# Making trials more inclusive of people experiencing socioeconomic disadvantage: developing the INCLUDE socioeconomic disadvantage framework

## TL;DR

This paper introduces a framework to help researchers design clinical trials that better include people from disadvantaged socioeconomic backgrounds.

## Contribution

The novel contribution is the development of the INCLUDE Socioeconomic Disadvantage Framework to improve trial inclusivity.

## Key findings

- The framework was developed through five iterative phases involving public and wider contributors.
- The framework includes four key questions and worksheets to address barriers to inclusion in clinical trials.
- The framework was launched in 2023 and is available for download on the Trial Forge website.

## Abstract

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.

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.

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.

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.

The online version contains supplementary material available at 10.1186/s13063-026-09448-2.