Core variables for real-world clinicogenomic data collection in precision oncology

Abstract

Background

Precision oncology evidence gaps may be bridged using real-world clinicogenomic data; however, current limitations compromise real-world data collection and evidence generation. We aimed to define a set of precision oncology core variables that can aid in fit-for-purpose real-world data collection to be used for a range of purposes and by various stakeholders based on the approach adopted when designing the WAYFIND-R registry (NCT04529122).

Materials and methods

A panel of precision oncology experts created a list of variables based on standard dictionaries and vocabularies, which was aligned with the European Medical Agency’s draft guidelines for registry-based studies. A list of core variables was selected from the initial broad list of variables.

Results

The initial overall list (∼500 variables) was consolidated to ∼150 variables that covered the entirety of the patient journey in oncology. The panel gave highest priority to patient demographics, socioeconomic information and comorbidities, cancer details, molecular information, particularly predictive biomarkers in routine use and next-generation sequencing technical aspects, systemic cancer therapies and other treatments, outcome assessments and survival outcomes.

Conclusions

The core oncology variables represent a harmonized list of key clinicogenomic data elements that can be collected during a patient’s journey in oncology and leveraged for their primary intended purpose of molecular tumor board decision making, and might be used for further secondary research purposes, if legal requirements allow. Definition of this list of core variables will help generate evidence from research- or regulatory-oriented precision oncology studies by ensuring synergy, dataset connectivity, and interoperability across different data.