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FOUNTAIN: a modular research platform for integrated real-world evidence generation

  • 0Bayer AS, Oslo, Norway. niki.oberprieler@bayer.com.
Bmc Medical Research Methodology +

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October 1, 2024

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October 1, 2024

View abstract on PubMed

Summary

This summary is machine-generated.

The FOUNTAIN platform harmonizes real-world evidence (RWE) generation for finerenone studies. This approach enhances consistency and generalizability of RWE, improving clinical decision-making.

Area Of Science

  • Pharmacoepidemiology
  • Health Data Science
  • Clinical Research Informatics

Background

  • Real-world evidence (RWE) is crucial for regulatory and healthcare decisions.
  • Fragmented RWE can limit clinical utility due to heterogeneity and lack of reproducibility.
  • Harmonization of methodologies across data sources is essential to improve RWE quality.

Purpose Of The Study

  • To describe the multidisciplinary FOUNTAIN research platform (FinerenOne mUlti-database NeTwork for evidence generAtIoN).
  • To explore the strengths and limitations of harmonized RWE generation.
  • To provide insights into the real-world utilization, effectiveness, and safety of finerenone.

Main Methods

  • Established a multidisciplinary research platform (FOUNTAIN) with expert guidance.
  • Integrated diverse RWE generation approaches, including collaborations and a common data model (CDM).
  • Ensured harmonization of medical definitions, methodology, and reproducible artifacts across studies.

Main Results

  • The FOUNTAIN platform includes 9 research partner collaborations and 8 CDM-mapped data sources across 7 countries.
  • Six multicountry, multidatabase cohort studies are underway.
  • Ongoing studies focus on patient populations, standard of care, comorbidities, healthcare resource use, and finerenone's effectiveness and safety.

Conclusions

  • The FOUNTAIN platform enables harmonized execution of multiple studies, enhancing consistency.
  • It promotes consistency within studies using multiple data sources and across all platform studies.
  • FOUNTAIN offers a strategy to improve the consistency and generalizability of RWE for finerenone.

Keywords:

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