AetionMar 27, 20253 min read

Ensuring Accuracy in Real-World Epidemiology: How Aetion® Substantiate Delivers Reliable Prevalence and Incidence Estimates

Aetion® Substantiate: A Solution for Reliable, Decision-Grade Epidemiology

Prevalence and incidence (P&I) are essential epidemiologic measures that inform regulatory decisions, market access strategies, and public health planning. These metrics provide critical insights into disease burden, treatment patterns, and healthcare resource allocation, shaping policies on drug development, reimbursement, and clinical guidelines.

However, estimating P&I in real-world data (RWD) presents significant challenges. Incomplete data capture, inconsistent follow-up, and variability in healthcare utilization can distort these measures, leading to inaccurate assessments of disease burden, treatment uptake, and patient populations. Without rigorous methodologies, regulatory and payer decisions may be based on flawed evidence.

Aetion® Substantiate is designed to overcome these challenges by applying structured epidemiologic frameworks that ensure transparent, reproducible, and decision-grade prevalence and incidence estimates.

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Challenges in Real-World Prevalence and Incidence Estimation

Unlike clinical trials, real-world datasets reflect actual patient care, introducing complexity into epidemiologic estimation:

Enrollment variability: Patients transition between insurance plans, providers, and care settings, leading to fluctuations in denominator calculations.
Gaps in medical histories: Incomplete or fragmented data can distort disease onset and treatment exposure estimates.
Inconsistent follow-up periods: Observational timeframes vary, requiring adjustments to avoid overestimating incidence rates.

Aetion co-founders Jeremy Rassen, ScD, and Sebastian Schneeweiss, MD, ScD, have extensively studied how study design choices—such as cohort selection, lookback periods, and data observability—impact prevalence and incidence estimates. Substantiate applies these principles to ensure epidemiologic accuracy and regulatory-grade decision-making.

How Aetion Substantiate Ensures Reliable, Regulatory-Grade Estimates

Aetion Substantiate includes all the prevalence and incidence analytics of Aetion® Discover, with added structured epidemiologic frameworks, customizable lookback windows to distinguish new cases from pre-existing conditions, and time-series tracking—delivering validated, decision-grade estimates for clinical, regulatory, and market access decisions.

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Dynamic Cohort Definitions

Variability in patient enrollment can lead to inaccurate prevalence and incidence estimates. Substantiate applies dynamic cohort definitions, ensuring estimates reflect only actively observed patient periods, improving denominator accuracy, and preventing inflated estimates.

Standardized Incidence Rate Calculations

Traditional epidemiologic models assume uniform follow-up, which does not reflect real-world healthcare utilization. Substantiate applies structured person-time adjustments, ensuring incidence estimates remain consistent, comparable, and suitable for regulatory review.

Distinguishing New Cases from Pre-Existing Conditions

Without properly defined washout periods, patients with prior diagnoses may be misclassified as new cases, distorting incidence rates. Substantiate integrates customizable lookback windows, systematically removing pre-existing cases to maintain epidemiologic accuracy.

Supporting Subgroup and Stratified Analyses

Disease burden varies across age groups, demographics, comorbidities, and geographic regions. Identifying high-risk populations is critical for precision medicine, regulatory reviews, and payer evaluations. Substantiate enables granular stratification, allowing for targeted epidemiologic and payer-driven analyses.

Tracking Disease Burden Over Time

Prevalence and incidence shift due to treatment innovations, policy changes, and evolving healthcare access. Decision-makers need longitudinal tracking to inform post-market safety monitoring and reimbursement strategies. Substantiate generates time-series prevalence and incidence estimates, providing reliable real-world epidemiologic insights.

Who Benefits from Aetion Substantiate?

Key Stakeholders in Clinical, Regulatory, and Public Health

Category	Key Applications
Regulatory and Clinical Development	Regulatory agencies rely on transparent, scientifically rigorous prevalence and incidence estimates to evaluate drugs, support post-market surveillance, and assess clinical trial feasibility.
	Clinical trial feasibility assessments: Ensuring recruitment strategies align with real-world disease prevalence. Post-market safety monitoring: Tracking treatment utilization and long-term safety in real-world populations.
Market Access and HEOR	Payers and health technology assessment (HTA) bodies require robust epidemiologic estimates for pricing, reimbursement, and formulary decisions.
	Strengthening payer negotiations: Providing real-world prevalence and incidence data to define eligible patient populations and evaluate treatment impact. Healthcare resource utilization insights: Identifying cost drivers and trends in disease burden to inform value-based pricing strategies.
Public Health and Population Surveillance	Public health agencies require real-time epidemiologic surveillance to guide pandemic preparedness, health equity initiatives, and resource allocation.
	Tracking disease burden across populations: Detecting early epidemiologic shifts and emerging trends. Informing national and global health policy: Ensuring interventions are based on real-world epidemiologic evidence.

Aetion Substantiate delivers scientifically validated, transparent, and regulatory-aligned epidemiologic insights, strengthening decision-making across the healthcare ecosystem.

Lead with Confidence in Real-World Epidemiology

Regulatory agencies, payers, and public health organizations rely on rigorous, transparent, and reproducible epidemiologic insights to make decisions that shape healthcare outcomes. Inaccurate estimates introduce risk—Aetion Substantiate removes the uncertainty.

Built on a structured, regulator-trusted framework, Substantiate delivers scientifically sound, decision-ready prevalence and incidence estimates that align with global regulatory expectations.

Ensure your epidemiologic analyses meet the highest scientific and regulatory standards—schedule a consultation to explore how Aetion Substantiate can strengthen your real-world evidence strategy.