Research from IQWiG shows early benefit assessment increases trial data transparency

Research from the German Institute for Quality and Efficiency in Healthcare (IQWiG) published in the British Medical Journal has shown that early benefit assessment documentation is a tool with which to increase trial data transparency.

The German Act on the Reform of the Market for Medicinal Products (AMNOG) came in four years ago, aimed at containing the drug expenditure by statutory health insurance funds. It also stipulated an early benefit assessment of new drugs, which reveals so far unpublished information from clinical study reports. Researchers found that company dossiers and the dossier assessment performed by the IQWiG and published during early benefit assessment contain considerably more information than other publicly-available documents on clinical studies. This was especially prevalent with regards to patient-relevant outcomes in approved subpopulations.

Much greater transparency in AMNOG data