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Updated: Aug 15, 2025

Evidence-based Knowledge Synthesis and Hypothesis Validation: Navigating Biomedical Knowledge Bases via Explainable AI and Agentic Systems
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Real-World Evidence: A Primer.

Amit Dang1

  • 1MarksMan Healthcare Communications, J1309, Amethyst Tower, PBEL City, Peeramcheruvu Village, Rajendra Nagar Mandal, Hyderabad, Telangana, 500091, India. amit.d@marksmanhealthcare.com.

Pharmaceutical Medicine
|January 5, 2023
PubMed
Summary

Real-world evidence (RWE), derived from real-world data (RWD), offers insights into medical product safety and efficacy. RWE is increasingly accepted and utilized across the drug lifecycle, despite data challenges.

Area of Science:

  • Clinical research methodology
  • Health informatics
  • Pharmacovigilance

Background:

  • Real-world data (RWD) is gathered from routine healthcare, including EHRs, registries, and patient-generated data.
  • RWD sources encompass electronic health records, claims data, registries, and data from mobile health devices.
  • Various study designs, including cohort studies and pragmatic trials, analyze RWD to generate real-world evidence (RWE).

Purpose of the Study:

  • To review current information on real-world evidence (RWE).
  • To outline the advantages, disadvantages, and challenges of RWE.
  • To discuss future directions for RWE utilization in drug development and regulatory processes.

Main Methods:

  • Literature review of real-world evidence (RWE) applications.

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  • Analysis of RWD sources and study designs.
  • Examination of stakeholder acceptance and regulatory frameworks for RWE.

    • Main Results:

    • Real-world evidence (RWE) is crucial for post-marketing surveillance and pharmacovigilance.
    • RWE applications extend beyond safety to drug approval and optimizing clinical trial design.
    • Growing acceptance of RWE by physicians, industry, payers, regulators, and patients is noted.

    Conclusions:

    • Real-world evidence (RWE) is a valuable tool in drug development and regulatory science.
    • Addressing challenges in RWD collection and analysis is key to maximizing RWE benefits.
    • The future of RWE involves broader integration into healthcare decision-making and research.