Simulator provides early view of trial operations

Four major drug companies are using a simulation package at the planning stage of their clinical trials to study trial design operating characteristics, and one may soon be using the tool on 90 percent of its drug development portfolio. Makers of the Fixed Adaptive Clinical Trial Simulator, who released version 2 of the FACTS software last month, say they believe it could boost the overall use of trial simulation across the drug development sector.

The software, which of course lets users evaluate various trial designs, also lets them simulate the impact of different dose response profiles, trial accrual rates, and subject drop rates on likely trial outcome. FACTS 2 follows its Bayesian dose-finding and -escalation predecessor, announced in May 2009 by collaborators Berry Consultants and U.K. consultancy Tessella.

FACTS 2 can simulate multiple-endpoint dose-finding trials, and it lets users scale the efficacy value of a drug by a safety factor that reduces the utility of a dose when side effects exceed a threshold. It can also be used to simulate time-to-event trials and can help researchers consider the benefits early stopping, dropping ineffective arms and adaptive randomization.

Simulation software for early-stage study of a trial design's operating characteristics has been on the good-in-principle list but not the purchase-now list of the typically cautious drug development community, according to eClinqua. And that's despite the FDA's signaled acceptance of the technique in draft guidance on adaptive trials.

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