Questionable Industry-Sponsored Postneonatal Pediatric Studies in Slovenia.

ABSTRACT:

Background

US and EU pediatric laws promote industry-sponsored pediatric studies, based on the therapeutic orphans concept that claims discrimination of children in drug treatment and drug development.

Objective

We investigated the medical validity of international pediatric studies with centers in Slovenia, an EU member state, and challenge their medical utility.

Methods

We analyzed international industry-sponsored pediatric studies with centers in Slovenia, listed in www.ClinicalTrials.gov, for their medical value.

Results

Most pediatric studies triggered by the US Food and Drug Administration and by the European Medicines Agency were/are without medical or scientific value. They were/are formally and regulatorily justified, but lack medical sense and thus we

SUBMITTER: Rose K 

PROVIDER: S-EPMC6677645 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature