From data to impact: How real-world evidence will transform healthcare

Healthcare generates massive volumes of data daily – from electronic health records and insurance claims to genomic research and wearable devices. Recent analyses from RBC Capital Markets estimate that healthcare accounts for approximately 30% of global data production.
By 2025, healthcare data is projected to grow at an annual rate of 36% - outpacing industries like manufacturing, financial services, and media by as much as 11%. While efforts to improve interoperability have expanded data accessibility, simply collecting more data is no longer sufficient.
The industry’s future depends on generating evidence that’s not only fast, but also credible and actionable.
Raw data alone cannot reliably answer essential questions about safety, effectiveness, or economic value. Informed decision-making requires evidence grounded in scientifically validated methodologies, whether for clinical development, regulatory approval, or patient care.
Today, regulators, payers, and providers demand insights that reflect real-world clinical settings, not just controlled trial environments. They need timely, reliable evidence to guide decisions across diverse patient populations and care contexts. Real-world evidence (RWE) has moved from the periphery to the centre of how healthcare decisions are made.
From data to decisions
Real-world data (RWD) holds tremendous promise. However, without rigorous scientific approaches, RWD can lead to inaccurate conclusions, rather than genuine insights. Variability in patient demographics, data quality, and clinical contexts can significantly undermine decision reliability.
Without rigorous methods, transparency, and reproducibility, it’s information – but not evidence.
This distinction matters. Stakeholders need results that withstand scrutiny by regulatory bodies, health authorities, and clinicians. RWE's true strength lies in its ability to reliably address real-world questions, moving beyond correlation to credible evidence that genuinely informs clinical and policy decisions.
Structured RWE for better outcomes
To maximise its value, real-world evidence must be integrated into healthcare product development far earlier than current practice. Adopting this structured methodology early can reduce costly delays, strengthen regulatory submissions, and lay a solid foundation for market access strategies. Early investment in rigorous methods can significantly increase the likelihood of regulatory success and improve patient outcomes.
Accelerating market access with RWE
Beyond development, RWE is transforming the pathway treatments take to reach patients. Demonstrating real-world effectiveness and comparative economic value is also crucial in value-based care models. Payers need evidence clarifying whether a therapy works, not only for whom it works best, but also at what cost relative to alternatives. Real-world evidence provides these insights, influencing reimbursement and coverage decisions by clarifying patient outcomes, adherence, and treatment patterns.
For life sciences companies, incorporating RWE early into clinical strategies and commercialisation planning can streamline payer negotiations, accelerate market access, and substantiate pricing decisions. Consider gene therapies, where limited long-term trial data exists. In such cases, RWE derived from early patient populations can decisively inform coverage decisions, proving indispensable for successful market entry.
Global momentum in regulatory adoption of RWE
Regulators worldwide are formalising the use of RWE in their approval and surveillance processes. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued clear guidance for incorporating RWE in regulatory submissions, labelling expansions, and post-market monitoring.
This shift reflects a growing recognition that real-world evidence complements traditional clinical trials by providing insights into how treatments perform across diverse patient populations and everyday clinical settings. In some instances, RWE may even be an alternative to randomised trials – especially when such trials are infeasible or raise ethical concerns.
Organisations proficient in generating transparent and rigorous RWE are strategically positioned for success as global regulatory frameworks increasingly integrate and prioritise this evidence. Those who invest early in robust RWE capabilities will keep pace and help shape the standards and expectations that define the future of evidence-based healthcare.
Countries across the Asia-Pacific and Latin America also embrace RWE for health technology assessments and reimbursement decisions, signalling a broader international alignment. This global momentum fosters greater collaboration and creates a shared benchmark for healthcare evidence – laying the foundation for more harmonised, data-driven decision-making worldwide.
Ensuring trust through privacy and scientific integrity
As RWE plays a greater role in shaping healthcare decisions, privacy and trust are non-negotiable. Patients must be confident that their data is protected, while stakeholders need assurance that privacy safeguards do not compromise the scientific validity of the insights derived.
Advanced de-identification techniques, strong data governance, and strict adherence to global privacy standards make it possible to conduct meaningful analysis without sacrificing confidentiality. Equally important is transparency – clarity in how evidence is generated, validated, and applied fosters the trust necessary for widespread adoption. Methodological rigour, documented processes, and reproducible results ensure that RWE meets the high standards expected by regulators, payers, and clinicians in every major healthcare market.
Leading healthcare forward
Real-world evidence is no longer supplemental – it’s a critical force behind smarter decisions, stronger policies, and better outcomes. The ability to turn raw data into credible, actionable evidence now defines leadership in healthcare.
The future of healthcare will not be shaped by how much data we collect, but by the quality and credibility of the evidence we deliver.
Organisations that produce timely, scientifically rigorous, and transparent RWE will lead the next wave of healthcare innovation. Those that fail to adapt risk falling behind in an increasingly evidence-driven landscape. Now is the time for healthcare leaders to embed RWE into their core strategies, driving progress that is both meaningful and centred on patient needs.
About the author
Natalie Schibell is vice president of market strategy and communications at Aetion, where she oversees enterprise market intelligence, competitive insights, and strategic positioning across healthcare and life sciences sectors. Previously, she held multiple leadership roles at Forrester, including VP and research director, and VP principal analyst. She was also a public health analyst at the Centers for Disease Control and Prevention’s National Center for Emerging and Zoonotic Infectious Diseases. A former Lieutenant Commander in the United States Navy Medical Service Corps, Schibell is a recognised author and speaker specialising in healthcare innovation and strategic market insights. She holds a Master of Public Health from New York Medical College and is a Delta Omega Honorary Society in Public Health member.