By Clinical Informatics News Staff

November 29, 2018 | Certara has announced the launch of version 2.3 of its Trial Simulator software to help drug developers improve clinical trial design, resulting in greater likelihood of trial success. By allowing users to model and simulate different clinical trial scenarios, Certara’s Trial Simulator allows them to identify and assess risks and preview the range of expected results before millions of R&D dollars are spent and human subjects are exposed to experimental therapies.

Drug development teams can use Trial Simulator, together with existing drug knowledge, to answer highly pertinent questions such as: How likely is this trial to succeed? What is the optimal dosing and treatment schedule for a particular indication? What is the expected range of responses across doses? How will a change in patient inclusion/exclusion criteria affect outcomes? Can we shorten the trials or reduce the number of patients in the trials?

Today, nine out of ten drugs in development fail to make it to market, costing pharmaceutical companies billions of dollars every year. Even the majority of drugs that get to Phase 3, do not get approved. One reason for trial failures is suboptimal trial design.

“Certara’s Trial Simulator is a trusted solution that has been used by leading pharmaceutical companies for more than a decade to optimize their clinical trial design and maximize their probability of trial success,” Thomas Kerbusch, president of Certara Strategic Consulting Services, said in a press release. “But as these trial failure rates testify, we need to increase awareness of trial simulation’s capabilities and broaden its adoption. Meanwhile, we continue to enhance Trial Simulator both to support our loyal customers and ensure that the platform continues to meet their evolving needs.”

With Trial Simulator, drug development teams can define study design attributes, conduct statistical and sensitivity analyses, and create graphical summaries of their work. They gain access to Certara’s extensive library of pre-built pharmacokinetic, and pharmacokinetic/pharmacodynamic (PK/PD) models, which allows them to rapidly build population-based drug and disease models that describe drug actions over time in specific subjects. They can even create novel study designs and compare different development strategies. With Trial Simulator, users can share their scientific knowledge, test ideas, and plan the most relevant, effective clinical trials.