Chasing the alchemy of trial diversity with a mix of culture change and practical mechanics

Health Tech founder and M&A Advisor Lloyd Price shares his thoughts with Pharmaceutical Market Europe about Clinical Trials and Diversity challenges.

"Price sees a well of digital approaches that could energise trial enrolment among under-represented communities and boost retention.

But he cautions: “It’s important to remember that technology is a tool, and its success hinges on its implementation alongside culturally sensitive practices and a genuine commitment to diversity within the research community. 

By making trials more accessible, culturally sensitive and transparent, technology can pave the way for more inclusive research and ultimately, better healthcare outcomes for everyone. 

‘Results from a poll of 2,000 people reveal respondents have significant trust in vaccines and prescription drugs but less trust in pharma companies’

Overall, technology has the potential to revolutionise clinical trial design and recruitment, leading to more diverse participation and ultimately, fairer and more generalisable medical research.”

Original Source: https://pmlive.com/pme/#/reader/51629/258023

Author: Danny Buckland, a journalist specialising in the healthcare industry

It will take a modern alchemy to ensure the recent huge advances in science are translated into better prospects for patients around the globe as, despite life-changing potential, clinical trials struggle to escape their tainted past.

Influential voices are now clamouring for cultural, conceptual and mechanical components to be blended in a furnace of intent to create a precious alloy that can deliver new therapies to broader and more relevant audiences.

New clinical intelligence and understanding are propelling a marked increase in clinical trials this year – passing the 500,000 mark in April globally – yet many will fall short because they target a narrow band of patients selected, or more critically, available for their clinical trials.

A lack of diversity is not just an economic misfire, it has become societally unacceptable and is now laden with the jeopardy of brand alienation that stretches way beyond niche condition areas and minorities.

Multiple research papers have demonstrated the inclusion deficits across ethnicity, and the continuing exclusion of women is increasingly viewed as perverse. Somer Baburek, CEO of Hera Biotech, which directs medical advances to address unmet needs in women’s health, wrote in the Clinical Leader: “I haven’t seen a lot of behaviour change on the industry side.

When drafting clinical trial protocols there are still ‘standard’ inclusion/exclusion criteria that disqualify women for critical research trials. The result?  Every woman is operating in a healthcare system that fundamentally wasn’t designed for or by women, and a vast majority of interventions and the data about their efficacy are based solely on response in male bodies.

“This is the equivalent of being forced to shop in the men’s department and the only modification you can make is the size.”

Mark Evans, Managing Director of Faze, the clinical trials business of leading healthcare communications agency Havas Lynx, comments: “This is fundamental and flawed. We have a real issue with the representation of women in industry-sponsored early-phase trials, with females accounting for 29-34% of participants due to fertility concerns and barriers such as childcare and inflexibility.

“But one research paper showed that, although only 5% of minority groups join a trial, 80% revealed that they would join when told about it. There is a willingness out there, but there is obviously a lot of historic mistrust that needs to be dealt with.”

Tackling misconceptions

Trust is a word that percolates through most discussions and analysis of the state of clinical trials. Its absence was evident in the COVID-19 pandemic when communities were reticent to respond to the vaccine, but it appears to be a learning that is struggling to embed in the pharma psyche.

Evans is positive though that an approach that blends transparency and clear communication can turn the dial.

“There is a basic misconception about what a clinical trial is,” he says. “Awareness of the different types of clinical trials is a key issue. Say the words ‘clinical trial’ and most people will think about a phase 1, paid, healthy volunteer trial. They do not realise and have not been told that in later stage trials, treatments have been carefully researched and there is more knowledge about their efficacy and side effects. We have to improve understanding through better health literacy.

“The standard communication approach taken in the industry is a standard one-size fits all approach. Ensuring we target our underserved communities is pivotal to ensuring we are reaching our audiences and being inclusive in recruitment. It is always our recommendation to our clients to ensure they are tailoring their approach to suit the market and audience in which they are trying to recruit.

