Investigator-initiated randomized controlled trials in children with epilepsy: Mission impossible?

ABSTRACT:

Objective

In children many antiepileptic drugs (AEDs) are prescribed off-label due to a lack of well-designed randomized controlled trials (RCTs). We conducted a multicenter RCT in the Netherlands to compare levetiracetam and valproic acid as monotherapy in children with newly diagnosed epilepsy. After 2 years, we had to stop this investigator-initiated trial prematurely because the inclusion rate was too low. We analyzed the reasons for this failure, assessed the various issues involved in performing RCTs in children, and now give recommendations for future studies.

Methods

A questionnaire was completed by all investigators involved in the study. It included questions about the motivation to participate and the perceived reasons for recruitment failure. We also studied lite

SUBMITTER: Weijenberg A 

PROVIDER: S-EPMC5939385 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature