Abstract
Background
People experiencing socioeconomic disadvantage are persistently underrepresented in clinical trials, yet they experience a significantly greater burden of disease than those not experiencing socioeconomic disadvantage. Trials need to be inclusive to ensure that treatments are safe and effective for those who need them most. Resources are needed to support researchers in designing and implementing trials that are inclusive of people experiencing socioeconomic disadvantage. Building on the National Institute for Health and Care Research (NIHR) INCLUDE initiative, we developed the INCLUDE Socioeconomic Disadvantage Framework to support researchers in making trials more inclusive.
Methods
The Framework was developed over five phases: (1) outlining an initial draft of the Framework, (2) refining the initial draft Framework with public contributors, (3) refining the draft Framework with wider contributors, (4) finalising the Framework with all contributors, and (5) launch and application of the Framework.
Results
The Framework entails four key questions: (1) Who should my trial results apply to? (2) Are people from different socioeconomic backgrounds likely to respond to the intervention in different ways? (3) Will my trial intervention and/or comparator make it harder for people from different socioeconomic backgrounds to take part in the trial? (4) Will the way I have planned and designed my trial make it harder for people from different socioeconomic backgrounds to take part? The Framework includes worksheets to support trial teams in considering strategies to address barriers to inclusion. In 2023, the Framework was launched at a webinar with ~300 registrants and is currently available to download from the Trial Forge website: https://www.trialforge.org/trial-diversity/socioeconomic-disadvantage-framework/. Public contributor considerations, collated through project meetings, to make trials more inclusive for people experiencing socioeconomic disadvantage are also appendaged to this article to support trial teams further.
Conclusion
The Framework and public contributor considerations can be used to support researchers to design and conduct more inclusive trials. Future work should include evaluation of such Frameworks, further engagement with funders to increase uptake, and development and evaluation of strategies to improve inclusion.
People experiencing socioeconomic disadvantage are persistently underrepresented in clinical trials, yet they experience a significantly greater burden of disease than those not experiencing socioeconomic disadvantage. Trials need to be inclusive to ensure that treatments are safe and effective for those who need them most. Resources are needed to support researchers in designing and implementing trials that are inclusive of people experiencing socioeconomic disadvantage. Building on the National Institute for Health and Care Research (NIHR) INCLUDE initiative, we developed the INCLUDE Socioeconomic Disadvantage Framework to support researchers in making trials more inclusive.
Methods
The Framework was developed over five phases: (1) outlining an initial draft of the Framework, (2) refining the initial draft Framework with public contributors, (3) refining the draft Framework with wider contributors, (4) finalising the Framework with all contributors, and (5) launch and application of the Framework.
Results
The Framework entails four key questions: (1) Who should my trial results apply to? (2) Are people from different socioeconomic backgrounds likely to respond to the intervention in different ways? (3) Will my trial intervention and/or comparator make it harder for people from different socioeconomic backgrounds to take part in the trial? (4) Will the way I have planned and designed my trial make it harder for people from different socioeconomic backgrounds to take part? The Framework includes worksheets to support trial teams in considering strategies to address barriers to inclusion. In 2023, the Framework was launched at a webinar with ~300 registrants and is currently available to download from the Trial Forge website: https://www.trialforge.org/trial-diversity/socioeconomic-disadvantage-framework/. Public contributor considerations, collated through project meetings, to make trials more inclusive for people experiencing socioeconomic disadvantage are also appendaged to this article to support trial teams further.
Conclusion
The Framework and public contributor considerations can be used to support researchers to design and conduct more inclusive trials. Future work should include evaluation of such Frameworks, further engagement with funders to increase uptake, and development and evaluation of strategies to improve inclusion.
| Original language | English |
|---|---|
| Journal | Trials |
| Early online date | 14 Jan 2026 |
| DOIs | |
| Publication status | E-pub ahead of print - 14 Jan 2026 |
Funding
Patient and public involvement in this project was funded by the University of Liverpool Returners/Early Career Researcher Fund. This work was supported by the MRC-NIHR Trials Methodology Research Partnership (MR/S014357/1).
| Funders | Funder number |
|---|---|
| Medical Research Council | MR/S014357/1 |
Keywords
- Socioeconomic disadvantage
- inclusivity
- trials methodology
- underserved groups
- trials
- conduct
- design
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