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Related Experiment Videos

Letizia Dondi1, Giulia Ronconi1, Leonardo Dondi1

  • 1Fondazione ReS (Ricerca e Salute), Roma.

Recenti Progressi in Medicina
|December 17, 2024
PubMed
Summary

Real-World Evidence (RWE) aids drug development by identifying target populations (TPs) using healthcare data. This research analyzes TPs across 15 areas, informing healthcare and pharmaceutical sectors.

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Area of Science:

  • Pharmacovigilance and Drug Development
  • Health Informatics
  • Epidemiology

Context:

  • Real-World Evidence (RWE) is crucial throughout the drug lifecycle, particularly in pre-marketing phases for identifying and analyzing target populations (TPs).
  • Administrative healthcare databases are utilized to develop and refine algorithms for TP selection and analysis.
  • The Research and Health Foundation (ReS) collaborates with experts to advance RWE applications.

Purpose:

  • To analyze target populations (TPs) for new drugs and indications using administrative healthcare data.
  • To provide insights into disease prevalence, incidence, patient characteristics, and healthcare costs.
  • To support healthcare institutions and pharmaceutical companies in strategic decision-making.

Summary:

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  • Algorithms have been developed to analyze 85 TPs across 15 clinical areas, with oncology being the most represented.
  • Findings include disease prevalence/incidence, patient demographics, and direct costs to the Italian National Health Service.
  • The study highlights the utility of RWE in understanding specific patient subpopulations.

    • Impact:

    • Informs healthcare institutions and pharmaceutical companies about patient populations and associated costs.
    • Supports strategic planning in drug development and market access.
    • Future work will integrate artificial intelligence and synthetic data for enhanced TP analysis and regulatory support.