By Omneya Mohamed
Healthcare systems worldwide are under pressure to make faster, smarter, and more sustainable decisions. In this context, Real-World Evidence (RWE) — patient data collected outside traditional clinical trials, from sources such as electronic health records, registries, and connected patient wearables — is becoming an indispensable tool.
Unlike randomized clinical trials (RCTs), which test treatments in controlled settings, RWE reflects how therapies and technologies perform in real life. This perspective is vital not only for regulators and payers, but also for providers and patients who need assurance of value and effectiveness in everyday practice.
Globally, RWE has gained significant traction, particularly in Europe and the United States, where it is being used to support regulatory approvals, reimbursement decisions, and post-market surveillance.
The momentum is also building in the Middle East and Africa (MEA). Regulators such as the Department of Health (DoH) Abu Dhabi and the Saudi Food and Drug Authority (SFDA) are beginning to explore how RWE can complement traditional evidence to shape smarter policy, faster approvals, and more informed reimbursement pathways.
For a region facing rising healthcare costs, diverse patient populations, and urgent needs for access and equity, the potential of RWE is immense.
Case studies worldwide highlight how RWE has already influenced healthcare decisions. In oncology, for example, RWE has been used to demonstrate treatment effectiveness across broader patient groups than those typically represented in clinical trials. Similarly, regulatory agencies have increasingly relied on RWE to validate safety and efficacy in rare diseases, where trial data may be limited.
In recent years, patient wearables have become one of the most promising sources of real-world data.
Devices such as smartwatches, glucose monitors, and connected inhalers are now generating continuous, real-time health data — capturing patient activity, heart rate, sleep quality, medication adherence, and symptom fluctuations outside clinical environments. This data provides regulators and manufacturers with richer evidence on how patients respond to therapies in everyday life.
For instance:
By integrating such data streams, RWE frameworks can move from retrospective analysis toward predictive, proactive health insights, supporting faster, evidence-based decision-making.
These examples show that RWE is not about replacing RCTs, but about complementing them — offering richer insights, longer-term follow-up, and context-specific evidence that can improve decision-making.
The MEA region has a unique opportunity to adopt RWE early and build frameworks suited to its diverse healthcare systems. By embedding RWE into regulatory and reimbursement structures, MEA policymakers can:
While the promise of RWE is clear, challenges must not be underestimated. Data quality, fragmentation across systems, and patient privacy remain pressing concerns. Without robust governance and transparent methodologies, RWE risks losing credibility and undermining trust.
This makes it critical for the MEA region to invest in:
At Mecomed, advancing evidence-based healthcare remains a cornerstone of our advocacy agenda. Through initiatives such as ISPOR UAE Chapter events and Regional HTA platforms, we continue to bring stakeholders together to exchange knowledge and chart a course for RWE adoption in MEA.
By publishing thought leadership on this subject, Mecomed aims to provide members with practical guidance while reinforcing our position as a trusted voice in shaping the region's healthcare future.