Clinical research is entering a new era: advances in methodological approaches, the growing integration of real-world evidence, and strengthened patient engagement are reshaping the drug development landscape.1

As the field continues to evolve, an important challenge has emerged: does the evidence we generate truly reflect the populations these medicines are intended to serve? Across industry, regulators and the wider research ecosystem, there is growing recognition that answering this question will be central to the next chapter of clinical research.2,3,4

At UCB, this commitment has shaped our approach to evidence generation for more than a decade. We have intentionally included the needs of special patient populations such as women of childbearing age from the earliest stages of development.

The future of clinical research is not only about broadening diverse participation in studies. It is about purposefully designing evidence generation from the onset to address the needs of diverse patient populations so that the evidence generated is relevant and meaningful throughout every stage of life.2,3,4 We call this ‘Start Early.’

Although women of childbearing age, children and the elderly have distinct physiological, developmental and life-stage needs, they share a common challenge: evidence relevant to their care is often not readily available when critical healthcare decisions are being made.2,3,4,5

Some examples of these data lags are significant; it takes between five and ten years for data on medicine use during pregnancy and breastfeeding to be incorporated into product labels.6 In paediatrics, medicines are approved for use around eight years after adult approval on average.7 And although our ageing population represent a growing proportion of healthcare needs,8 they remain substantially under-represented in clinical trials.9

The reasons behind the lack of evidence extends beyond scientific complexity. They also reflect how clinical research has traditionally been designed.5 Addressing them requires changing the narrative from the very beginning.

That means engaging with patients earlier, designing studies that capture outcomes that matter most to them, partnering with regulators throughout development and generating evidence that combines clinical trials, real-world evidence, and patient-reported outcomes.10,11 Ultimately, this is about generating evidence that reflects scientific rigour and relevance to real-world practice.

At UCB, our decade of experience advancing evidence generation for women of childbearing age living with chronic diseases has demonstrated what is possible when we start early and reinforce that patients are best protected through research, not from it.

As we look to the future, we are building on those learnings to strengthen our approach to ensure that children and the elderly are considered earlier in development and supported by evidence that reflects their unique needs.

One thing we learned: no single organisation can close these evidence gaps alone. Building a more representative evidence base requires collaboration between industry, patient organisations, regulators, researchers, healthcare professionals, and most importantly, patients themselves.

Ultimately, the future of clinical research will be defined not only by scientific innovation but also by our ability to design more inclusive research, generating the right data at the right time, and ensuring every patient has access to the data they deserve. 

1 Mahadik S, Sen P, Shah EJ. Harnessing digital health technologies and real-world evidence to enhance clinical research and patient outcomes. Digit Health. 2025;11:20552076251362097. doi: 10.1177/20552076251362097.

2 European Medicines Agency (EMA). ICH E11(R1) Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population – Step 5. EMA/CPMP/ICH/2711/1999. 2017. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e11r1-guideline-clinical-investigation-medicinal-products-pediatric-population-revision-1-addendum_en.pdf. Last accessed: July 2026.

3 International Council for Harmonisation. Final concept paper: E21 – Inclusion of pregnant and breast-feeding individuals in clinical trials. 2023. Available at: https://database.ich.org/sites/default/files/ICH_E21_Final_Concept_Paper_2023_1106_MCApproved.pdf. Last accessed: July 2026.

4 Jacobson RM, Pignolo RJ, Lazaridis KN. Clinical Trials for Special Populations: Children, Older Adults, and Rare Diseases. Mayo Clin Proc. 2024;99(2):318-35. doi:10.1016/j.mayocp.2023.03.003.

5 Mohan SV, Freedman J. A Review of the Evolving Landscape of Inclusive Research and Improved Clinical Trial Access. Clin Pharmacol Ther. 2023;113(3):518-27. https://doi.org/10.1002/cpt.2832.

6 Fernandes MFS, Alexe A, Apara O, et al. Post-approval activities providing data on the safety of medication use during pregnancy and lactation—a TransCelerate perspective. Ther Innov Regul Sci. 2025;59(3):527-41. doi:10.1007/s43441-025-00764-4.

7 Beleck A, Nachman S. Understanding pediatric drug lag time: review of selected drug package inserts. J Pediatric Infect Dis Soc. 2021;10(4):509-13. doi:10.1093/jpids/piaa136.

8 Karaflou M, Goulis DG. The growing challenge of aging populations: Addressing health and societal impacts. Maturitas. 2025;202:108720. doi:10.1016/j.maturitas.2025.108720.

9 Lau SWJ, Huang Y, Hsieh J, et al. Participation of older adults in clinical trials for new drug applications and biologics license applications from 2010 through 2019. JAMA Netw Open. 2022;5(10):e2236149. doi:10.1001/jamanetworkopen.2022.36149.

10 Vat LE, Finlay T, Jan Schuitmaker-Warnaar T, et al. Evaluating the “return on patient engagement initiatives” in medicines research and development: A literature review. Health Expect. 2020;23(1):5-18. doi: 10.1111/hex.12951.

11 Bertelsen N, Oehrlein E, Lewis B, et al. Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: Where Are We Today? Ther Innov Regul Sci. 2025;59(4):737-52. doi: 10.1007/s43441-025-00770-6.