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Innovations in Clinical Trial Design and Delivery for the Under-served (INCLUDE)

NIHR funding helps to support infrastructure and delivery of research involving under-served groups. The INCLUDE Project (Innovations in Clinical Trial Design and Delivery for the Under-served) is one of a suite of large scale projects in key areas of innovation. The project is led by the NIHR Clinical Research Network (CRN).

​​In 2017, the National Institute for Health Research commissioned the project to improve the inclusion of under-served groups into clinical research. It was recognised that there are groups of people in society who are not normally included in research (or are not included as much as they should be). INCLUDE, along with other innovative projects, has led to the development of resources for researchers, health and care professionals, patients and the public.

What we do

The INCLUDE framework

Since the INCLUDE project started, a series of scoping reviews, surveys and stakeholder events have been undertaken. This input from multiple stakeholders resulted in the INCLUDE framework. The framework is a combination of a roadmap, as well as the project’s core objectives and work streams.

The roadmap shows when it might be possible to include under-served groups throughout the course of research. We also need action at a national level by stakeholders to help with regulations, funding and governance. This is to make sure there is a supportive environment for researchers to include under-served groups.

The objectives and workstreams highlight what the project is aiming to do and how those objectives will be achieved.

The core objectives are:

  • develop Community Partnered Participatory Research building long-term relationships and opportunities for under-served groups to participate
  • develop tailored training resources to design and delivery trials for under-served groups
  • develop infrastructure and systems to reach, engage, recruit and retain under-served groups
  • working with funders, regulators and other stakeholders to remove barriers to including under-served groups in clinical trials

The workstreams are:

  • communications and training
  • infrastructure, people and processes
  • design tools
  • funder and regulatory landscape

What do we mean by ‘under-served’ groups?

The INCLUDE project settled on the term ‘under-served group’ as the term preferred by stakeholders – most particularly by those from under-served groups. The term reflects the perspective that the research community needs to provide a better service for people in these groups. The lack of inclusion is not due to any fault of the under-served.

Some key characteristics that are common to several underserved groups are:

  • Lower inclusion in research than one would expect from population estimates.
  • High healthcare burden not matched by the volume of research designed for the group.
  • Important differences in how a group responds to or engages with healthcare interventions compared to other groups, with research neglecting to address these factors.

The key idea is that the definition of ‘under-served’ is highly context-specific. It depends on the population, the condition being studied, the question being asked by research teams, the context in which potential participants live (care homes, prison etc), and the intervention being tested. No single, simple definition can encompass all under-served groups.

How the NIHR supports inclusive research

The NIHR is actively committed to supporting and promoting equality, diversity and inclusion in research. We are working with partners to achieve this and foster a more inclusive environment through improved research design and delivery, and ensuring effective patient and public involvement and engagement. To find out more about the Equality Diversity and Inclusive Research Initiative, visit our Equality, Diversity and Inclusion page.

Further information

Videos

Related studies

Support and resources

The resources that have come out of the INCLUDE project are aimed at helping researchers, funders and regulators a useful framework for including under-served groups in the design and delivery of their studies.

The INCLUDE general guidance summarises what an under-served group is, provides a roadmap suggesting intervention points to improve inclusion, examples of under-served groups and example barriers to inclusion. It then provides a suggested framework of questions to guide the deliberations of funders, researchers and delivery teams as they design and assess clinical research proposals. It ends with examples of good practice and other resources to guide teams seeking to engage with, and improve inclusion of, under-served groups in clinical research.

The resource tracker provides links to articles, websites and case studies in various areas such as recruitment, PPIE, older people, social disadvantage etc. which might be useful to researchers when designing and delivering their studies.

Inclusive COVID-19 research

COVID-19 is challenging health systems globally. While in the UK, the pandemic has triggered an unprecedented research response. Across the UK, teams are designing and delivering studies across a range of COVID research - encompassing epidemiology, disease surveillance, disease consequences, early and late phase clinical trials. Early evidence suggests that some segments of the population are at high risk either of contracting COVID or of more severe consequences from the disease including hospitalisation and death. Some of these groups are not well reached by standard research design and delivery mechanisms, and there is growing concern that some of the groups most vulnerable to the impact of COVID are under-represented in research studies.

This guidance is designed to facilitate best practice in the design, funding, approval, regulation and delivery of research on COVID-19. It is a product of the ongoing NIHR INCLUDE project that seeks to improve research for under-served groups.

Guidance documents:

Improving inclusion of under-served groups in clinical research: Guidance from INCLUDE project

Ensuring that COVID-19 Research is Inclusive: Guidance from the NIHR CRN INCLUDE project

Learning resources 

We have collated a selection of different web links, resources, papers, guides and more to facilitate inclusive health research at the INCLUDE Google site.

Experts

INCLUDE Project

INCLUDE is a collaborative effort involving researchers, health professionals, funders, charities, participants, families and carers, regulatory bodies, the life sciences industry and colleagues from across the NIHR and Clinical Research Network. The project has benefitted from having the strategic input of an expert steering group comprising members from across our stakeholder groups.

We worked very closely with the NIHR Innovation Observatory in the early stages on horizon scanning and literature reviews on the subject, to establish the initial evidence base informing the project’s scope and direction. Through our subsequent workshops and events we have worked with colleagues from across the country to highlight the patient experience - in addition to seeking input from researchers and clinicians around developing and delivering research for under-served groups.

Following this work, the term ‘underrepresented’ - which was initially used - was changed to ‘under-served groups’. This puts a greater onus on those leading, developing and delivering research as the individuals responsible for enhancing engagement (and not those classed as under-served). Stakeholders agreed that it is the responsibility of those working within the healthcare setting to actively consider and/or engage with groups who are not considered or sufficiently catered for in terms of clinical trial design and delivery.

INCLUDE Steering Group

Chair: Professor Lynn Rochester

The INCLUDE Project Steering Group is led by Professor Lynn Rochester, Specialty Cluster (Ageing, Dementias and Neurodegeneration, Neurological disorders and Genetics) and Alliance Lead at the NIHR Clinical Research Network.

Steering Group Members

  • Prof Lynn Rochester (Chair) – National Specialty Cluster E Lead, NIHR CRN
  • Laurie Oliva – INCLUDE Patient and Public Involvement and Engagement Lead, and Head of Public Engagement and Involvement NIHR CRN
  • Dr Camille Carroll – National Specialty Lead Neurodegeneration, NIHR CRN
  • Theo Christie – Business Development Manager, NIHR CRN
  • Prof Paul Dark – Chair in Critical Care Medicine, Manchester University
  • Prof Alistair Hall – Clinical Director, CRN Yorkshire and Humber
  • Prof Helen Hancock – Co. Director, RDS NE
  • Dr Jennifer Harris – Medicines Development Policy Manager, ABPI
  • Dr Joanna Knee – Head of Research Operations, NIHR CRN
  • Prof Eamonn Maher – National Specialty Lead Genetics, NIHR CRN
  • Rebecca Maier – Deputy Lead, Newcastle Clinical Trials Unit
  • Dr Gary Nestor – Assistant National Specialty Cluster E Lead, NIHR CRN
  • Prof John O’Brien – National Specialty Lead Dementias, NIHR CRN
  • Prof Sue Pavitt – Professor of Translational & Applied Health Research, University of Leeds
  • Prof James Wason – Professor of Biostatistics, IHS BRG
  • Dr Jane West – Director of Public Health Research, Bradford Institute for Health Research
  • Prof Miles Witham – Professor of Trials for Older People, Newcastle