Ashley Jaksa, MPH and Natalie Schibell, MPH
Real-World Evidence (RWE) has evolved from limited application to an essential driver of transformative healthcare decision-making. Advances in robust real-world data (RWD), coupled with the urgent need for better outcomes, have positioned RWE at the forefront of healthcare innovation. Across payers, providers, biopharma, and regulatory bodies, RWD is reshaping how organizations generate insights, deliver value, and achieve measurable impact. However, achieving enterprise-wide RWE adoption demands navigating a complex and multifaceted landscape.
Aetion’s maturity model outlines a clear, four-phase framework for organizations navigating this evolution. It reflects the distinct challenges, opportunities, and milestones that come with integrating RWE into every facet of decision-making. This model provides a strategic guide for organizations to realize the full power of RWE, turning data into defensible, actionable evidence.
Phase 1: RWE Led by Individual Champions
In the initial phase, RWE initiatives are driven by individual champions or small teams exploring its potential. These early adopters see the untapped power of RWD to address critical questions but often face limited resources and infrastructure to scale their efforts.
How this looks in practice:
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Biopharma: RWD is introduced to build contextual understanding of diseases and indications, while advanced applications, such as external control arms, continue to evolve.
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Regulators: Observational studies with a narrow scope—targeting specific drugs or disease areas—leverage RWD for safety signal detection, while early efforts to integrate RWE from manufacturers begin to inform regulatory and policy decisions.
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Providers: Localized RWE studies examine treatment effectiveness, but insights are siloed due to the lack of a system-wide data strategy.
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Payers: Early use of RWD focuses on claims analysis for reporting. However, limited infrastructure and resources constrains broader applications.
At this stage, organizations lay the foundation for RWE adoption but require institutional support to achieve scalability.
Phase 2: RWE as a Tactical Solution
In Phase 2, organizations start leveraging RWE for specific, high-priority challenges. While these efforts demonstrate its value, they often remain disconnected from enterprise-wide strategies and lack comprehensive infrastructure.
Tactical applications include:
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Biopharma: RWE is deployed for targeted regulatory submissions, such as safety data for label extensions. However, fragmented data sources restrict broader strategic use.
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Regulators: RWE supports post-market safety assessments and limited decision-making processes, with integration into regulatory frameworks still developing.
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Providers: Clinical departments, particularly in specialties like oncology, use RWE to optimize protocols. Yet, the lack of interoperable EHR systems inhibits cross-departmental insights.
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Payers: RWE is applied in program evaluation and limited population health studies, providing insights into specific initiatives or interventions. However, the absence of real-time integration limits broader risk management capabilities.
This phase highlights RWE’s potential as a decision support tool while underscoring the need for systems-level alignment to maximize its impact.
Phase 3: RWE as an Operational Mandate
As organizations progress into Phase 3, RWE becomes an operational mandate. It is integrated into decision-making processes across multiple functions, moving beyond isolated initiatives. However, challenges such as data silos and fragmented systems persist, limiting full enterprise adoption.
Operational applications in Phase 3 include:
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Biopharma: RWE supports lifecycle management, enabling alignment between clinical, regulatory, and commercial functions.
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Regulators: RWE informs routine monitoring and selective regulatory decisions, with structured real-world data feeds gradually being integrated into policy frameworks.
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Providers: RWE is embedded into clinical pathways, helping to improve patient outcomes using real-time data. However, centralized RWE infrastructure remains a work in progress.
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Payers: RWE drives proactive disease management, risk stratification, and value-based care metrics, though disparate systems still challenge data harmonization.
Phase 3 reflects the growing reliance on RWE as a core operational asset while underscoring the need for cross-functional collaboration.
Phase 4: RWE as a Strategic Competitive Advantage
At the highest level of maturity, organizations use RWE as a strategic asset, fully integrated into enterprise-wide operations. Aetion enables this transformation by providing a scalable platform, centralized governance, and harmonized, fit-for-purpose data infrastructure that aligns RWE efforts with overarching organizational goals.
Aetion’s model drives leadership in Phase 4:
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Biopharma: Continuous RWE integration accelerates adaptive trial designs, regulatory submissions, and patient-centric strategies. Centers of Excellence (COEs) foster collaboration between R&D and commercial teams, transforming insights into impactful actions.
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Regulators: Near real-time pharmacovigilance and policy-making leverage structured real-world data streams, enabling proactive public health interventions.
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Providers: Evidence-based care at scale is supported by predictive models and centralized RWE hubs, enhancing precision medicine and collaborative research.
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Payers: RWE powers predictive analytics for risk modeling, population health insights, and dynamic reimbursement frameworks. Integration of claims, clinical, and social determinants enables payors to differentiate their offerings by demonstrating value, optimizing outcomes, and improving cost efficiency.
Phase 4 positions organizations as industry leaders, shaping healthcare innovation and delivering measurable results.
Achieving Enterprise RWE Maturity with Aetion
Realizing the full potential of RWE requires more than just technology—it demands leadership, collaboration, and a commitment to advancing healthcare through defensible, data-driven insights. With Aetion’s expertise, your organization can confidently navigate the journey to enterprise-wide RWE integration, driving measurable impact, improving patient outcomes, and effectively navigating the policy landscape.
Lead the Future of Evidence-based Decision-Making
Partner with Aetion to transform RWE into your competitive advantage. Contact us today to explore how we can support your journey to becoming a leader in real-world evidence generation and application.