Regulators Can Add Value to Novel Treatments Through “Evidence by Design”

Regulators can help in the assessment of added therapeutic benefit of novel therapies by explicit reasoning and “evidence by design” say officials.

This is the conclusion drawn by European Medicines Agency (EMA) Senior Medical Officer, Hans-Georg Eichler, Harald Enzmann, Chair of the Human Medicines Committee (CHMP) and Guido Rasi, Head of European and International Affairs at the Federal Institute for Drugs and Medical Devices (BfArM).

The authors suggest that regulators can help health technology assessment (HTA) bodies, payers, clinicians and patients by providing them with a clearer reasoning on a medicine’s added benefit when compared with other therapies.

More importantly the article’s main conclusion draws that “evidence by design” is the best approach to support the assessment of added therapeutic benefit of novel treatments.The authors state that “evidence by design” can be achieved by:

“mutual understanding among all relevant decision-makers on clinical trial designs, with a view to using the entire spectrum of methodologies, including MTCs, not only head-to-head comparisons.”

The full article can be found here.

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Published 12. April 2019 in News, News EU