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Background: Globally, there are calls to improve the participation rates of traditionally under-served groups in clinical trials, including the elderly, ethnic minorities, pregnant and lactating women, and those with disabilities. In the absence of a relevant population, trial results cannot be generalised to all who could benefit. This perpetuates inequality and represents bad science. The topic of under-served groups in clinical research is widely recognised, but no formal training on trial inclusivity is available globally. Methods: An international, multidisciplinary team of trial methodologists, regulatory scientists, clinical pharmacologists, teachers and medical education researchers designed the curriculum, defined key topics and organised them in themed units. A teacher’s guide accompanies each unit to help to implement the curriculum in face-to-face, blended, or fully online settings. Additionally, workshop training materials and resources aimed at those working in clinical trials have been developed. Results: The SENSITISE training program is an online, open-access 12-week contextualised, case-driven curriculum on inclusive clinical trial research with additional workshop resources. The curriculum is available as a free, self-contained module in a learning management system for any individual, regardless of location, and importable into other systems. The detailed teacher’s guide assists teachers of different levels of expertise to take full advantage. It offers guidance and support on how to build different types of lessons using the materials, and tips for working with students with disabilities. All materials and teacher’s guides are available in English, French, German, and Czech. Conclusion: Training and education are important factors of a multipronged approach promoting diversity, equity, and inclusion in clinical research. As such, the SENSITISE training program is designed to effectively address the lack of inclusive clinical research education. Supported by ERASMUS+ SENSITISE (2023-1-IE02-KA220-HED-000159532).
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