Università degli studi di Modena e Reggio Emilia

When inclusion becomes a quality parameter: the EQUITRIAL framework developed by Unimore featured in Nature Medicine

Nature Medicine has published the article “Embedding equity in clinical research governance”, which addresses one of the most significant and debated challenges in contemporary clinical research: inclusivity. The study, led by Johanna Maria Catharina Blom, a member of the Department of Biomedical, Metabolic and Neural Sciences at the University of Modena and Reggio Emilia, highlights the work of the Modena-based research group engaged in topics such as health data governance, research ethics, and regulatory innovation at the European level.

The scientific contribution emerges from a research group in which Unimore also plays a leading role in coordinating the European consortium FACILITATE, dedicated to returning health data to participants in clinical studies. It was precisely the experience gained through FACILITATE that enabled the team to develop a practical and operational approach to inclusion in trials, moving beyond the purely declarative nature of ethical principles.

“The underlying problem is well known yet still unresolved,” explains Prof. Johanna Maria Catharina Blom of Unimore. “Many clinical studies do not adequately represent the real population. Certain groups are systematically underrepresented on the basis of age, sex, disability, socioeconomic status or migrant background. This is not merely a matter of social justice: it directly affects scientific quality. If samples do not reflect reality, results risk being less reproducible and less applicable to clinical practice. Moreover, these same imbalances may be transferred into artificial intelligence systems applied to medicine, amplifying existing biases.”

The paper published in Nature Medicine proposes a shift in paradigm: representativeness should not be viewed merely as an ethical aspiration but must become a measurable and verifiable parameter, on par with other research quality standards. The framework developed by the Unimore group, named EQUITRIAL, introduces a structured model that analyses — at individual, contextual and cultural levels — the structural dimensions of inclusion and exclusion processes within a clinical trial. Two synthetic indicators are now integrated: the representation ratio, which compares the sample composition with external reference data (such as the actual disease burden), and the intersectionality score, which measures the cumulative risk of exclusion when multiple vulnerability factors overlap.

“One of the qualifying features of the project,” continues Prof. Blom, “is its focus on operational sustainability. The proposed inclusion plan can be integrated into the annexes already required in study protocols, using data that are normally collected. The framework also includes the presence of a trust liaison officer, a role that evolves from existing patient-relations functions and is responsible for monitoring inclusion commitments and maintaining an active dialogue with the communities involved.”

The experience gained through FACILITATE played a decisive role in defining the concept of ‘equity as metadata’ : integrating representativeness indicators directly into the digital infrastructures of trials, allowing near real-time monitoring of inclusion. Returning data to participants and ensuring transparency in how they are used strengthens trust and turns citizens into informed protagonists of scientific and clinical research.

“Over the next two years,” concludes Prof. Johanna Maria Catharina Blom, “our research group at Unimore aims to test the inclusion plan in trials regulated by the European Union, develop representativeness benchmarks for different therapeutic areas, and promote tools for public monitoring. Our ambition is to help define a European standard capable of combining scientific quality, evidentiary reliability and social justice.”

With this work, Unimore confirms itself as a reference point in the international debate on clinical research governance, offering a model that transforms inclusion from an abstract principle into a concrete criterion of scientific quality.

Categorie: International - english, Notizie_eng