Ontology highlight
ABSTRACT:
SUBMITTER: Vreman RA
PROVIDER: S-EPMC7484915 | biostudies-literature | 2020 Aug
REPOSITORIES: biostudies-literature
Clinical pharmacology and therapeutics 20200420 2
Assessments of clinical evidence vary between regulators and health technology assessment bodies, but precise differences remain unclear. To compare uncertainties raised on the clinical evidence of approved drugs, we analyzed assessments of regulators and health technology assessment (HTA) bodies in the United States and Europe. We found that US and European regulators report uncertainties related to safety for almost all drugs (85-94%), whereas HTA bodies reported these less (53-59%). By contra ...[more]