Clinical trials require an enormous investment. However, even the best, most important, and most innovative drug, biologic, or medical device may not make it to market if its clinical trial is poorly designed, underpowered, or overly sensitive to deviations from design assumptions.
TrialDXSM is a service offered by ConfluenceStat, LLC, to independently evaluate clinical trials for investors or potential investors. In short, we believe the first time you run a clinical trial should never be the actual time you run the clinical trial.
We use clinical trial simulation to evaluate design assumptions: to replicate power and sample size calculations and to perform sensitivity analyses and stress tests on the design. Our independent analysis scores the reliability of the design assumptions and provides a detailed description of predictive probabilities of trial success for deviations from those assumptions.
Sample size calculations are typically performed under ideal assumptions using asymptotic theory. Using simulation, we can accurately replicate the real-world setting, factoring in crossover, missing data, noncompliance, and other concerns tailored to the trial. We will illustrate how sensitive the trial is to each of these potential pitfalls, and to combinations of these potential pitfalls.
TrialDXSM allows you to conduct your trial, or a trial in which you are considering investing, in silico, and to quantify its strengths and weakness before you conduct or fund the actual trial. This enables you to evaluate the trial’s strengths and weaknesses, build in adaptations to protect against incorrect assumptions, or evaluate your potential investment.
TrialDXSM simply lets you execute your trial millions of times, learning from each one, before the enormous monetary and time investment to execute the trial in patients.