The inspirational quote ‘It takes all of us’ has reverberated through social justice and become a sporting mantra, hailing the benefit of combined effort for a greater good. Its inclusivity is at the core of transformative performances on sporting fields and step changes in attitude and approach in society.

Its value in health could be immeasurable in tackling disparities that manifest in reduced access to anything from screening and diagnostics to the latest therapies and care, and varying levels of life expectancy influenced by geography income, education, ethnicity and employment status.

Distilling ‘It takes all of us’ into policy and procedure is a Herculean task but energy and resources are now being directed towards a rich patient-centred focus on R&D, clinical trials and access that go beyond the ambition and reach of ‘patient-centricity’ to open up more dynamic opportunities for collaborations and targeted care.

The challenge is huge: ethnic minorities and women are vastly under-represented in clinical trials despite healthcare provision and research showing a clear link between certain patient populations and lower health outcomes.

Innovation and effort are being channelled into righting this wrong through deeper engagement with patient groups, reformulation of regulation and pharmaceutical companies committing to increasing their reach.

“You can’t fully serve a patient community or provide access to medicines to all people when they need them, if you’re not being inclusive in your approach right the way through the pipeline and the entire product life cycle,” says Helen Laurence, Senior Vice President at Precision AQ, an agency that integrates data, evidence and market insights to widen patient access and care. “Empowering access to medicine is a high-level mission for an organisation; one that – from an ethical, scientific and economic perspective – should be built on inclusivity.

“Engaging with different types of patients in their own communities, getting insights up front and using them in study protocols is clearly going to take longer so I understand why, in the earlier stages of clinical development, pharma companies may
not feel able to make that commitment.

‘Inclusivity means starting at ‘Day Zero’ and involving everyone along the product and patient journey’

However, this can be a false economy if companies are then required by regulators to do additional trials post-approval. With AI, there is also the opportunity to explore more cost-effective options to ensure trial materials are more suited to varied patient populations.”

Recruitment and retention in clinical trials, with or without a diversity lens, is a complex and fractured environment and, despite good intentions around industry, it will take more than well-meaning internal memos to create change. The implications on under-served communities are alarming and, for an industry capable of searing medical innovation, applied problem-solving and scientific questing, the fact that so many people are not even considered for clinical trials is a confounding stain on its reputation.

Precision AQ, a group of experts and advisors working under the banner ‘Where Science Meets Humanity’, has a full-spectrum approach to unlocking access to life-changing medicines. Helen Laurence, its Managing Director, International Agencies, believes that culture change within organisations is needed to elevate diversity to act as a catalyst to both improve patient outcomes and underpin business performance.

“We should be thinking about the barriers people face, whether that’s socio-economic or disability related, and really approach it from the patient side as well as the clinical or scientific perspective,” she says. “We should have that thought process across the entire patient journey and be willing to factor in engagement with under-represented communities as part of our planning.

“There are all sorts of challenges in this. There is distrust in authorities, the pharmaceutical industry and there is debate about how different people define diversity. But unless we look at this from a patient’s view and appreciate their lived experience, we will not be able to create change.

“Encouragingly, we’ve seen a lot more focus on this from our clients, who are building diversity and inclusion into their clinical trials and beyond, and they are thinking more about their internal structures and making sure that there’s an even playing field within their organisations – so that the people making the decisions are from a range of backgrounds. It takes time, it takes investment but it is worth it. This is not just a box-ticking exercise. It is a practical way forward with multiple benefits.”

Precision AQ is aligning closely with its global R&D partner company, Precision for Medicine, working to bring patient advocacy to the heart of its projects from product development and clinical trials to commercialisation and communication to help drive enhanced performance through patient advocacy.

Helen observes: “I’m a pragmatist but there is genuine reason to be excited about the future. We have a long way to go but we are travelling in the right direction in terms of increased focus on patient insights and getting the patient voice heard. There has been a definite shift in industry and that is motivating for all of us as it demonstrates that change can be achieved and some of the terrible inequalities that have existed for too long can be levelled out or eradicated.”

Both the EMA and FDA have been ramping up the demand for organisations to enhance recruitment and participation from under-represented communities and, although the FDA push has been stalled by political change, diversity has moved on from being a note in the margins.

“Achieving equity is full of massive challenges such as funding, engagement with marginalised communities, lack of trust and historical exploitation of ethnic minorities, but my view is that diversity will be increasingly embedded in the way pharma works,” observes Jenny Carrington-Elson, Managing Director at Intent Health, a health communications consultancy with a business model designed to address health inequalities.

“Our healthcare is inherently biased, for various structural and historic reasons, and this leads to an imbalance and unfairness where the products and services that are supposed to support everyone are only really based on evidence and insight from one type of person. For instance, half the people worldwide who get HIV are women but less than 5% of them are included in trials for HIV treatments.

“So, we have products and services designed for women and other marginalised communities that haven’t actually been developed through engagement with those communities, leaving them at risk of worsening health and not being able to have the best outcomes in relation to others.”

Medical history is laced with examples of skewed judgement that seemed wise in the mists of time but somehow become engraved into everyday practice. “Look at the BMI scale. It was devised by a 19th century Belgian mathematician and based on a sample of white men yet it is still used to measure people’s weight irrespective of their sex or ethnicity – even today, people have their access to services and care based on that,” adds Jenny.

