Home » CHMP: Sponsors Should Consider Factors in Extrapolating Data
CHMP: Sponsors Should Consider Factors in Extrapolating Data
Sponsors wanting to extrapolate data from
drug trials conducted outside the EU for marketing approval within the EU need to address several factors that could affect the applicability of the data,
the Committee for Medicinal Products for Human Use (CHMP) says. Three major factors to consider are differences in medical practice, disease definition
and the study population, CHMP says in a reflection
paper posted on its website.
Clinical Trials Advisor
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