Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in Europe.

Zachary P SmithEmily BottoKenneth Getz

Published in: Therapeutic innovation & regulatory science (2022)

Guidelines encouraging the reporting of patient demographic data are insufficient and availability of the data is problematic. The available data suggest that under-representation in pivotal trials is widespread.

Keyphrases

electronic health record
big data
data analysis
emergency department
neural network