Developing a roadmap to improve trial delivery for underserved groups: results from a UK multi-stakeholder process

Abstract

Background Participants in clinical research studies often do not reflect the populations for which healthcare interventions are needed or will be used. Enhancing representation of underserved groups in clinical research is important to ensure that research findings are widely applicable. We describe a multicomponent workstream project to improve representation of underserved groups in clinical trials. Methods The project comprised three main strands: 1) a targeted scoping review of literature to identify previous work characterising underserved groups and barriers to inclusion; 2) surveys of professional stakeholders and participant representative groups involved in research delivery to refine these initial findings and identify examples of innovation and good practice; 3) a series of workshops bringing together key stakeholders from funding, design, delivery and participant groups to reach consensus on definitions, barriers and a strategic roadmap for future work. The work was commissioned by the UK National Institute for Health Research Clinical Research Network. Output from these strands was integrated by a steering committee to generate a series of goals, workstream plans, and a strategic roadmap for future development work in this area. Results ‘Underserved groups’ was identified and agreed by the stakeholder group as the preferred term. Three-quarters of stakeholders felt that a clear definition of underserved groups did not currently exist; definition was challenging and context-specific but exemplar groups (e.g. those with language barriers or mental illness) were identified as underserved. Barriers to successful inclusion of underserved groups could be clustered into: communication between research teams and participant groups; how trials are designed and delivered, differing agendas of research teams and participant groups; and lack of trust in the research process. Four key goals for future work were identified: building long-term relationships with underserved groups; developing training resources to improve design and delivery of trials for underserved groups; developing infrastructure and systems to support this work, and working with funders, regulators and other stakeholders to remove barriers to inclusion. Conclusions The work of the INCLUDE group over the next 12 months will build on these findings by generating resources customised for different underserved groups to improve the representativeness of trial populations.

Underserved groups remain underserved as eligibility criteria routinely exclude them from breast cancer trials

“…Common eligibility criteria clinical exclusions, as highlighted with overlap by recent FDA guidance [17,18] and those relevant to breast cancer clinical trials from the INCLUDE 2017 framework [2], as requiring revision in order to enhance clinical trial diversity, were assessed (Table 1). Examples of INCLUDE 2017 framework underserved groups deemed not suitable for inclusion in this study included ''looked after children,'' ''carers,'' ''military veterans,'' ''those in full-time employment,'' ''rare diseases,'' and ''people who do not attend regular medical appointments'' as this data was either not relevant to breast cancer trials (''looked after children'' and ''rare disease'') or this data was not captured in the patient characteristic section of the trials assessed.…”

“…Recently the New England Journal of Medicine editorial, ''Striving for Diversity in Research Studies'', highlighted this issue [4] and introduced a requirement for ''a supplementary table that provides background information on the disease, problem, or condition and the representativeness of the study group'' that must be part of all publications in the NEJM from January 1st, 2022. INCLUDE, a 2017 initiative from the UK's National Institute of Health Research (NIHR), has defined and identified underserved groups in clinical trials and accompanying barriers to recruitment [2]. Examples of underserved groups listed by this framework include the elderly (particularly those O75 years of age), ethnic minorities, the socioeconomically deprived, pregnant and lactating women, the lesbian, gay, bisexual, transgender, queer, and others (LGBTQþ) community, people living in rural areas and those with comorbidities, including disability, mental health conditions or cognitive impairment, among others [2].…”

“…INCLUDE, a 2017 initiative from the UK's National Institute of Health Research (NIHR), has defined and identified underserved groups in clinical trials and accompanying barriers to recruitment [2]. Examples of underserved groups listed by this framework include the elderly (particularly those O75 years of age), ethnic minorities, the socioeconomically deprived, pregnant and lactating women, the lesbian, gay, bisexual, transgender, queer, and others (LGBTQþ) community, people living in rural areas and those with comorbidities, including disability, mental health conditions or cognitive impairment, among others [2]. People with particular disease characteristics, such as people in cancer trials with brain metastases, have also been identified as an underserved group by this framework [2].…”

“…Examples of underserved groups listed by this framework include the elderly (particularly those O75 years of age), ethnic minorities, the socioeconomically deprived, pregnant and lactating women, the lesbian, gay, bisexual, transgender, queer, and others (LGBTQþ) community, people living in rural areas and those with comorbidities, including disability, mental health conditions or cognitive impairment, among others [2]. People with particular disease characteristics, such as people in cancer trials with brain metastases, have also been identified as an underserved group by this framework [2]. Patient recruitment continues to be a problem in clinical trials globally [1], and engaging underserved groups in trial recruitment poses additional challenges, sometimes due to the small size of these target populations but also other recognized barriers [3,5].…”

“…There have been recent calls globally to improve participation in randomized trials by groups that traditionally have been poorly represented [1e3]. These underserved groups are populations unrepresented or disengaged from medical research or services despite having a disproportionately high healthcare burden [2]. Their routine What is new?…”