Faze specialises in finding, engaging and empowering clinical trial patients and, along with their partner Republica Havas Health, a prominent multicultural agency in the US, have proven capabilities for engaging underrepresented groups. Vanessa Bolanos, Managing Director at Republica adds: “Cultural cues and insights, layered with deep-rooted data, ensure we are communicating with patients and/or caregivers in a way that is empowering, increases trust and allows for deep connections. Additionally, we use our proprietary auditing dashboard powered by culturally driven key performance indicators to help determine opportunities to improve cultural fluency and representation.”

“Consumer brands like Adidas seek to understand their audiences and design experiences around the communities they serve. As an example, Adidas partnered with Havas Middle East to create a movement that encouraged women in MENA to see water as a liberating space, through a bold activation on a beach. Built on the insight that only 12% of women in the UAE are comfortable wearing a swimsuit at a public beach, Adidas wanted to reinforce inclusivity in swimming with the launch of its first full-cover swimwear collection.

Within a week, the billboard started a global conversation, reached 350 million people and 36% of women now feel comfortable vs. the inital 12%.

“This type of sophisticated consumer marketing could bring new levels of connection to clinical trials.”

Regulations introduced by the FDA, and new rules inbound from the EMA, are adding degrees of compulsion but Evans believes industry should adopt diversity in clinical trials as a core element rather than as a tick-box exercise. “It can’t just be a tick-box exercise as, at some point, it becomes a commercial consideration and if someone in the room cannot articulate the value then diversity is at risk of being deprioritised.

“We need to be creative, to learn and to measure the effectiveness of our diversity strategies. Promisingly, there is a genuine mission to deeply understand patients which I believe will accelerate and drive health equity over the coming years.”

Enshrining diversity

Matthew Hunt, CEO and co-founder of 11 London, the creative healthcare agency that has a 50-50 split of clients from pharma and patient groups, believes the threads that can drive equitable and accessible trials need gathering together to promote progress.

“There has not been a joined-up narrative between diversity and commercial considerations,” he says. “People don’t always know where to go to recruit from different audiences, especially if they’re used to using the same recruitment methods, the same recruitment agencies, the same recruitment pools in the same geographical areas. Unless there are financial or regulatory imperatives then I fear there will be debate and fight in the margins of diversity.

“New regulations are welcome but they too could be tinkering at the edges. They could well mandate improved racial diversity but diversity is much more than that. There are societal aspects that are often overlooked: different occupations, socio-economic, culture differences and the fact that clinical trials mainly take place at big teaching hospitals.”

Matthew advocates for a radical recalibration of how clinical trials are designed, communicated, enrolled and logistically supported. “We need to do this and show that by enshrining diversity we can achieve better long-term financial results. It may involve initial costs but our belief is that you will have fewer dropouts and reach the endpoints and more to enjoy greater success if diversity is at the heart of the trial design,” he observes.

11 London, which operates on a health and humanity mantra, has polled and researched communities to get a deeper appreciation of the factors that divide, and unite, people across gender, race and financial metrics. The results from the poll, conducted by More In Common among 2,000 people, are revealing with respondents expressing significant trust in vaccines and prescription drugs but less trust in pharma companies.

Building trust

Significantly, the poll showed that 92% of the public are familiar with clinical trials and 60% felt it was important that a diverse population is included in any trial. Only 30% were concerned about their safety.

“This is illuminating and gives us optimism,” adds Matthew. “But we need to develop a different mindset and accept that accessing more diverse communities might entail expenses and that they will need to be structured [so that] people who don’t live near a university hospital or who struggle to take time off work can be included. This needs to be championed from the top, not the mid-level.

“There are a lot of initiatives to make clinical trials recruitment easier and more diverse but I’m not confident we have the attitudinal shift that it really needs yet. We have to keep applying pressure and change will happen. We will see more small trials with greater retention rates and results and people will want to do that more widely. The regulatory environment will help propel us forward.

“People have the best intentions and one day diversity will be the norm. There is a great quote from Hemingway on how you go bankrupt and the answer is ‘gradually, then suddenly’. We are still working our way through gradually on diversity and are nowhere near suddenly but it will happen.”

