The PRIME-ROSE consortium is moving the field of precision cancer medicine forward through its European network of 11 DRUP-like clinical trials. These trials focus on biomarker-driven treatments for various tumour types, exploring therapies beyond their current labels to improve patient outcomes.

By harmonising and standardising clinical data using the OMOP system, PRIME-ROSE enables merging of patient cohorts with shared tumour types, biomarkers, and drug combinations. This collaborative approach, currently covering a recruitment area of 71 million people, accelerates evidence-building and enhances patient care. Data from trials, including FINPROVE (Finland), ProTarget (Denmark), IMPRESS-Norway (Norway), MOST-trials (France), DETERMINE (UK),and DRUP (The Netherlands), have already been integrated for analysis.

Cohorts of eight patients are evaluated for clinical benefit defined as a confirmed objective response or stable disease for at least 16 weeks. Cohorts showing clinical benefit in at least one patient, advance to stage II, expanding to 24 patients. The recruitment status to each cohort is shared in monthly meetings, together with discussions on expansion of filled cohorts.

Currently, 805 patients have been included in shared cohorts, and 200 cohorts have been merged between trials. Moreover, 22 cohorts have been filled in Stage I and subsequently been expanded to Stage II within the network. Finally, 3 cohorts have so far been filled in Stage II and are currently undergoing data analysis.

This pioneering effort demonstrates that harmonising clinical data across DRUP-like clinical trials is not only feasible but also significantly boosts cohort recruitment. The next step in this data sharing effort will be to expand beyond DRUP-like clinical trials to similar precision cancer medicine trials in Europe and globally.

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