Posted by Michael Wonder on 08 Oct 2023
Clinical studies: you can see better with the second arm
6 October 2023 - In a statement to the EMA, the IQWiG emphasised that single-arm studies may be sufficient for active ingredient approval in exceptional cases - but not for health technology assessments. They hinder improvements in care instead of accelerating them.
The IQWiG has critically commented on a reflection paper by the EMA on the market approval of new active ingredients based on single-arm studies.
