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 to play a more prominent role in the age of COVID-19.
Could this kind of information even be used to create virtual clinical trials? That’s a question the US Food and Drug Administration (FDA) has been grappling with since the passage of the 21st Century Cures Act in 2016.
That law requires the FDA to use real-world evidence (RWE) in its regulatory decisions, including approval of new indications for previously approved drugs. These new indications can gain approval through a more streamlined process because the agency assumes that the clinical trials for the original approval established the drug’s safety.
Abdel-Kader K, Jhamb M. EHR-based clinical trials: the next generation of evidence. Clin J Am Soc Nephrol 2020; 15:1050–1052. doi: 10.2215/CJN.11860919
Thompson AM, Southworth MR. Real world data and evidence: support for drug approval: applications to kidney diseases. Clin J Am Soc Nephrol 2019; 14:1531–1532. doi: 10.2215/CJN.02790319