Trial design based on statistical modeling is likely to continue its rise in use given more frequent launches of adaptive trials, which suit dose-finding studies in particular. Trial design software maker Cytel has spotted this opening and launched Compass, a package for such studies based on frequentist or Bayesian methods.
Additional momentum for the use of modeling in clinical trials comes from recently installed NIH director Francis Collins, who advocates mastery of biostatistics for those working in biomedical research. "Not being able to understand a Bayesian analysis will no longer be tolerated," he says.
Compass provides a workflow for dose-identification study build using accepted adaptive methods, the company says. Its simulation engine quantifies design option decision-making. And visualizations of trial characteristics aid both researcher and regulator understanding of trial data.
Compass extends Cytel's solution portfolio: its East solution targets registration studies. And about a year ago, Cytel and the FDA's Center for Devices and Radiological Health joined forces to create Bayesian trial design and analysis software.
- here's the Compass release