The PRIME-ROSE study

Background

A significant portion of patients with advanced cancer who have exhausted standard treatment options have an actionable mutation for which targeted therapy is registered outside the corresponding indication. The DRUP study provides these patients access to targeted therapy of precision cancer medicine outside their labelled indication. This study has proven successful and has been implemented across multiple countries in Europe in recent years. PRIME-ROSE will combine these DRUP-like trials to assess clinical benefits of actionable mutations. Because these are not randomized controlled trials there exists only a treatment group. In the PRIME-ROSE project, a synthetic control group is created from multiple sources that resembles a randomized control trial.

Aims

The aim of PRIME-ROSE is to enable cross-border data sharing by combining the data from DRUP-like trials in Europe. To assess clinical benefits, the project builds synthetic randomized trials that resembles a randomized control trial. Furthermore, it plans to design and conduct pragmatic clinical trials, provide the necessary data for implementation, involve patients in a consistent and meaningful manner, focus on multi-stakeholder collaboration and continuous knowledge transfer and training of DRUP-like trials.

Team

• Prof.dr. M. Fiocco, Mathematical Institute Leiden University, Department of Biomedical Data Sciences Leiden University Medical Center & Princess Máxima Center for Pediatric Oncology 

• Prof.dr. H. Gelderblom, Department of Medical Oncology at the Leiden University Medical Centre 

• Dr. E.C.K. Pagui, Oslo Centre of Biostatistics and Epidemiology

• H. van der Pol,  MSc, Department of Medical Oncology at the Leiden University Medical Centre & Mathematical Institute Leiden University

PRIME-ROSE website

Here is the official website of the PRIME-ROSE study: https://www.matrix-fkb.no/en/prime-rose/home