Following the recent stakeholder meeting on the transparency addendum for the EU portal and EU database, which took place at the EMA on 01 June 2015, the Exploratory Medicines Development (EUFEMED) and the European CRO Federation (EUCROF) have made a joint submission to the European Medicines Agency (EMA) on the timelines for publication of summary results for trials without therapeutic or prophylactic intent (“Category 1 trials”).
Please find below submission as sent to the EMA earlier today;
EUFEMED EUCROF letter to EMA 15 Jun 2015
EUFEMED survey on publication of clinical trial results final report 10-06-2015
EUCROF Position Paper Public Access to Early Phase EU database information 31 OCT 2014