As a founder of NWEH and a pioneer behind the Salford Lung Study, Professor Martin Gibson brings deep clinical insight to the evolving landscape of real-world evidence. In this blog, Martin shares his expert perspective on how RWE is transforming clinical research and improving outcomes across the healthcare ecosystem.
Introduction
Real-world evidence (RWE) has rapidly emerged as a pivotal component of clinical research, reshaping the landscape of drug development, and patient care. Pharmaceutical and biotech companies, regulatory agencies, healthcare researchers, and digital health innovators increasingly use RWE to complement traditional clinical trials, drive regulatory approvals, and enhance clinical outcomes. However, it is crucial to understand that real-world trials, which incorporate real-world data into clinical trial platforms, differ significantly from traditional RWE studies.
What is Real-World Evidence (RWE)?
RWE refers to clinical evidence derived from the analysis of real-world data (RWD), which includes information collected outside traditional controlled trials. Primary sources include:
While RWD comprises raw, unprocessed patient data from these sources, RWE emerges when RWD is analysed to generate actionable insights. Real-world evidence thus provides a comprehensive view of patient experiences, treatment effectiveness, and healthcare delivery patterns beyond controlled environments.
Real-World Trials vs. Real-World Evidence
Real-world trials are prospective studies that incorporate real-world data directly into clinical trial platforms, significantly enhancing traditional clinical trials. This contrasts with conventional RWE, which predominantly relies on retrospective data analysis. Integrating RWD directly into trial platforms provides real-time monitoring, drastically streamlining trial safety and measurement of outcomes. Crucially, it reduces the extensive auditing typically required, as data is captured directly from verified sources such as NHS and other healthcare records.
Real-world trials offer notable advantages over more traditional studies, including substantial cost savings and the potential to increase the patent life of medicines. These trials are specifically designed for practical real-world scenarios, significantly reducing patient burden and thereby improving participant retention. Enhanced retention minimises patient dropouts and loss to follow-up, resulting in more comprehensive datasets to support regulatory submissions. Furthermore, trials designed with real-world data can inherently possess improved internal and external validity, thereby delivering more generalisable data. Such generalisability streamlines healthcare system uptake by providing insights that are relevant for healthcare funding and health technology assessments (HTA).
Importantly, real-world trials more accurately reflect the broader patient population, including variations in sex, age, social deprivation, and ethnicity. This inclusivity enhances trial outcomes, providing richer insights into treatment effectiveness across diverse demographic groups, ultimately facilitating more equitable healthcare delivery.
How Regulators Utilise Real-World Evidence
Regulatory agencies such as the MHRA, EMA, and FDA are increasingly integrating regulatory-grade RWE into drug approval processes and healthcare decision-making. Examples include:
Regulators acknowledge that high-quality, validated RWE can complement traditional randomised clinical trials (RCTs), enhancing the robustness of evidence presented for licensing decisions.
Why RWE is Critical in Healthcare
Accelerating Drug Development & Regulatory Approvals
RWE supports:
Enhancing Clinical Decision-Making & Personalised Medicine
Clinicians harness RWE to deliver personalised treatments tailored to real-world patient outcomes, thus improving overall healthcare quality. Benefits include:
Improving Access & Equity in Healthcare
RWE helps address the underrepresentation of diverse patient populations in traditional clinical trials, promoting health equity. It enables:
Reducing Healthcare Costs & Optimising Resource Allocation
Utilising predictive analytics on RWD can significantly reduce healthcare costs by:
NWEH's Role in Leveraging Electronic Healthcare Data for Pharma
NorthWest EHealth (NWEH) is pioneering the secure and compliant integration of NHS and other electronic healthcare data to generate high-quality, regulatory-grade RWE. NWEH’s ConneXon platform is unique in delivering Real-World Trials by directly incorporating RWE from consented participants into a fully functional EDC. This permits pharmaceutical companies to conduct clinical trials that:
NWEH's collaboration in major studies, including GSK’s Salford Lung Studies and Novartis' Victorian-SPIRIT trial, highlights their expertise and track-record in conducting pioneering real-world trials that demonstrate significant clinical benefits, cost savings, and improved patient outcomes.
Conclusion
Real-world evidence is fundamentally transforming healthcare, facilitating smarter drug development, improving clinical decision-making, and providing more equitable patient outcomes. Leveraging electronic healthcare data and advanced analytics, organisations like NWEH ensure the robust generation of regulatory-grade RWE, empowering pharmaceutical companies and healthcare providers to deliver safer, more effective, and personalised care.
By clearly distinguishing between real-world trials and traditional real-world evidence, stakeholders can better harness the potential of RWD, substantially reducing clinical trial costs, enhancing patient safety, extending patent life, and accelerating healthcare innovation. This collectively benefits to the life sciences industry, healthcare providers and, crucially, accelerates the availability of new medicines to patients.