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Recruiting patients to increase diversity & inclusion in clinical trials: one size does not fit all

More so now than ever, the inclusion of more diverse, and often more relevant, study populations is gathering momentum within the clinical trial community.

From calls for more diversity in age, gender, and ethnic groups, to more consideration for lifestyle and cultural differences, trials need to ensure they represent the key population of interest and identify a greater range of opportunities to maximise benefits for both patients and pharma.

Seth Nelson, senior director, Patient Recruitment Solutions at ICON, stresses that pharma needs to proactively encourage inclusion and diversity across clinical trials, from trial planning and protocol development to patient recruitment and education.

Effectively, the detail and the differences matter. “Across the spectrum, optimum outcomes will only be achieved by drawing on patients’ cultural, geographical and everyday influences,” he points out.

Challenges to the design, planning and implementation of clinical trials

The past 18 months of the pandemic and the respective lockdowns has had a marked impact across both healthcare and medical research. Clinical trials are no exception and have been on the receiving end of both challenges and opportunities.

The identification and recruitment of patient participants in trials became more difficult, as non-COVID patients steered clear of hospitals and GP surgeries for fear of infection and/or over-burdening an already overwhelmed NHS. On the plus side, this limited the spread of infection, but at the same time, opportunities to recruit and retain potential trial participants were also impacted.

However, he adds, that on a positive note, the pandemic created a captive audience and generated an interest and increased understanding in health and research. “Now is the time to capitalise on that to improve diversity and inclusion.”

Greater diversity and more tailored participant subgroups in clinical research

For some years, patients have had an increasingly more central role in how clinical trials are designed and conducted. Nelson notes that pharma and clinical trial organisations are listening to the patient voice and developing a protocol with the patient foremost to plans. “This is vice versa to what was done historically, where at the most basic level the sponsor identified the unmet need, proposed a potential treatment, developed a protocol based on this and then searched for potential participants,” he explains.

He believes a departure from the traditional approach to conducting trials will be truly patient-centric, leading to greater participant diversity, as well as improved education that is more tailored to the needs of the study population.  Together these will ensure patients are more engaged because the trial has greater relevance to them. “I think this is going to make a significant impact on trial success moving forward.”

Nelson explains that one of the changes in medicine overall is the move towards more personal medicine. “We’re narrowing down the overarching therapeutic area into smaller groups.” A similar approach is being adopted by including greater diversity in clinical trials, he says, explaining that there will be a higher number of subgroups, such that any potential treatments, as well as the trial process, can be made more honed to unmet treatment needs.

Oncology is typical of this approach with not only multiple different cancers, but within one cancer type, there are often many specialist subgroups. “In oncology, especially in lung cancer, there’s been a lot of advancements driving interest in new therapies. Human nature draws us to those we see provide value, so when you see success coming from something, you’re more interested in being part of it – both as a patient, trial participant and as a physician.”

Speaking to diversity beyond that of the disease aetiology alone, Nelson points out that trial planning needs to take into account a wide range of social and lifestyle factors. “We need to understand how a new therapy interacts with everybody differently,” he says. “Being able to bring a more diverse data set and understanding of how that therapy is going to impact and help a more diverse population, provides better insight on where potential success of the therapy or product lies.”

“If you aren’t including a diverse population, you’re missing a large part of what you’re really trying to do and understand,” he stresses. “It’s time to understand who this is going to benefit and how it will benefit them.”

ICON is placing diversity and inclusion central to its trial work

Diversity and inclusion are high on the list of ICON’s priorities in trial planning and implementation. Nelson notes that the design and planning process needs to shift physically and mentally to accommodate the needs of the most relevant patients. “If a disease has high prevalence in a subgroup, then take the trial to them – geographically, culturally, and educationally. Trial design needs to incorporate that patient population at the table from the word go.”

He outlines ways that ICON is adapting to meet these needs and insists that the solution is far from a one-size-fits-all approach.  “Instead of really going after just interest with outreach and social media, we’re utilising census data again, and materials that address a larger population to identify subgroups that have the greatest potential to be positively impacted by a certain treatment or study.”

“It matters who you’re identifying and reaching out to, because that changes your strategy and your outcome,” Nelson emphasises. He reflects that progress has been made but there remains a long way to go. Patient advocacy groups are being better engaged, he adds, but much more education of all stakeholders is still needed. “The status quo is starting to change and is moving in the right direction, but there are a lot of pieces in this puzzle.”

Diversity and inclusion need to be embedded in planning if the desire is to truly transform clinical trials. “We need to move on from ‘here’s a trial… now you need to identify a more diverse population’,” Nelson points out, “to something that more proactive and integrated into protocol planning, patient voice insight,  patient recruitment strategies, and patient advocacy engagement.”

And it needs to be a consideration in the selection of study sites, training and educating site study teams and investigators, and patients. “Driving the overall strategy that we’re all part of diversity and inclusion within the trial, needs to be a major focus from the start.”

Engaging patients and encouraging study participation requires a carefully considered value proposition. “It’s providing that kind of value statement of what it is about the study such that participating can hopefully change the outcome of your disease. We need to present the value proposition to patients,” says Nelson.

Essentially, trials need to be tailored to meet the real-world needs of patients with different backgrounds including ethnicity, gender, geography, lifestyle factors, and different ages, among others. “We’re really diving into that and honing into which populations these therapeutic areas impact the most. We are then creating the trial around that – sites are selected within the regions where that population lives. The site staff benefit from localised education on how to recruit, and how to get in contact with that population,” adds Nelson.

He reinforces that this is a long-term goal, and that there are no shortcuts. “We’re taking the right steps, but there’s this big turn that we need to make, and we need to make it every single time we put a study and a protocol together.”

About the interviewees

Seth Nelson

Seth Nelson has over 15 years of clinical research experience, focused on clinical operations and patient recruitment. In his current role, Seth leads Patient Recruitment & Retention Services. Prior to his current role, Seth held multiple high level positions within the clinical research space including heading a multi-site research network, VP operations in clinical research recruitment and retention. He holds a BS Biology and Chemistry and a MS in Medical Physics.

About ICON

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ICON is a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. ICON’s focuses on the factors that are critical to clients – reducing time to market, reducing cost and increasing quality – and its global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards. With headquarters in Dublin, Ireland, ICON employs approximately 15,250 employees in 94 locations in 40 countries. Further information is available at www.iconplc.com.

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