Pharmaceutical Market Europe • May 2025 • 29

TRENDS

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Building inclusive clinical trials through policy reform

Despite long-term consensus on the importance of diversity and inclusion in clinical trials, many populations remain underrepresented. There are multiple reasons why these inequities persist, but one is often location. Clinical trial centres are concentrated in city hospitals in economically developed countries, with limited information about or support to reach them for people in more remote or underserved communities.

Many companies are working globally to widen access to clinical trials through initiatives in research and development, medical and patient engagement. However, now more than ever, policy engagement is vital to ensure political and health system environments also support increased diversity.

Snapshot of policy enabling change
Hub-and-spoke models, supported by digital tools like remote monitoring and telemedicine, are helping extend access to clinical trials through real-time communication and data sharing between central trial centres and local sites. These models are bringing research closer to patients, making participation more feasible for historically excluded populations.

Policy has a vital role in realising the potential of this decentralised approach. By investing in data infrastructure, workforce training and communication platforms, governments can empower specialist centres to run remote trials. In Australia, government initiatives like TrialHub are already leading the way in achieving this and could serve as a blueprint for further action globally.

This investment must be accompanied by regulatory frameworks that incentivise innovation – clarifying rules on data use, privacy and cross-border collaboration. The European Health Data Space has the potential to deliver some of these benefits and improve how health data is used and shared across the EU.

Looking ahead
Although more inclusive trials are within reach, progress could risk being derailed by growing political pushback against diversity initiatives. Representative clinical trials are essential to good science and maintaining trust in medicines, so it’s vital that companies stay the course. By embracing innovative models and investing in policy reforms that enable them, we can create a research ecosystem that truly reflects the populations it serves.

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Catarina Casella is Associate Director at Incisive Health

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