On January 21, 2025, SHINE 2Europe hosted the International Workshop on Designing and Implementing Inclusive Clinical Studies. The event brought together over 50 participants from diverse fields, including researchers, healthcare professionals, AI developers, regulators, and patients, all focused on one crucial goal: ensuring inclusion in clinical trials.

Clinical studies are essential for developing effective treatments, but achieving inclusivity remains a challenge. Limited resources, fragmented regulatory frameworks, and rigid study designs often exclude underrepresented groups, leading to disparities in access to medical advances. Addressing these issues was at the heart of the workshop discussions.

Key Challenges

Participants identified several barriers limiting inclusion in clinical studies, including:

  • Health and digital literacy: Many individuals lack the tools to fully understand or participate in trials.
  • Geographical access: Studies are often conducted in urban centers, excluding rural populations.
  • Equity training: Clinical and research teams often lack specific training on diversity and inclusion.
  • Protocol rigidity: Inflexible study designs hinder diverse participation.
  • Limited resources: Time and funding constraints directly impact inclusive strategies.

Proposed Solutions

Workshop participants recommended several practical solutions, including:

  • Designing funding calls that address the specific needs of inclusive clinical studies.
  • Promoting cross-sector collaboration to overcome organizational barriers.
  • Implementing digital tools and leveraging routine data collection to ensure greater equity.
  • Providing diversity, equity, and inclusion training for all stakeholders involved.

Highlighted Projects

The presented projects showcased how inclusion and diversity can be integrated into clinical studies:

  • RadioVal: Using AI for inclusive cancer diagnostics.
  • Liveration: Innovating treatments to reduce liver cancer recurrence.
  • AI4HF: Applying AI in heart failure treatment.
  • REaDI: Developing innovative frameworks for inclusive trials.

Commitment to the Future

The workshop concluded with a call to action: inclusion is not just desirable but essential to ensure that clinical research benefits everyone. In the coming weeks, the full results of the event will be analyzed and shared with stakeholders. From SHINE 2Europe and the participating projects, we reaffirm our commitment to equity and innovation. Together, we can build a more inclusive future!

 

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