The Trial Simulator software supports a variety of trial designs, including parallel, n-by-n Latin square, and crossover designs with any number of treatment groups and periods, explained Certara Chief Commercial Officer Ellen Leinfuss.
“The study enrolls subjects from one or more study centers, each of which may draw subjects from a different subpopulation with different covariate distributions,” she told us.
“Subjects may be screened for trial inclusion based on covariate values and/or responses measured during an optional lead-in phase.
“Active phase treatments and observations may include any number of doses and measurements, scheduled at specific times or using a recurring cycle of times. Trial Simulator supports adaptive dosing schemes and covariate or response based dose adjustments,” Leinfuss said.
The US Food and Drug Administration (FDA) recently released draft guidance on the use of adaptive design in clinical trials. The adaptive design draft guidance advises industry on the types of information FDA needs to evaluate the results from clinical trials with adaptive designs. This includes Bayesian adaptive designs and complex designs relying on computer simulations.
The European Medicines Agency (EMA) also recently updated its first-in-human (FIH) recommendations, which Certara’s quantitative systems pharmacology (QSP) approach builds on. The company earlier this year outlined the role of QSP in FIH clinical trial design in a “Letter to the Editor.” The EMA responded, welcoming the initiative shown and encouraging the use of mechanistic models.