Учёные записки Санкт-Петербургского государственного медицинского университета им. Акад. И.П. Павлова (Mar 2018)

CLINICAL TRIAL RESULS AND REAL WORLD MEDICAL EVIDENCE GAP

  • A. V. Philippova,
  • A. S. Kolbin

DOI
https://doi.org/10.24884/1607-4181-2018-25-1-7-14
Journal volume & issue
Vol. 25, no. 1
pp. 7 – 14

Abstract

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This is a systematic literature overview concerning contemporary approaches to the gap between randomized clinical trials (RCT) results and the evidence within real world medical practice («efficacy-effectiveness gap, EEG»). The overview includes 18 articles and 1 publication by regulatory expert community. 13 articles describe the EEG using particular evidence and 5 articles discuss the issue systematically. According to the results of the observations, the authors of 16 articles concluded that this discrepancy exists, and the authors of 2 articles concluded that in their studies this discrepancy was not found. Upon current review it was concluded that the factors providing EEG can be divided into the following groups: subjective factors coming from healthcare system organization processes and the caregiver-patient intercommunication principles; objective factors coming from essential RCT limitations as a scientific method; and the artificial limitations always made within RCT taking intermediate position.

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