Eight routes to patient diversity

Norstella helps clients achieve diversity in clinical trials while committing to it in its own practices. Andrew Warmington, manufacturing editor at Norstella, spoke to Fenwick Eckhardt, senior manager of clinical new product development at Norstella

Diversity is a widely used term in many contexts and clinical trials are no exception. But what does the word actually mean in the context of clinical trials? Fenwick Eckhardt, senior manager of clinical new product development at Norstella, says that it is first and last about “being as inclusive as possible”.

The pharmaceutical industry is well aware that it needs to diversify its patient base. That said, the challenges involved are extremely complicated.

What are the indicators?

Race, ethnicity, gender, and age are good starting points, Eckhardt says, because a lot of data is captured around these markers, which helps create an actionable data point when planning for diversity in trials. However, there are many other factors organizers should consider when they recruit trial participants.

“One is income,” Eckhardt says. “Do people have the means to participate if it means missing a day or two of work or having to pay for childcare? Also access to transportation and proximity to the site trial. Do they have the means to even get to the site? Education level and language can matter if you’re asking them to read instructions. And if you have a population who really don’t have access to healthcare, how are they going to learn about a clinical trial opportunity at all?”
Of course, given the near-infinite variety of human lived experience, it is impossible for a clinical trial to replicate more than a fraction of the variables. So how diverse is diverse enough?

There is no easy answer to that, but Norstella has seen many clients start by looking at the epidemiology of the disease itself, including whether it tends to impact people more of a certain race, ethnicity, or age group. Thus, at a minimum, companies can try to ensure that the distribution of patients should reflect the population impacted by the disease.

Areas of focus

Eckhardt identifies eight areas in which pharma companies are working to embrace diversity in clinical trials. In each, she identifies a sliding scale from basic to best practice:

• Data sources & collection: Some clients still rely on Google, while the most advanced are accessing cutting-edge proprietary data and areal-world data to make decisions around diversity in their clinical trials.

• Protocol design: Some just copy and paste their old plans into new clinical trial, while the best look carefully at the eligibility criteria for that trial to understand the impact it has on a patient population. For example, a trial may exclude patients with a history of diabetes, but the effects of that on the diversity of the patients should also be considered.

• Clinical trial feasibility: It is important to prioritize sites working with high concentrations of diverse patients. That includes targeting diverse investigators, given that patients generally like to see doctors who look like them and speak the same language.

• Site engagement and community engagement: Sponsors should work with both sites and communities to make diversity recruitment and enrolment a priority via a partnership approach, not just telling them to increase their diversity quota.

• Patient engagement: This means finding new ways to reach diverse patients in a meaningful way and give them the resources that they need to participate in clinical trials.

• Clinical trial disclosure: Companies need to report the percentage of diverse patients that were enrolled, something that many still do not do very well.

• Organizational commitment: Some companies have public commitments from the C-Suite to making diversity in clinical trials is a priority, and cascade this down into individual goals, team goals, and bonus structures such that it becomes part of what they do every day, and they are measured against that. For others, it is still little more than a buzzword.

Pharma megatrends tie in

Greater diversity in clinical trials also ties in with other major ongoing trends, most obviously decentralized trial design. The term has perhaps become a cliché but its ethos, to reach patients where they are, giving them opportunities to participate in telemedicine or mobile health, clearly makes it easier for historically underrepresented groups to take part in trials.

The same is true of personalized medicine. It is well known that very many drugs work better on certain ethnic groups than others. “If your clinical trial is not diverse, you will never uncover like potential for personalized medicine,” says Eckhardt. “You’re leaving innovation for patients on the table.” Likewise, the use of real-world data and artificial intelligence (AI) will not reach their full potential if they are running algorithms over data sets that only include white populations.

How Norstella helps

There is much work to be done on data collection and Citeline assists its clients with clinical trial diversity data via Sitetrove Global Patient Insights. This is a line extension to Sitetrove, in which Citeline has introduced information about global patient populations to help clients understand the patient landscape and select sites and investigators with access to the right patient populations.

The dataset has strong coverage in the US, where patient diversity information is less restricted by GDPR, but there is also patient population information from 20 other countries. Clients can tap into this resource to assist with their feasibility and patient engagement planning and take diversity, patient populations, and their needs into consideration when planning their trials.

Also on the patient engagement front, Citeline Connect helps to recruit and enrol patients into clinical trials. Citeline uses its real-world data to fuel that work and has partners in its patient recruitment marketplace who specialize in reaching different communities. Finally, through TrialScope Disclose and some other data products and services, Citeline can also assist with reporting and actually help clients be transparent with their clinical trial results, including demographic reporting.

Regulation drivers

Regulation, particularly the guidance issued by the US Food & Drug Administration (FDA) in 2023 is also becoming increasingly stringent around patient diversity.

“It’s very clear that this is a huge priority for the FDA and health authorities,” Eckhardt says. “They’re in the process of figuring out how can they make this a mandate, and, in some cases, they are starting to take action, for instance by not approving clinical trial plans that fail to include diverse populations or by requiring post-marketing surveillance.”

The pharma industry is responding by including diversity in all of its plans for trials as the pace of regulation quickens. Schwalje believes that there will soon be a mandate for all demographic data to be reported in clinical trials and for transparency to be included when submitting clinical trial results.

Norstella’s own commitment

Norstella has demonstrated its commitment to diversity, equity, inclusion, and also belonging (DEI&B) in multiple ways. It has launched a global DEI&B committee that is governed by colleagues and sponsored executively across the five brands of Norstella and globally. This committee is dedicated to action, awareness, and building an inclusive community representative of the global colleague base. DEI&B is now included in compliance training.

The committee has developed two mission statements to demonstrate commitment to our colleagues and our commitment to health equity:

• DEI&B committee mission statement: ‘The committee aspires to create a sustainable culture that embeds our values. Our mission of smoothing the path to life-saving therapies is infused in all we do, through strategic initiatives and partnerships, stewardship and education, this committee will help shape Norstella’s future as one where all employees are heard and respected, can fully realize their potential and feel empowered.’

• Commitment to health equity: ‘As a member of the life sciences industry, we are committed to ensuring health equity, on multiple levels. For our employees, we offer comprehensive health benefits. For our clients and partners, we seek to collaborate with organizations whose policies and operations reflect health equity. For patients, we work tirelessly to promote diversity in medical research and educate the public to make informed decisions. And for the industry, we strive to make the health system work better for everyone.’