The ACCESS study

A collaborative study between CTUs and other researchers to identify the activities needed to improve the representation of under-served groups in trials and understand their implementation

On

ACCESS recommendations 

The ACCESS project has led to the development of the STEP UP (Strategies for trialists to promote equal participation in clinical trials for under-served populations) guidance which is freely available here: https://step-up-clinical-trials.co.uk/

Below is a link to an infographic listing the key recommendations. 

STEP UP recommendations (PDF, 789KB)

Background

Chief Investigator: Katie Biggs, University of Sheffield
Funding Body: NIHR

Clinical research rarely includes all of the people who benefit from the treatment being studied. This is a problem as the results may not apply to people who were not included in the research. This has happened in the last year in COVID research, with elderly and ethnic minorities, two groups of people more affected by COVID, being under-represented in vaccine and treatment trials. Groups that are regularly left out of the research are called “under-served” groups because the research has been designed in a way that does not serve them and their communities.

There is a current focus in research on trying to improve this. Clinical Trials Units (CTUs) can help by thinking about particular under-served groups in relation to the trials they are designing or managing. There is research into trying to make clinical research more inclusive but CTUs have not historically included a specific activity to improve representation in their trials, and may not know what activity can be included, or what it should cost. 

This project brings together researchers that work in CTUs and Universities who are keen to improve representation and undertake research in this area. We will work together to identify what activity can be done to improve representation in trials. 

Aims and objectives  

  • Review the literature to develop a list of activities/design features that have been effective in improving the representation of under-served groups in trials.
  • Undertake stakeholder meetings to explore the findings and gather further examples of activities that aim to increase representation from the stakeholders.
  • Redesign a number of case study trials to include the work needed to ensure these trials are including the necessary populations, including under-served groups.
  • Undertake further stakeholder meetings and interviews to explore facilitators and barriers to the implementation of activities or particular design features, and how barriers could be addressed.
  • Hold a meeting with collaborators and PPI members to determine best-practice guidance.
  • Develop a study within a trial (SWAT) proposal of an intervention that may improve the recruitment of a particular under-served population.

These objectives will be met through four work packages (WP):

WP 1: Scoping literature review

We will conduct a scoping literature review to identify examples of ‘good practice’ or activities that have been included in trials to improve representation, aiming to produce a ‘starter’ list of activities that could be included in a trial design. We will also assess if there is evidence for the effectiveness of these activities.

A draft Trial Forge Guidance document for recruiting and retaining ethnic minority groups will provide a solid starting point for ethnicity and be a model for other under-served groups. Through collaborators involved in the INCLUDE project, we will also build on the work done by NIHR Innovative Observatory for the INCLUDE project that identified innovations in the design and delivery of trials that enhance inclusion.

WP 2: Review literature findings in a roundtable discussion

Collaborators and PPI contributors will discuss the ‘starter’ list and other activities that can be done to improve inclusivity in trials. We will include researchers and PPI contributors with experience in a range of conditions and treatment types. This will provide us with a list of possible activities that can be integrated to improve inclusivity and could be used by CTUs to aid them in designing inclusive trials.

WP 3: Redesign of trials for enhanced inclusivity

Identification of 3 existing UK Phase 3 trials for which protocols are available. Trials will be selected to include a range of types of interventions.

A group with expertise in inclusivity and diversity in research, including study collaborators and PPI contributors, will review the protocols using the INCLUDE Ethnicity Framework or any companion frameworks relevant to the other population groups. Other similar frameworks are expected to be available from the TMRP covering other under-served groups by the time this project starts. The review process will aim to identify what could be done to improve the representativeness and diversity of the participants in the case study trials. The study team would then re-design the trials, detailing additional activities aiming to increase representation.

WP 4: Exploring the implementation of inclusive trial designs

Further stakeholder meetings, including further diverse PPI and people working in clinical research settings, will be held to explore facilitators and barriers to implementing these activities in trials, discuss potential solutions to the barriers and identify areas for further research.

Project timelines 

This project commenced on 1 October 2021

Funding

This study has been funded through the National Institute for Health Research (NIHR).

Study team

Katie Biggs - Lead Trial Manager - Chief Investigator - Clinical Trial Research Unit, The University of Sheffield - c.e.biggs@sheffield.ac.uk

Katie Hullock - Research Assistant - Clinical Trial Research Unit, The University of Sheffield - k.hullock@sheffield.ac.uk

Cindy Cooper - Director, Clinical Trial Research Unit, The University of Sheffield

Joy Adamson - York Clinical Trials Unit

Heidi Gardner - Health Services Research Unit, University of Aberdeen

Helen Hancock - Newcastle Clinical Trials Unit

Talia Isaacs - Institute of Education, UCL

Athene Lane - Bristol Clinical Trials Unit

Victoria Shepherd - Cardiff Clinical Trials Unit

Rebecca Maier - Newcastle Clinical Trial Unit

Frances Shiely - University College Cork

David Torgerson - York Clinical Trial Unit

Shaun Treweek - Health Services Research Unit, University of Aberdeen

Andrew Willis - University College Cork

Publications

Biggs K, Dix C, Shiely F et al. Effective interventions to increase representation of under-served groups in randomised trials in UK and Ireland: a scoping literature review [version 1; peer review: 2 approved]. NIHR Open Res 2024, 4:12

Related information

ACCESS Protocol (PDF, 131KB)