Opinion Split Over ICH Proposal To Limit Safety Data Collection

Some Feel ICH Guide Can Jeopardize Data Collection

01 Nov 2019

A draft international guideline that proposes limiting safety data collection in premarket and postmarket trials if the drug’s safety profile is sufficiently characterized has drawn a varied response from a range of stakeholders in the EU.

Clinical trials — Stakeholders Have Expressed Mixed Views On ICH’s E19 Guide • Source: Shutterstock

The International Council for Harmonisation’s draft guideline that proposes limiting the collection of safety data in some late-stage premarketing or postmarketing studies has drawn a mixed response from stakeholders in the EU.

Feedback to a public consultation on the E19 guidance ranges from the Association of Medical Ethics Committees in Germany describing...