Low-risk trials for children and pregnant women threatened by unnecessary strict regulations. Does the coming EU Clinical Trial Regulation offer a solution?

Investigator-initiated clinical trials are crucial for improving quality of care for children and pregnant women as they are often excluded from industry-initiated trials. However, trials have become increasingly time-consuming and costly since the EU Clinical Trial Directive entered into force in 2001. This directive made compliance with ICH-Good Clinical Practice Guidelines (ethical and quality standard for conducting human subject research) mandatory for all clinical trials, regardless of its risk-classification.

[Medical-ethical review of multicenter studies can be obtained faster: new directive leaves room for improvement].

Objective: To evaluate whether the speed at which multicenter studies can be launched in the Netherlands has been improved by the new External Review Directive.

Design: Cohort study.

Method: We studied the time between requesting and granting a declaration of local feasibility of 7 multicenter studies under the new External Review Directive, which came into effect on 1 March 2012.