For decades, randomised controlled trials (RCTs) have been considered the gold standard of clinical research. But as healthcare data becomes digitalised, a growing number of researchers, regulators, and industry leaders are asking whether that gold standard is enough on its own.
Electronic health records (EHRs), disease registries, wearable devices, and real-time patient monitoring are generating unprecedented volumes of data, and the new challenge lies in turning that data into evidence.
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At the Outsourcing in Clinical Trials (OCT) UK & Ireland 2026 conference, which took place on 9–10 June in London, experts from industry, clinical practice, and agencies argued that real-world evidence (RWE) or real-world data (RWD) is approaching a tipping point and that the future of clinical research may depend as much on RWE as it does on traditional clinical trials.
Continuous patient monitoring and trial optimisation
The UK already possesses some of the world’s most valuable health data resources, including NHS EHRs, CPRD datasets, Scottish healthcare databases, and the UK Biobank, which allow researchers to study millions of patients across diverse populations, said Jonathan Wogel, CEO of Northwest eHealth (NWEH), a Manchester-based health-tech company that focuses on modernising clinical trials. Using CPRD, NHS records, and other large datasets during the trial design phase can help sponsors understand patient populations before a study begins.
NWEH develops software platforms that use real-world EHR data, which allows the NHS, higher education institutes, and pharmaceutical companies to streamline patient recruitment, monitor real-time safety, and conduct trials more cost-effectively.
Before conducting a clinical trial, using NHS datasets and regional data sources to understand where patients are located is crucial. Wogel gave the example of a 3,000-patient study conducted in Manchester to illustrate the value of understanding populations before trial launch. “RWE can inform site selection by identifying where eligible patient populations are concentrated and where recruitment is most likely to succeed,” he said.
The next step in RWE comes from collecting information from patients in real time through wearable devices, which is not only valuable for clinical development but also for market access, health technology assessment submissions, and understanding treatment effectiveness in routine practice.
Continuous monitoring through wearables and other digital technologies can also provide insights into how patients function in everyday life and identify what matters to them, which can lead to the development of novel and meaningful endpoints.
Historically, clinical trials have failed to represent diverse populations, and Wogel mentioned that the Covid-19 pandemic exposed how responses and patient outcomes varied among different age groups, genetic profiles, and ethnic backgrounds. Large-scale RWE and genomic resources such as the UK Biobank have helped researchers understand such patient differences. The industry is headed toward a more inclusive approach that looks beyond traditional trial populations and seeks evidence that reflects the diversity of real-world patients, Wogel noted.
How can clinical observation directly lead to innovation
Studying RWE can also help identify therapeutic innovations. Cambridge, UK-based Hypo-Stream is an emerging biotech focused on developing targeted anti-inflammatory medications and broad-spectrum antimicrobials. As a clinician seeking better outcomes for his patients, Hypo-Stream chairman and founder Myles Dakin had been using a well-known antiseptic within its approved indication for burn victims, and noted that the patients were doing better than anticipated. A blinded analysis of patient data demonstrated a survival benefit in patients receiving the same antiseptic treatment, Dakin noted. Moreover, a statistical review of the burn unit data indicated that patients with severe gram-negative infections who received the treatment appeared to have approximately five times the chance of survival of comparable patients who did not receive it, Dakin highlighted.
The compound was found to degrade interleukin-6 rapidly, potentially reducing inflammation in conditions like sepsis, Dakin added. In this case, this important finding did not come out of a clinical trial but rather from an observation in routine clinical practice. Perhaps the most significant aspect of this example is how regulators responded to it. Historically, RWE has been viewed as supportive evidence rather than primary evidence. In this case, however, RWE became the starting point for regulatory engagement. Researchers used blinded clinical datasets and independent statistical analyses to build an evidence package that ultimately supported orphan designation discussions and formal scientific advice with European regulators. The data was also considered strong enough to provide evidence comparable to Phase II trial results, said Dakin.
This case illustrates a broader shift in the industry, one in which regulators are increasingly willing to consider RWE as part of the development pathway, provided that the underlying data is robust, reproducible, and scientifically validated.
The obstacle of access
Despite the enthusiasm surrounding RWE, significant challenges remain.
Data access continues to be one of the biggest barriers identified by researchers and industry stakeholders. Data often exists in separate systems, governed by different organisations, collected using different methods, and stored in ways that make integration difficult.
For Wogel, access is only part of the problem, and an equally important challenge is ensuring that data collected across different healthcare settings can be trustworthy and comparable. “If you’ve got two cohorts that are supposedly similar, how do you know the data has been collected and coded in the same way?” Wogel asked. Differences in data entry, coding systems, and governance processes can create inconsistencies that make analysis difficult and limit the usefulness of otherwise valuable datasets.
The overarching message at the OCT UK and Ireland meeting was that finding meaningful evidence requires navigating multiple data sources; building relationships with clinicians, regulators, and institutions; and maintaining persistence. Dakin also said that translating a positive observation or signal into a development program requires scientific validation, expert collaboration, regulatory engagement, and most importantly, persistence.
While the UK holds some of the world’s richest healthcare data resources, these datasets are often fragmented across organisations and systems. Bringing them together in a standardised and validated way that supports research remains a significant challenge. The need of the hour is not just to generate data, but also to create the suitable infrastructure, governance, and partnerships needed to turn that data into meaningful evidence.
The Outsourcing in Clinical Trials UK & Ireland 2026 conference is hosted by Arena International Events Group, a B2B events company owned by GlobalData, the parent company of Clinical Trials Arena and Pharmaceutical Technology.
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