• 1.

    Abdel-Kader K, Jhamb M. EHR-based clinical trials: the next generation of evidence. Clin J Am Soc Nephrol 2020; 15:10501052. doi: 10.2215/CJN.11860919

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 2.

    Thompson AM, Southworth MR. Real world data and evidence: support for drug approval: applications to kidney diseases. Clin J Am Soc Nephrol 2019; 14:15311532. doi: 10.2215/CJN.02790319

    • Crossref
    • Search Google Scholar
    • Export Citation

FDA Looks to Increase Role of Real-World Evidence in Regulatory Decisions

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As the COVID-19 pandemic shows no sign of abating and healthcare providers struggle to find effective treatments, valuable information is accumulating in electronic health records (EHRs). Researchers used this information—in observational studies—early in the pandemic when an alarm was raised that blood pressure medications based on renin-angiotensin system inhibition posed a theoretic threat to COVID-19 patients. Studies that mined EHRs found no signal of harm to patients who continued to take these medications. Expert guidelines quickly reflected this.

Clinical trials are difficult to run during a pandemic, making the information from EHRs and other forms of real-world data (RWD) poised

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