• ISSN 1674-8301
  • CN 32-1810/R
Volume 36 Issue 3
May  2022
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Daohong Chen. Real-world studies: bridging the gap between trial-assessed efficacy and routine care[J]. The Journal of Biomedical Research, 2022, 36(3): 147-154. doi: 10.7555/JBR.36.20220040
Citation: Daohong Chen. Real-world studies: bridging the gap between trial-assessed efficacy and routine care[J]. The Journal of Biomedical Research, 2022, 36(3): 147-154. doi: 10.7555/JBR.36.20220040

Real-world studies: bridging the gap between trial-assessed efficacy and routine care

doi: 10.7555/JBR.36.20220040
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  • Corresponding author: Daohong Chen, Research Institute, Changshan Biochemical Pharmaceutical, North Head of Yinchuan Street, Zhengding New District, Shijiazhuang, Hebei 050800, China. Tel: +86-311-89190128, E-mail: daohong@hotmail.com
  • Received: 2022-03-02
  • Revised: 2022-03-20
  • Accepted: 2022-03-25
  • Published: 2022-05-10
  • Issue Date: 2022-05-27
  • Even though randomized controlled clinical trials (RCTs) have been accepted as the gold standard for official assessment of novel interventions, there is a substantial gap between the efficacy observed in RCTs and the impact on clinical practice and in terms of patient benefit. While real-world studies (RWS) are emerging to confer valuable complementing evidence in this regard and beyond, the evolving role of RWS is yet to be agreed. This article delineates an updated profile of RWS covering effectiveness verification, rare adverse effects discovery, indication repurposing, to name a few. RWS tends not only to improve the efficiency of clinical investigations for regulatory approval, but also optimizes the whole-life cycle evaluation of biomedical/pharmaceutical products.


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