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The SENSITISE Course

The SENSITISE online curriculum will incorporate novel content from experts in the domain, will emphasise the need to think more inclusively and will be complemented by innovative learning methods to help participants develop transferable skills and reasoning.  

The course is being developed for undergraduate biomedical and health professions students. It requires a minimum understanding of clinical trial design. If the learner does not possess this knowledge, a short prerequisite lesson will be made available.

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Course Breakdown

The curriculum will comprise 12 units divided into three overarching modules.  

The first module is an introduction to the subject matter covering the history of the topic, identification of the underserved groups and understanding of the barriers and cultural challenges. To conclude this overview on the subject the current legal and policy frameworks will be outlined.  

The second module focuses on inclusive design strategies in clinical trials. It highlights considerations on eligibility criteria and improved enrolment as well as monitoring and data usage. To close this module, case studies illustrate the importance of some of the key take home messages.  

The units in the third module analyse practicalities to consider for your inclusive trial. Among the considerations are how to engage with potential trial participants, recruitment and retention as well as post-trial communication. Lastly, the module will look at how to build links with underserved groups.  

Module 1

Setting the Scene

Unit 1: History of Inclusivity 
  • A brief history of inclusion within trials research including the role of ethics
Unit 2: Who Are Under-served Groups? 
  • Introduction to the concept of under-served groups as described by the NIHR-INCLUDE project
Unit 3: Understanding Barriers to Inclusion
  • Understanding of key inclusion barriers and their consequences
Unit 4: Case Study 
  • A case study focused on ethnicity/maternal mortality

 

Module 2

Inclusive Design

Unit 5: Who Do We Need in the Trial?
  • How eligibility criteria impact inclusion
Unit 6: Equitable Participation in Trials for Under-served Groups
  • How to increase equity, diversity, and inclusion through recruitment and retention
Unit 7: Inclusive Trial Design and Conduct
  • Best practices for monitoring trial inclusion, doing data collection, and full reporting
Unit 8: Case Study
  • A case study focused on adults who lack capacity

 

Module 3

Building for the Future

Unit 9: Building Links With Under-served Groups
  • Wider systemic issues related to building links with under-served groups
Unit 10: How to Be a More Inclusive Researcher
  • Best practices at the individual level for promoting inclusion in trials
Unit 11: Post-trial Communication 
  • Meaningful engagement and follow-through after a trial
Unit 12: Conclusion
  • Course wrap-up and further test material

Currently in development, the SENSITISE course will be made available as soon as possible. The materials will be translated and accessible in Czech, French and German. Moreover, to support the integration into existing university curriculum teacher guides will be made available to support onsite or hybrid integration of the materials to learn more about this visit the dedicated teacher guides page 

SENSITISE - Inclusive Clinical Trials: Training and Education

Co-funded by the European Union through the EU ERASMUS + programme (2023-1-IE02-KA220-HED-000159532),

The work by SENSITISE project consortium is licensed under CC BY 4.0

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