Evidence
Alert

INCLUDE Roadmap can help researchers make trials more inclusive

Many groups – such as women, older people and ethnic minorities – are under-served in clinical trials. An NIHR project aims to ensure that health research includes the people who most need it.

The project is called Innovations in Clinical Trial Design and Delivery for the Under-served (INCLUDE); the current research formed the first phase of the project. The INCLUDE team gathered information from literature reviews, surveys and workshops. They outlined the key characteristics of under-served groups and identified barriers to taking part in research.

INCLUDE’s advisory group created a plan, or Roadmap, and made recommendations for improving access to clinical research.

What’s the issue?

People recruited into clinical research often do not represent those most in need. For example, people taking part in heart failure trials are 20 years younger on average than real-life patients. Patients in cancer trials tend to have no other conditions, and those in diabetes trials are not the ethnically diverse populations typically seen in practice.

This disconnect results in problems, including:

  • benefits and side effects of treatments may not translate to real-world patients
  • trial interventions may not be deliverable or applicable to all groups of patients
  • the risk of overlooking important findings specific to different populations
  • lack of inclusion discriminates against some groups.

There is currently no systematic approach to overcoming the lack of representation in clinical trials.

The NIHR set up INCLUDE to make research more inclusive and representative of the people who need it.

INCLUDE aimed to clarify which groups are under-served in health research, and the reasons for it. The project team then identified ways of addressing the issue.

What’s new?

The INCLUDE team reviewed 58 papers on under-representation in clinical trials. 70 stakeholders from under-served groups and 101 clinical professionals gave their views on under-representation through online surveys. The team also ran three workshops with key stakeholders from funding, design, delivery and patient groups.

The literature review confirmed that under-served groups include women, older people and ethnic minorities, among others. It found that studies often do not collect the information that is needed to make a judgement on whether a group is under-served.

The researchers identified barriers to representation. These included logistical barriers (such as lack of transport), inaccessible information, low engagement with healthcare services and low awareness of clinical trial opportunities.

Prior to this project, there was no widely accepted term to describe these groups. The project established the preferred label - ‘under-served’ - but did not define it because a specific definition may not capture all relevant groups. Instead, it identified the key characteristics common to under-served groups:

  • lower inclusion in research than expected from the numbers of population
  • high healthcare burden not matched by the volume of research for the group
  • important differences in how a group responds to or engages with healthcare interventions compared to other groups.

Why is this important?

The INCLUDE steering committee used the findings from the literature review, surveys, and workshops to create a strategic Roadmap. It is intended as a guide to help researchers work with under-served groups and to improve their access to clinical research.

INCLUDE has identified the following priorities for achieving more inclusive research:

  • Embedding research within healthcare to improve access
  • Providing resources and training to build capacity and increase engagement
  • Educating funders to understand and address the barriers to research
  • Building long-term relationships between researchers and under-served groups so that patients can be placed at the centre of the research process
  • Creating a nationwide publicity drive about clinical trials and why they matter
  • Establishing a baseline to help better understand and address the situation.

Improving the inclusion of under-served groups in research will require the involvement of all stakeholders: patients, the public, funders, clinicians, researchers, regulators, industry and policymakers. Funding, policy and regulatory barriers to inclusion need to be removed. Systems need to be put in place to recruit and retain participants from under-served groups.

What’s next?

The group is developing resources to support the recruitment of under-served groups. They want to continue raising awareness of INCLUDE with funders, researchers, industry and participants. The Wellcome Trust, another prestigious funder independent of NIHR and INCLUDE, has incorporated INCLUDE guidance into its clinical trials policy.

The INCLUDE team are using the guidance to develop infographics for patients, a toolkit and an online course for researchers.

They are expanding the INCLUDE website to share more examples of good practice, innovative research, and ways of undertaking inclusive health research.

You may be interested to read

The full paper: Witham MD, and others. Developing a Roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process. Trials. 2020;21:694

INCLUDE project website: Better Healthcare Through More Inclusive Research

Background information about the INCLUDE Ethnicity Framework

NIHR Guidance from the INCLUDE project: Improving inclusion of under-served groups in clinical research. 2020

NIHR Guidance from the INCLUDE project: Ensuring that COVID-19 research is inclusive. 2020

Funding

This research was funded by the NIHR Clinical Research Network Coordinating Centre.

Commentaries

Study author

There was no consistent definition of under-served groups when we began the research. Our work has highlighted how diverse the meaning of this phrase can be. It also places the onus on the research community to reach out to under-served communities to address the problem. The urgency to do so has never been clearer.

The Roadmap will help clinical researchers apply INCLUDE principles to individual studies.

We’ve also created guidance to help funders, researchers and delivery teams improve inclusion of under-served groups as they design and assess clinical research proposals. We’ve tailored a separate piece of guidance to ensure inclusive design and delivery of COVID-19 research.

Lynn Rochester, Professor of Human Movement Science, Newcastle University

Nurse researcher

This paper sets out the need for inclusion of under-served groups and an agenda for change.

The INCLUDE Roadmap is a resource for organisations that support the design and delivery of trials across the UK. It will help create practical initiatives to increase inclusion from trial design through to delivery. It could form the basis of awareness-raising campaigns and targeted messages to professionals, patients and the public.

More direct measures might include an NIHR webinar and direct messaging to clinical trial units and other research organisations.

Victoria Shepherd, Nurse Researcher and Research Associate, Centre for Trials Research, Cardiff University

Member of the public

This is a significant first step to address issues that have been highlighted by the impact of the COVID-19 pandemic on BAME households and care home residents. It raises awareness of poorer service provision for under-served groups and poorly-targeted services and resources. It demonstrates commitment to those in under-served groups and could lead to effective service provision from better-informed service providers through improved training and the identification of bias and institutionalised prejudice.

Stakeholders from under-served groups need to be involved at an early stage. Time and money issues need to be addressed so that costs for lost earnings, travel and childcare expenses are covered. Marketing in plain language, in minority languages, or in a format appropriate for people with learning disabilities, would help. The general publicity has to tie in with the need to demonstrate commitment to these groups.

Ian Hill, Belper, Derbyshire, attended stakeholder meetings for INCLUDE

Conflicts of Interest

None declared.