Intent Health, a company that proclaims ‘Access to healthcare is a human right’ and majors in strategic communications and collaboration partnerships, believes that co-creation with patients has to be authentic and inclusive from the first step of the product journey.

“True co-creation has to be started from day zero, it cannot be added down the line. We also have to leave our assumptions at the door and ask the community questions to discover what they want and need, and from that we develop a shared objective based on their experiences,” adds Jenny. “If we are seeking to change behaviours then time is needed to build trust so they can be fully part of projects, not just be asked what they think of a marketing photograph or leaflet.

“Constantly challenging assumptions is a critical part of inclusivity. We need to include more people with lived experience across this work. Some good projects end up being poorly executed because they fail to see or address the barriers. This relates to not making assumptions – you can’t do anything meaningful for a community without really involving them in the design and development of projects and trials and making sure their voice and influence remain at the heart of everything.”

She cites an Intent Health/NHS collaboration with Jewish communities that have a distrust of healthcare services. They created a panel of five people from the community to “advise us all the way through, challenge us, catch us out on cultural assumptions and make sure that what we’re saying when we engage the community was authentic and relevant,” adds Jenny. “The NHS allowed us two years, with the first being principally engaging with the community and building trust, and we are very proud of the collaboration because it was genuinely driven by the community, and the resulting materials and guidance were picked up by NHS England and other bodies.”

She comments: “Improving health equity can appear complex but, when resourced and with time, it can make a real difference to patient outcomes, healthcare efficiencies and business returns. Companies are naturally hesitant so we all have to make the value proposition more obvious and demonstrate how the value flows through when you widen opportunities for people, broadening access. We have to show that when organisations invest more at clinical trial stage, it translates further along the road into greater economic and health outcomes.

“I don’t think industry has quite cracked that yet but there is a lot of brilliant innovation and intention that, given time to build, will reshape the potential for communities that have missed out for generations.”

Addressing and improving diversity in clinical trials and beyond is a fundamental issue facing industry and the solutions must be all-encompassing. Jennifer Neibert, Director, Site Engagement and Medical Affairs Training with IQVIA Medical Communications believes that training investigators and research staff provides a vital uplift to remove bias and assumptions.

She agrees that while the need for inclusivity and diversity is understood, the prioritisation of action can get lost amid the noise and hierarchy dynamics of an organisation where each department is making compelling demands for attention and funding.

“The resources given are not always enough to make diversity-focused projects a reality and we frequently receive pushback on additional investments for training. We know what we are up against in terms of showing the value and importance,” says Jennifer, an experienced medical affairs and training professional. “We are on the cusp of immense impact and maybe industry is not always the fastest to adapt and change, which is a huge irony considering its main aim of pursuing cutting-edge science and innovating ways for improving patient outcomes.”

‘We are at an inflexion point of seeing this incredible change that would eradicate some of the historical barriers to equality of access in healthcare’

IQVIA, a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, is driven by a belief that diversity, inclusion and belonging ‘empower our mission to accelerate innovation for a healthier world’.

It has developed an award-winning Clinical Trial Diversity & Inclusion Site Training Toolkit that enhances research and clinical trial staff understanding of the challenges participants, providers and site staff face with diversity and inclusion and provides actionable steps to engage with, recruit and retain a diverse study population.

“The feedback has been overwhelmingly positive. Despite headwinds that come with any kind of change initiative, our site training approach to diversity and inclusion is effective and much needed, as it is based on patient insights and data, not broad assumptions,” adds Jennifer. “The toolkit helps clinical trial site staff develop better awareness and empathy, which are crucial elements in conducting effective trials with strong retention. We provide site staff with practical job aids such as conversation guides to boost understanding and collaboration with trial participants and, therefore, improve overall study success rates.”

No matter how effective training programmes are, they still have to compete in fast-paced environments where there is little opportunity to carve out clear time for seminars and lectures. Selecting the right channel, the right time and the perfect pitch that link physicians and research staff to product cycle landmarks are also emerging skill sets.

But, despite the internal resources barriers and slow pace of pharma change, the evidence of improved enrolment and retention will generate the critical evidence for greater acceptance and funding.

“At IQVIA we’re getting a lot of really good traction and feedback, especially on a couple of stand-out global infectious disease studies where we were able to help exceed recruitment targets for specific sub-demographic groups,” adds Jennifer, who is based in Raleigh, North Carolina, US. “On a global recruitment campaign for an RSV study in a population aged over 65, we worked in partnership with our patient recruitment team to provide resources and train site staff on a complex and ambitious study. The training was part of a wider effort that helped exceed recruitment goals and shows that positive, practical steps are effective.

“I am optimistic about the future, which is on full display in the partnerships we have with pharma companies that also have internal training initiatives focused on the awareness, ethos and values required to build an organisational culture that prioritises and celebrates diversity.

“Recent political manoeuvres have not been particularly helpful but they do nothing to deter our vision and ambition. We now have very clear ways that IQVIA can support diversity action planning for trials operationally. We deliver diversity and inclusion training to staff internally, and we have effective models to train clinical research sites.

“We are at an inflexion point of seeing this incredible change that would eradicate some of the historical barriers to equality of access in healthcare. There is a definite pull from our partners in pharma and even though the rate of change may be slow, I am optimistic it will continue and grow.”

That optimism is tangible, but it will take prolonged, widespread commitment from all sectors of industry to recalibrate attitudes, approaches and ambition to realise the transformative potential of diversity and inclusion.