Uncertainties about the benefit-risk balance of oncology medicines assessed by the European Medicines Agency.

ABSTRACT:

Background

Drug regulators assess and describe uncertainties regarding treatment outcomes and the benefit-risk balance of newly authorised medicines. We aimed to evaluate the type and number of uncertainties described in the benefit-risk assessment for initial marketing authorisations of oncology medicines assessed by the European Medicines Agency (EMA). We also aimed to develop a systematic classification of uncertainties to contribute to improved communication about uncertainties.

Materials and methods

We included all medicines containing a new active substance assessed by the EMA and granted an initial marketing authorisation by the European Commission in 2011-2022 for an oncology indication. We extracted characteristics of these oncology medicines and uncertainties descr

SUBMITTER: Taams AC 

PROVIDER: S-EPMC11696770 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature