Paving the way for representation in clinical trials
‘The benefits of including DE&I in science are far-reaching and applicable to both the clinical and patient communities alike’
Diversity, equity and inclusion (DE&I) is a fundamental requirement in many sectors of the modern world and clinical research is no exception. The benefits of including DE&I in science are far-reaching and applicable to both the clinical and patient communities alike. When embedded in scientific research, DE&I can expand our ability to revolutionise and increase access to innovations.
DE&I is a clear priority throughout Janssen. As part of the Johnson & Johnson family of companies, the values that guide our decision-making are embedded in our credo, which acts as a moral compass for all our colleagues. DE&I is not only a pillar supporting our credo, it has featured prominently for us both.
Lee-Ann Farrell comments: “I’m committed to championing all DE&I efforts throughout Janssen. I was extremely proud to represent the UK at our inaugural Janssen EMEA Open&Out Summit, which brought together open-minded colleagues who are out to make a difference in the workplace. Beyond Janssen, during my time as Chair of ABPI Wales 2019–2021, our DE&I focus included sponsoring the Womenspire Woman in STEM award and the work of Chwarae Teg, who help to ensure that women in Wales can enter the workplace, develop their skills and build rewarding careers.”
Mohamed Lockhat notes: “At Janssen, it is everyone’s responsibility to champion DE&I – I consciously recognise and value everyone’s unique needs, experiences and perspectives and encourage my team to do the same daily. This is inspired and driven by a personal commitment stemming from growing up in South Africa as part of an ethnic minority.” Despite all we have done to champion DE&I in our personal and professional lives, there are some areas, such as clinical trials, where further conversations and change are still required.
‘Diversity, equity and inclusion is a fundamental requirement in many sectors of the modern world and clinical research is no exception’
Participation in clinical trials from a range of populations is extremely important as this is how we demonstrate that medicines are effective and acceptably safe in their intended populations. Without balanced representation, including demographics, access to healthcare and standards of care, it can become difficult for the pharmaceutical and healthcare industries to have a thorough understanding of disease progression and likely drug response in different groups, which is particularly important in historically under-represented and understudied populations.
Limited representation can also contribute to a lack of trust in the healthcare and pharmaceutical industries. We’ve seen the impact from lack of trust during the COVID-19 pandemic – in the UK, data from the Office of National Statistics shows that, while vaccine hesitancy has reduced over time, rates remain substantially higher in several marginalised communities.
Muslim and black British populations are seen to be at least 3.5 times more likely to be hesitant to receive a COVID-19 vaccine (14% and 21%, respectively) compared to the white British population (4%). This is particularly worrying when people, especially men, from black ethnic groups are over three times more likely to die from COVID-19 than people from white ethnic groups, even when accounting for age, sex, deprivation and region. A similar reduction in vaccine acceptance is also seen in pregnant women, partially due to lack of inclusion in clinical trials.
For us to tackle this divide in trust and vaccine hesitancy, we must ensure clinical research is more representative and inclusive, ultimately bringing these communities with us on the scientific journey. With this in mind, we are proud to be proactively advancing representation within our clinical trials across the globe. Our ‘diversity and in clinical trials’ initiative has been in place since 2019 and focuses on three main commitments: establishing a culture, increasing access, and increasing awareness and trust within underserved and under-represented communities.
Firstly, we are dedicated to further embedding DE&I within our culture by advancing internal awareness on the need to ensure diversity in our clinical trials, as well as applying new tools to increase enrolment across diverse populations. Secondly, we are increasing access to our clinical trials through internal and external initiatives that address enrolment barriers. Lastly, we are improving awareness and education about clinical trials and the pharmaceutical industry to facilitate greater trust and enrolment among target populations.
At Janssen, we are taking steps to ensure diverse populations are represented in the countries where we conduct clinical trials and the epidemiology of the diseases. Within our global trials, we have endeavoured to focus on minority groups in countries with predominantly white majorities, in the case of the US on African, Asian and Hispanic/Latinx communities. However, we must ensure our activities encompass all aspects of DE&I, not just race and ethnicity. Some other of our initiatives include:
Intentional clinical trial site selection, improving enrolment of under-represented communities and removing access-related barriers
Incorporating flexibility in our clinical trial designs and adopting digital tools, thus reducing the burden on participants
Ensuring the availability of translators or healthcare professionals of similar backgrounds who can work closely with participants
Working with patient advocacy groups to better explain clinical research and pharmaceutical companies’ involvement, and provide culturally relevant and linguistically appropriate materials
Supporting local communities and community leaders, encouraging engagement and participation
‘When looking at the global picture, we can immediately see the potential benefit of increased representation in clinical trials’
These initiatives have already been implemented by several teams across Janssen, especially where diseases disproportionately impact specific demographics, including our HIV trials focusing on men who have sex with men, and black African men and women, as both groups are at higher risk of contracting HIV.
When looking at the global picture, we can immediately see the potential benefit of increased representation in clinical trials. In countries such as Mohamed’s home of South Africa, only 55% of the public fully accept vaccinations. We know there are significant differences in vaccine hesitancy across different socio-economic variables and demographics, where increased representation in clinical trials will be vital to regain trust in healthcare interventions.
It is also important to explore ways to better generate evidence in pregnant women and breastfeeding mothers as this constitutes a large but underserved group. It is our hope that, with greater representation in clinical trials, we can improve the health and well-being of everyone.
References are available on request. This article has been commissioned by, and developed by, Janssen-Cilag Ltd.
Article first published in PMLive.
Date of Preparation: March 2022 | Item Code: CP-305297