ACRO Urges FDA to Include E-Consent in ICH Pediatric Clinical Trials Guideline

International guidance on pediatric drug development should include provisions for remote electronic consent, and should clarify the information provided to patients prior to their enrollment in clinical trials, according to the Association of Clinical Research Organizations.

In comments on a proposed revision of the International Council for Harmonisation’s E11 guideline, ACRO called for stronger guidance advising sponsors to make clear any deviations from standards of care, especially if a trial involves a very different treatment pathway.

The association also cautioned drugmakers against using placebo-controlled trials, saying those trials are usually not accepted by regulators, and that all subjects should be treated with an active drug.