Open AccessImproving Realism in Clinical Trial Simulations via Real‐World Data
Author(s) -
Kimko Holly,
Lee Kwan
Publication year - 2017
Publication title -
cpt: pharmacometrics and systems pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 37
ISSN - 2163-8306
DOI - 10.1002/psp4.12232
Subject(s) - clinical trial , drug development , real world data , sampling (signal processing) , representation (politics) , medical physics , medicine , computer science , data science , drug , intensive care medicine , pharmacology , pathology , filter (signal processing) , politics , political science , law , computer vision
Simulation validity depends on how well sampling distributions used reflect real‐patient characteristics, such as drug adherence, disease progression, and pharmacologic handling in the body. We challenge the current use of growth charts from nondisease‐specific pediatrics in simulations for drug development. Complementary use of data from clinical trials and the real‐world is expected to achieve a more realistic representation of clinical outcomes for decisions in drug development, regulatory approval, and health technology assessment.