Innovation in Trial Design & Delivery for the Underserved

From the NIHR

17/12/2021

NIHR Clinical Research Network National Specialty Lead for Ageing, Professor Miles Witham, explains the purpose, strategy and objectives of the INCLUDE project that aims to ensure that clinical trial design and delivery takes into account the needs of underserved groups amongst our population.

INCLUDE Roadmap can help researchers make trials more inclusive

Published on 9 November 2020doi: 10.3310/alert_42357

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. Previous research has found that 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.