Be Part of Research: reimagining the current paradigm in clinical trials
Dr Esther Mukuka, NIHR Head of Equality, Diversity and Inclusion (EDI) writes about the importance of EDI in research and why clinical trials need more diversity.
COVID-19 has dispelled any myths that social and structural considerations have no place in clinical research. If anything, this pandemic surfaced underlying social and structural inequalities and how they impact people's experience of our health and social care systems. These disparities are now well known and to an extent widely accepted and unless you have been living under a rock, you should know that more than ever, there is a greater emphasis on integrating inclusive practices in healthcare innovation through clinical research. The pressing need to pay closer attention to diversity and inclusion as we seek to encourage more people to be part of the research comes with a long-term commitment to change, a review of our systems and processes, and co-production with relevant communities.
The disaster of the pandemic has already led to innovation in clinical research and has created an opportunity to address some of these inequities. NIHR data shows that a total of 1,075,000 participants have taken part in COVID-19 research, across more than 180 studies. Of these, more than 100 studies were funded by the NIHR, amounting to more than £108 million given to dedicated COVID-19 research. This was achieved by raising awareness, building trust and community partnerships. As a result of the research studies published showing that people from ethnic minority backgrounds were disproportionately being affected by COVID-19, The Be Part of Research campaign was launched and a series of high-profile people were sought and agreed to take part in the initiative. Celebrities Omid Djalili, Whoopi Goldberg and Sanjeev Bhaskar joined forces to appeal for black, Asian and minority ethnic (BAME) participants to take part in vital COVID-19 research to help establish why people from BAME populations are at greater risk from coronavirus. As more people came forward, the researchers were able to further explore why BAME communities were more at risk and to continue looking at the best treatments.
This imperative is undoubtedly a tall order for clinical researchers who want to make the step-change to be more inclusive but are stuck searching for a starting point. So, here are some practical actions for consideration to increase diversity in clinical trials.
Shifting Power: Adopting cultural competent strategies and prioritising cultural safety
Cultural competence is the ability of health providers and organisations to deliver health care services that meet the cultural, social, and religious needs of patients and their families. It recognises that disparities in healthcare stem from cultural and other barriers not only between patients and healthcare providers but also between communities and health systems. Some strategies for improving cultural competence in individuals and systems include:
- Encouraging families to participate in healthcare decision-making.
- Incorporating culture-specific values into health promotion
- Providing cultural awareness training
Cultural safety foregrounds power differentials within society, the requirement for health professionals to reflect on interpersonal power differences (their own and that of the patient), and how the transfer of power within multiple contexts can facilitate appropriate care for Indigenous people and arguably for all patients. Pursuing cultural competency, safety and humility will effectively allow us to challenge the health inequities we are seeking to overturn. Strategies for building cultural safety include:
- Building and maintaining a respectful relationship led from the perspective of the participants
- Co-designing systems and processes with your relevant groups
- Reflecting on mistakes and lessons learned and adopting a continuous development process
Crafting an Eligibility Criteria that fosters inclusion
Changing the criteria for enrollment in clinical trials to expand the study population is another practical step for inclusion. Research shows that ‘too often the requirements are selected simply because the list of exclusion criteria has become a template, carried forwards without scrutiny from one trial to the next. At the design stage, the eligibility criteria should be reexamined and modified where necessary. This mitigates against poorly designed eligibility criteria in previous trials that effectively act as a barrier to thinking and creating inclusively.
NIHR has made some progress in supporting clinical research with guidance to build diversity and inclusion. Our Race Equality Public Action Group is helping NIHR strengthen its understanding of race inequality and social care research and our INCLUDE guidance provides a roadmap suggesting intervention points to improve inclusion, examples of under-served groups, and example barriers to inclusion. We still have more work to do and we will continue to provide opportunities for innovative practices that foster inclusion and share best practice to build a robust evidence base for interventions.
Find out more information about cultural competency training for research.
Dr Esther Mukuka, NIHR Head of Equality, Diversity and Inclusion (EDI)
The views and opinions expressed in this blog are those of the authors and do not necessarily reflect those of the NIHR or the Department of Health and Social Care.