Diversity in Clinical Trials: The Power of Technology

Diversity remains a key issue for the clinical research sector, and it was an important topic of conversation at NEXT London this year. It’s now well-established that diversity in clinical trials is of paramount importance when determining the efficacy and safety of a treatment for the patient population as different patients respond differently to treatments. It’s vital for researchers to understand the impact of treatments and medical devices on all patients; when trials populations don’t reflect real-world demographics, it can produce misleading conclusions that differ from the real-world implications they could have. So what can be done to address these issues and make sure trials recruit the most diverse patient populations possible?

New technologies are starting to offer solutions to trial organizers that support representation within clinical studies. During this year’s conference, Alicia Staley, VP of Patient Experience, highlighted the diversity programme at Medidata which brings together products and services to widen participation in clinical trials—also noting the importance of data in improving processes to increase diversity. For example, data-driven site selection can make sure that sponsors are using sites with a demonstrated ability to enroll diverse patients, maintain accessibility, and engage patients in all trial stages. It’s also critical to keep a focus on patient-centricity, and Rachel Horovitz, VP of Product Strategy of Medidata, highlighted the need to “infuse [trial] protocol with patient voices” to increase diversity. Combining patient insights with technology that enhances accessibility may help attract broader patient pools.

Horovitz pointed out that, alongside legislation in the US to mandate diversity action plans, the US FDA has released guidance on decentralized trials “with the hopes of also using those capabilities to increase diversity in clinical trials.” Decentralization can reduce travel time and cost and make it much easier for patients with caregiving responsibilities to participate in trials, therefore supporting more diverse populations. AI may also start to play an increasingly important role in this process. The use of generative AI to create synthetic patients to increase sample sizes was discussed by Medidata’s Tanmay Jain at NEXT, as he highlighted the potential of this technology to ensure trial populations are more diverse, explaining how synthetic data can be used to “upsample” patients from certain backgrounds.

Diversity in clinical research extends beyond trial populations, and widening access can occur at all stages of the clinical trial lifecycle, including by making sure that everyone has access to certain technologies. iheed’s Kunal Patel reminded audiences at NEXT that access to tech and tech literacy is not equal, as some people do not have the same opportunities to develop the required experience and skills. This is an important issue to address to ensure equal access. Similarly, Rachel Horovitz underlined the importance of diversity across research teams as a “lack of clinical investigators that are actually representative of the patients they want to treat” can itself be a barrier to greater diversity within patient populations.

As the industry continues to reflect on clinical trial diversity and ensuring access to research is equal, innovation and technology are playing a significant role. The suite of tech solutions that were discussed across NEXT this year—in particular, AI and decentralization tools—are beginning to make trial participation easier for many patients who may have previously been excluded by reducing the burden of taking part in research.

In Summary: An Exciting Future for Clinical Trials

Medidata’s NEXT London was a valuable opportunity to hear insights and experiences from experts across the industry. We were delighted to welcome so many life-sciences leaders and professionals, and we are already looking forward to maintaining the momentum at NEXT Basel in May. The clinical research sector continues to move at an incredible pace and it was great to see how new technologies, including wearable sensors for patients and generative AI, are being implemented across the industry.