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From clinical trials to clinical practice: How long are drugs tested and then used by patients? How long are drugs tested and then used by patients?

  • Chi Yuan
  • , Patrick B. Ryan
  • , Casey N. Ta
  • , Jae Hyun Kim
  • , Ziran Li
  • , Chunhua Weng*
  • *Corresponding author for this work
  • Columbia University
  • Johnson & Johnson

Research output: Contribution to journalJournal articlepeer-review

Abstract

Objective: Evidence is scarce regarding the safety of long-term drug use, especially for drugs treating chronic diseases. To bridge this knowledge gap, this research investigated the differences in drug exposure between clinical trials and clinical practice. Materials and Methods: We extracted drug follow-up times from clinical trials in ClinicalTrials.gov and compared the difference between clinical trials and real-world usage data for 914 drugs taken by 96 645 927 patients. Results: A total of 17.5% of drugs had longer median exposure in practice than in trials, 6% of patients had extended exposure to at least 1 drug, and drugs treating nervous system disorders and cardiovascular diseases were the most common among drugs with high rates of extended exposure. Conclusions: For most of patients, the drug use length is shorter than the tested length in clinical trials. Still, a remarkable number of patients experienced extended drug exposure, particularly for drugs treating nervous system disorders or cardiovascular disorders.

Original languageEnglish
Pages (from-to)2456-2460
Number of pages5
JournalJournal of the American Medical Informatics Association
Volume28
Issue number11
DOIs
StatePublished - 2021.11.1

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

  1. SDG 3 - Good Health and Well-being
    SDG 3 Good Health and Well-being

Keywords

  • evidence-based medicine
  • follow-up studies
  • prescription drug overuse
  • randomized controlled trials
  • validation study

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