Natalie Schibell, MPH and Pippa Hodgkins
As healthcare systems navigate increasingly complex clinical, regulatory, and market challenges, the demand for rigorous real-world evidence (RWE) continues to grow. Systematic analysis of historical patient data is essential for refining study parameters, assessing population trends, and identifying risk factors with confidence and precision.
Aetion® Substantiate features Population Exploration, an interactive tool designed to examine real-world patient populations at scale. Insights into demographic distributions, treatment exposure, and disease patterns support study feasibility, hypothesis generation, and evidence development for regulatory and market access decisions.
A Smarter Approach to Study Planning in RWE
Real-world data (RWD) is critical for evaluating treatment effects, disease progression, and healthcare utilization. Researchers with a clear study objective use a structured approach, defining study populations based on pre-specified inclusion criteria and code lists. These methods ensure well-characterized study groups and enable precise population analysis, but they may require refinements when broader exploration is needed to uncover unexpected patterns.
In other cases, researchers must explore further to determine the best approach for cohort construction. Population Exploration in Substantiate enhances traditional approaches by offering a dynamic, interactive capability for early-stage study planning and feasibility assessments. When researchers lack predefined characteristics, Population Exploration surfaces key fields in the data without requiring code lists or predefined parameters. This flexibility enables researchers to quickly visualize demographic trends, assess treatment exposure, and explore disease prevalence before moving into more complex statistical analyses. By integrating these exploratory capabilities with established cohort selection methodologies, Population Exploration strengthens regulatory submissions and improves healthcare decision-making.
Population Exploration in Substantiate
Population Exploration streamlines cohort analysis, delivering insights into demographics, comorbidities, and treatment patterns. These insights help refine eligibility criteria, identify subpopulations, and improve study feasibility, strengthening study design and evidence generation.
Core Capabilities of Population Exploration
- Summarizes patient populations based on demographic distributions, comorbidities, and treatments.
- Supports early-stage study planning by refining eligibility criteria and identifying subpopulations relevant to clinical and regulatory objectives.
- Generates population-level distributions to guide cohort selection, assess study feasibility, and inform long-term research strategies.
New: Baseline Period Attributes
To further expand analytical capabilities, Baseline Period Attributes provide deeper insights into patient characteristics before cohort entry, allowing researchers to:
- Identify the top 10 generic drugs prescribed in the 180 days prior to cohort entry, offering a clearer picture of pre-treatment medication use.
- Quantify the top 30 inpatient ICD-10 codes across the dataset timeline, helping assess disease burden and healthcare utilization trends.
These enhancements add greater granularity and historical context, enabling a comprehensive view of patient populations over time.
Once cohorts are refined, researchers can further analyze treatment exposure and dosing patterns using Substantiate’s Drug Computation capabilities. These capabilities provide precise medication adherence, dose calculations, and drug coverage insights to strengthen evidence generation.
Driving Research Impact Across Healthcare
Population Exploration strengthens real-world evidence generation by providing structured, scalable cohort analysis supporting key healthcare stakeholders.
Population Insights and Study Feasibility Across Stakeholders
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For research teams requiring greater flexibility and control over statistical modeling, Custom Analyses in Substantiate enables direct coding in RStudio, allowing users to refine study outputs and enhance reproducibility in a secure research environment.
Aetion’s Commitment to Scientific Excellence
Aetion’s Population Exploration framework is built on validated epidemiologic methodologies and ensures scientific rigor, transparency, and reproducibility in exploratory analyses. Ongoing enhancements refine analytic capabilities, equipping researchers with decision-ready evidence that withstands regulatory and peer scrutiny. Expanding these capabilities within real-world evidence generation establishes a robust foundation for study design, cohort analysis, and regulatory decision-making.
Harness the Full Potential of Population Exploration
Extracting meaningful insights from patient populations requires advanced analytics and deep scientific expertise. Aetion’s experts help researchers maximize the capabilities of Population Exploration in Substantiate, refining study criteria, assessing feasibility, and generating decision-grade evidence that meets regulatory and market needs.
Aetion Substantiate provides a comprehensive framework for real-world evidence generation. From Population Exploration for cohort selection to Drug Computation for dose analysis and Custom Analyses for advanced statistical modeling, Substantiate enables researchers to produce rigorous, transparent, and defensible evidence.
Let’s talk about how Aetion’s expertise can strengthen your research.