On 21st January 2025, over 50 stakeholders took part in the International Workshop on the Design and Implementation of Inclusive Clinical Studies, organised by SHINE 2Europe and held virtually. The event focused on the complexities of designing inclusive clinical studies within the context of four prominent research projects: RadioVal, Liveration, and AI4HF, funded by Horizon Europe, and REaDI, which is part of the Innovative Medicines Initiative. These projects all centre on clinical studies and trials in cancer and cardiovascular research.
Designing inclusive clinical studies presents numerous challenges, including time, human, and financial constraints, compounded by fragmented legal and regulatory frameworks and inconsistencies in data collection methods. These barriers place significant strain on professionals overseeing clinical studies. However, the risks of overlooking inclusivity are even more concerning: it can exclude underrepresented groups from critical research and, consequently, from access to optimal medical care.
The workshop brought together a diverse group of participants, including researchers, healthcare professionals, AI and IT developers, ethicists, regulators, policymakers, social scientists, and patients. The discussions focused on the primary obstacles to achieving more inclusive clinical studies, potential solutions, and the stakeholders who must collaborate to address these challenges.
Four high-level speakers presented the featured projects, offering insights into how diversity, equity, and inclusion are integrated into the design of these studies. They also shared how these principles will be further embedded during the implementation phases.
The participants were divided into three breakout groups, each focused on specific domains such as ethical, legal, social, technical, and organisational challenges related to inclusivity in clinical research. Each group prioritised the most pressing issues and explored potential solutions, identifying key stakeholders necessary to drive meaningful change.
Several key challenges emerged from the discussions, including:
- Literacy Barriers: Addressing health, digital, and traditional literacy to ensure that all participants can engage with clinical trials.
- Training: Providing diversity, equity, and inclusion (DEI) training for all stakeholders involved in clinical study design and implementation, particularly for clinical and research teams.
- Study Protocol Flexibility: Creating more adaptable protocols to encourage inclusion and accommodate a diverse range of participants.
- Access Inequality: Ensuring broader geographical access to trials, as many studies are conducted in urban or academic centres, limiting opportunities for rural populations or those from smaller towns.
A particularly urgent challenge identified was the limited time and funding available for clinical trials, which can severely hinder their execution. These constraints often lead to the exclusion of diverse participant groups due to logistical and financial barriers.
To address these challenges, participants proposed several solutions, including:
- Urging the European Commission to design funding calls specifically tailored to the unique needs of clinical trials, ensuring they address issues such as inclusivity and flexibility.
- Promoting greater collaboration among stakeholders to overcome organisational barriers and encourage more inclusive study designs.
- Leveraging innovative digital tools and integrating routine data collection to streamline patient selection, ultimately enhancing equity in clinical trials.
The workshop provided valuable insights into the complex challenges of designing and implementing inclusive clinical studies and highlighted the importance of collaboration among diverse stakeholders to create more equitable research environments. As the healthcare sector moves towards greater inclusivity, these discussions will play a pivotal role in shaping the future of clinical research.
