Most clinical trials are designed to evaluate the relationships between single factors (eg treatment) and simple outcome measures. In today’s medical research, there is an increasing need for greater understanding and characterisation of effects of numerous factors on multiple outcome measures in heterogeneous patient populations. Clinical Trials are being asked to provide more information on safety, efficacy and long-term outcomes within the entire study population as well as within patient subgroups. Established statistical tools are limited in meeting this need.
We are developing software solutions that will enable the user to make better informed decisions during the design of smarter clinical trials. Created as an aid to optimise the design and analysis of clinical trials in a virtual environment, KERUS™ guides users through the design process via a simple intuitive interface. The software allows users to evaluate large numbers of virtual study design and analysis options using both real and user-defined data without the need for a technical knowledge of modelling.
KERUS™ is designed specifically to enable study simulations involving multiple correlated outcomes. This concept has broad application in clinical research including the design of studies for stratified medicine and subgroup analysis, biomarkers and surrogate endpoints, benefit-risk analysis, diagnostic development, health technology assessment and comparative effectiveness research.
The result is a statistically rigorous assessment of study design that has the power to answer multiple questions simultaneously. With KERUS™, we aim to offer an exceptional software tool that can ensure users have the best clinical study design to maximise the chances of success. It allows the user the confidence to ask more of their clinical trial.