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Tackling trial diversity in a biased clinical development landscape

Against a backdrop of increasing clinical trial complexity, tackling participant diversity was a key area of discussion at this year’s Clinical Trials in Oncology West Coast (CTOWC) 2024 conference.

Experts from the pharmaceutical and biotech sector came together at CTOWC in Burlingame, US, from 22 to 23 April, to explore the issue of diversity and what needs to be considered to improve representation.

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Overwhelming evidence suggests a skewed population participating in clinical trials. “There is much more work required to better monitor, and improve random control trial participant diversity,” said the UK’s National Institute for Care and Research (NIHR) whilst publishing a report in 2022

Among other findings based on age and sex, the NIHR found that 86% of RCT participants were white from 2019 to 2021. A recent study published in the British Medical Journal (BMJ) stated that acute care trials in leading medical journals rarely included sex and gender-based analysis.

“The entire system of clinical development is biased [in terms of patient diversity]. It’s difficult to change that dynamic, but it is happening slowly,” said Oscar Segurado, ASC Therapeutics’ chief medical officer, in a session at CTOWC.

The lack of diversity in trials not only presents scientific issues but ethical ones too. The notion that some treatments have only been tested – and thus might only be effective – in some disease populations is concerning. But in its two-fold consequences, underrepresentation means that some patients do not have access to promising – and potentially life-changing – therapies.

Changes are occurring, catalysed in part by action from regulatory agencies. The US Food and Drug Administration (FDA), for example, is currently working on new guidance that outlines how companies must ensure diversity in clinical trial research.

Cecilia Tran-Muchowski, ProfoundBio’s head of clinical operations, said: “Even though the guidelines are not finalised, it’s important [for the pharma industry] to look at.”

Speakers at the conference placed importance on “intentional effort” by sponsors of trials.

From a sponsor’s point of view, measuring that success in clinical data demonstrates that you support [FDA guidance], Tran-Muchowski said.

Indeed, sponsor actions will be critical going forward as treatments become more nuanced against a landscape of rising cancer prevalence across all demographics. The push for diversity, equity, and inclusion (DEI) has become a pivotal focus of legislation not just by the FDA, but by other global regulators too. Going forward, clinical data from trials will need to demonstrate a drug or biologics’ safety and effectiveness in multiple subgroups.

“Ultimately when a drug is approved, we want the drug to have the biggest number of patients available to it,” Segurado added.

Strategies for improvement

In a session specifically focusing on strategies to tackle the historical lack of diversity in clinical trials, experts from Genentech said that there is no blanket to the issue.

“We took many different approaches and adjusted along the way,” said Patricia Mader, executive director of US Medical Affairs and head of Evidence Generations Oncology, while recounting their experience in addressing diversity in trials.

Genentech’s Tania Szado and Patricia Mader at the Clinical Trials In Oncology West Coast 2024 conference in San Francisco held from 23 April to 24 April. Image credit: Arena International/GlobalData.

Technology, undoubtedly, has the power to address many of the inherent issues of lack of participation from underrepresented groups. Web-based eConsent, social media, remote patient monitoring (RPM), and wearables can all increase the accessibility to clinical trials. Decentralised clinical trials (DCTs) are also playing an increasingly important role in trial enrollment.

However, Tania Szado, principal oncology medical science director, US Medical Affairs, Scientific Collaborations & Alliances at Genentech, remarked that technology does not always work.

“Not a single person used our electronic consent forms,” Szado said about a particular Genentech trial. “Technology was not able to replace patient-physician discussions and a tangible piece of paper.”

Providing something as simple as transport for patients to and from cancer trial sites is a robust approach, on the other hand.

“Transportation support is a no-brainer. It is something we should do in all our trials. Removing those kind of barriers [is important],” Szado added.

Patient advocacy groups too have become an integral cog in the clinical trial experience.  These organisations act as critical supporters of the patient. As such, they are an important mediator in how an individual experiences a clinical trial and, ultimately, how trust is developed between patients and clinical healthcare systems.

Big pharma companies are vocal in how they are supporting patients and addressing challenges. Pfizer, for example, states it works with hundreds of patient advocacy groups across North America, Europe, South America, Africa, and Asia. GSK, too, works with patient organisations from many therapeutic areas beyond those aligned with the company’s core disease expertise.

GlobalData analyst and chair of the event Jasminemay Barcelon highlighted the importance of patient advocacy groups to Clinical Trials Arena: “Advocacy groups give patients an avenue to gain more information and share their experiences with clinical trials they have encountered. Utilising these groups is important to increase the visibility of drug trials.”

Public trust

The success of clinical trials inherently relies on patient trust. This took a big hit across the pond in the UK recently in the wake of the Infected Blood Inquiry. Men, women, and children were administered infected blood in the 1970s and 1980s as part of clinical trials.

The NHS Health Research Authority stated: “Our role is to ensure that clinical trials carried out in the UK are safe, ethical and protect participants so that people who are invited to take part in a clinical trial can be confident to choose to do so.”

One of the points that needs addressing is diversity which, according to a recent UK poll, goes hand in hand with trust. Commissioned by YouGov, the study found that 88% of respondents believe that it is important that health and social care trials include a diverse range of participants.

On a global level, oncology trials themselves are become more diverse and complex. It remains to be seen whether the diversity of those enrolled can keep up.

“We’re going in the right direction but we’re not there yet,” Segurado remarked.

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