Dr. Janet Valentine, executive director of innovation and research policy at the ABPI, during a session at the NICE conference 2023. Image credit: Abigail Beaney

Real-word data (RWD) is proving to be a beneficial way of including data from more underrepresented populations in the drug approval processes.

Discussions at the ongoing National Institute for Health and Care Excellence (NICE) conference 2023 in Manchester highlighted how RWD is being used to show the benefits and risk to patients from diverse backgrounds who are generally under-represented in clinical trials.

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During a talk at the conference, Dr Janet Valentine, executive director, innovation and research policy, Association of the British Pharmaceutical Industry (ABPI), spoke about the NHS Galleri trial and how RWD has improved diversity.

“What the NHS has done here is they’ve been able to enrich the patient populations who are usually underrepresented in clinical trials and they have been very successful in doing so,” Valentine said.

Valentine added that the building of public trust will be absolutely essential to underpin the use of RWD. Diverse populations remain underrepresented in clinical trials in the UK, mostly due to mistrust in healthcare, something which experts expect will take time to improve.

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Earlier this year, the Health Research Authority (HRA) published guidance about improving diversity in clinical research, which included a number of steps to improve diversity in clinical trials.

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“What we can see in the data through enrichment is that the NHS has been able to achieve the diversity they want across age groups and across deprivation, however, less so with ethnicity, and the reason for this is because ethnicity is still poorly recorded in electronic patient records.”

RWD is data based on patient health, experience or care delivery collected outside of clinical trials. It stems from a variety of sources including health records, registries, surveys and observational studies.

Following the release of the NICE real-world evidence framework, NICE is using RWD as part of their advisory panel discussions in a variety of ways including assessment of applicability of clinical trials to patients in the NHS.

According to a GlobalData report from 2021, the greatest increase in clinical trials measuring real-world evidence (RWE) occurred from 2016 to 2019, with the number of studies rising each consecutive year, from 76 trials in 2016 to 162 trials in 2019.

GlobalData is the parent company of Clinical Trials Arena.