Building trust needs to be embedded in all initiatives and particularly the increasing use of technology from wearable sensors to blockchain that make participating in trials easier and secure.

Lloyd Price, a healthcare tech entrepreneur of strategy, growth, merger and acquisition specialists Nelson Advisors, sees a well of digital approaches that could energise trial enrolment among under-represented communities and boost retention.

But he cautions: “It’s important to remember that technology is a tool, and its success hinges on its implementation alongside culturally sensitive practices and a genuine commitment to diversity within the research community. By making trials more accessible, culturally sensitive and transparent, technology can pave the way for more inclusive research and ultimately, better healthcare outcomes for everyone.

‘Results from a poll of 2,000 people reveal respondents have significant trust in vaccines and prescription drugs but less trust in pharma companies’“ Overall, technology has the potential to revolutionise clinical trial design and recruitment, leading to more diverse participation and ultimately, fairer and more generalisable medical research.”

Focus on the mechanics

Philippa Pristerà, Strategy Director at patient communications agency Cuttsy + Cuttsy, believes a focus on the mechanics of how clinical trials are designed and delivered is essential to generate real advances in diversity and inclusion. “We actually have the solutions; it is a matter of applying them,” she says. “It may need a cultural shift in mindset or some organisational change, but there are some foundational things we can do to reduce barriers to engagement – critique the eligibility criteria, review the feasibility of the protocol and, importantly, sense-check the informed consent form and process.

“We are actively working with one client to make their 40-page informed consent form (ICF) more accessible, user friendly and at least half the length. And because they run not just one trial but hundreds that all follow the same ICF template, we’re creating a modular framework and library of suitable content so these improvements can be standardised across all pipelines. It requires a concerted effort between legal and compliance, and of course patients, but it could make a huge difference to potential trial candidates who find current approaches neither informative or accessible.”

Cuttsy+Cuttsy prides itself on creating a strong backbone for clinical trial recruitment and retention by employing channel-agnostic strategies and communications that cut through the complex and has supported over 110,000 patients across more than 30 disease areas, in more than 100 studies in the last eight years alone.

“Too often, people may disengage from trials because the purpose and detail has not been explained clearly enough or because the protocol is not feasible for their personal circumstances,” says Philippa, who specialises in patient engagement. “Then, there’s the issue of mistrust, both in pharma generally but also specifically around data handling and security. Current and historic discrimination can heavily influence engagement, with concern or uncertainty about how someone’s data or samples will be used and stored being key issues for certain communities. These need to be better understood so they can be addressed appropriately.

“We believe barriers can be dismantled by providing the stepping stones, starting with improving the informed consent form, then how we can involve people in the clinical trial design and how the logistics work. We need practical steps and to not expect change to happen overnight.

“If we can provide industry with a roadmap for patient-centricity then the true value of diversity will emerge. One-off patient involvement won’t solve everything. But we need to start somewhere, and it’s OK to start small. If we follow a long-term path that aims to address key barriers overtime, then the return on investment will come. There has to be some faith that this will be worth it. But I think there is enough evidence now, enough demonstration of the need, and enough organisations that have already taken a patient-centric approach, to show that this does lead to positive change. We just to need to encourage and support others to follow that roadmap, step-by-step.”

Philippa adds: “Engaging with community leaders and champions at all stages can reveal issues that might otherwise be missed and lead to poor recruitment or poorly performing trials. There are assumptions that need to challenged such as people being reluctant to engage because they don’t want to take part when it might simply be that they don’t see the trial information, or see it as something relevant for them to read.

“There are more people in patient advocacy roles within pharma, which is brilliant, but now we need to embed the required culture change to make diversity and accessibility part of every trial at the operational level. Providing that missing practical support will help to accelerate the change we need.”

The passion and commitment to elevate diversity is growing across industry and those good intentions need to be fused with practical steps to generate meaningful, lasting change and benefit.

References are available on request.

Danny Buckland is a journalist specialising in the healthcare industry