Adherence to EMA scientific advice on trial design results in higher success rates, shorter overall assessment time and fewer major objections during assessment

The majority of clinical development plans submitted for scientific advice to the European Medicines Agency (EMA) prior to a marketing authorisation application were found not suitable for future benefit-risk assessment. Companies that changed their clinical development plans in accordance with the recommendation from EMA were more likely to be granted a marketing authorisation.

These are the main findings of an analysis of marketing authorisation application outcomes between 2008 and 2012 conducted by staff members of EMA and its Scientific Advice Working Party and published in Nature Reviews Drug Discovery.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/04/news_detail_002308.jsp&mid=WC0b01ac058004d5c1