How biometrics applications are contributing to clinical trial diversity

Ensuring equitable access to medicines is a cornerstone of the commitments many pharmaceutical companies make to their customers, patients, and stakeholders – but, recently, there has been a noticeable shift in when access discussions are taking place.

Once part of regulatory or reimbursement conversations, equitable access is now starting to be considered at an earlier stage of drug development: clinical trial design.

Clinical trial design under the spotlight

The pandemic brought public attention on clinical trial design to the forefront – with commentary on trial rigour occupying mainstream discourses, as experts worked around the clock to develop and deliver solutions. At the same time, the Black Lives Matter movement become an international phenomenon as global protests helped spark collective race conversations. What came next was an explosion in how clinical trial diversity was being understood and actioned, with pledges across the industry to diversify studies – not just in the area of vaccines, but across the board, including in oncology.

This development was further underpinned by legislation in the EU and US, in the form of the European Medicines Agency’s updated Clinical Trials Regulation, the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act, and the Diversifying Investigations Via Equitable Research Studies For Everyone (DIVERSE) Trials Act, respectively, with the latter two calling on pharmaceutical and biotech companies that receive grants from the National Institutes of Health to review their strategies on increasing participant diversity in trials.

New legislation passed in the US in 2022 also made it a regulatory requirement for pharmaceutical companies to submit a Diversity Action Plan to the FDA for Phase III or other pivotal studies. The plan outlines targets for enrolling underrepresented racial and ethnic populations (based on disease data) and explains how these targets would be achieved.

Why clinical trial diversity matters

The historic challenges of ensuring trial designs reflect that the true diversity of disease populations has been well-documented and centres around institutional and systemic biases that impact patient recruitment and retention – from logistical and economic barriers associated with trial-related costs, time off work, and travel requirements, to healthcare professionals failing to ask their ethnic minority patients to participate in upcoming trials.

At its core, clinical trial diversity is about making sure trial populations reflect those patients who will use the medicines. Good science requires clinical trial diversity: it illuminates predictive pharmacogenetic markers and uncovers efficacy and safety signals, positively impacting the external validity of randomised trials and making results more applicable to policy and clinical questions. Simply put, diverse trials improve our understanding of how medicines work in different populations. As well as being good science, clinical trial diversity supports business sustainability, helping to ensure life-changing medicines reach all patients.

Approaches to drive clinical trial diversity

Increased clinical trial diversity requires a greater understanding of the populations represented and the potential challenges that may be experienced at the study and site level. Solutions including digital technologies are expanding our ability to identify and reach diverse patient populations. Encompassing collaboration between pharma and AI developers, and the application of biometrics and digital health solutions, these approaches are being leveraged to support health equity and inclusion in three main ways:

1. Optimising enrolment. Building diversity into the enrolment stage of clinical trial design is an important way to increase the representation of under-represented groups. One approach championed by AstraZeneca is a partnership with Tempus, a leader in AI and precision medicine, providing access to one of the world’s largest libraries of anonymised data. This data enables scientists to identify and provide sites in the US with information on consenting oncology patients whose disease profiles match a specific trial, helping to develop a more diverse recruitment pool. Use of large real-world datasets allows us to understand the prevalence of the disease across different patient populations and different areas of the world.

2. Reducing barriers to improve experience. AstraZeneca recently reviewed 91 clinical trial protocols for studies in oncology, respiratory, and cardiovascular disease and concluded that 74–85% of trial assessments could be successfully collected remotely, potentially reducing the number of times a patient has to physically visit the clinic by up to 40%.¹ In this way, digital health solutions, AI tools, and remote data collection technologies have the potential to improve clinical trial diversity by enabling a broader group of people to participate, with data on symptoms and vital signs subsequently collected and reported in real-time using at-home devices.

3. Informing future R&D. Improving diversity in clinical trial participation does not end when the trial is over. With patients’ consent, research teams can utilise data and human biological samples collected during trials to help inform the next wave of drug discovery, novel target identification, and research and development. Accessing samples from diverse genetic backgrounds ensures patients can be treated no matter their origins, and analysis of these samples allows us to learn more about disease biology and uncover potential therapeutic targets at a pace that may not otherwise be possible.

Thinking critically about the future of clinical trial diversity

As we, as an industry, play our part to address health inequities and eliminate discrimination from the delivery of healthcare, there remain unanswered questions about how the clinical trial diversity landscape will continue to unfold.

Part of implementing technological advancements is recognising its pitfalls and assessing where further work – through science or legislation – is needed to ensure digital health and biometric solutions solve the problem we need it to solve. One such example is whether remote monitoring through decentralised trials could adversely affect minority representation due to disparities in internet access or care support. While the Diverse Trials Act allows sponsors to provide participants with necessary technology, our ability to think critically about whether these solutions are solutions must keep pace with innovation.

Supporting the next generation of trial investigators, as AstraZeneca is doing through the National Medical Fellowship training programme on diversity in clinical trials research, is a key part of ensuring emerging investigators are equipped with the tools and support to participate in and lead clinical research teams in ways that are rooted in diversity.

Clinical trials are most successful when the participants represent the wider disease population, supporting a robust and reliable body of evidence. As an industry, we cannot claim to be equitable if we don't understand how the medicines we create work for all those who need them. When it comes to drug development, ensuring that diversity is built into every layer of how we plan and execute clinical trials is not only a crucial part of our success, but also an ethically imperative part of ensuring access equity.