Images Illustration: Paul A. Belci
In recent years there has been increased industry interest and utilization of adaptive clinical trials. Although the term "adaptive" covers a large range of study features and designs, much of the current excitement is around designs that enable treatment groups to be dropped during the trial to enable more doses to be investigated and/or to reduce time between development phases using seamless designs.

Perhaps the most interesting of these applies to dose finding, where critical decisions regarding the dose to take forward into Phase III is sometimes made on limited information due to practical limitations regarding number of doses that can be investigated in Phase II studies. Taking a suboptimal dose into Phase III can result in having to repeat studies with different doses or can lead to incorrectly terminating development.

Of those drugs that finally reach the market, it is estimated that one in five is launched with a flawed dosage,1 which can be expensive when discovered after pricing and reimbursement details have been agreed upon.