Integrated modeling of biomarkers, survival and safety in clinical oncology drug development

Thanks to the project Optimus, there is now more emphasis in oncology dose justification. In this context, model-based approaches clearly add value as they can answer many questions critical to drug development. This provides an overview of the possibilities MIDD approaches offer regarding imaging, circulating biomarkers models and safety, efficacy, and dropout models. It reviews the advantages and drawbacks of simultaneous and sequential fitting, and how all those models can be integrated together for answering key questions of oncology drug development. 

Looking ahead, oncology development without MIDD support will be at risk and have difficulty catching-up current drug development timelines settled by competition.