Friday, 2 September 2016

EMA to Revise First-in-Human Trials Guidance


Based on the recent death in a Phase I trial in France, the EMA is seeking to revise guidance to improve risk-based strategies.

In relation to this Applied Clinical Trials have an interesting article on the subject. Here is an extract:

“As Brussels sinks further into slumberous summertime mode, answers are still awaited as to how the promises of Health Technology Assessment (HTA) are to be realized in Europe. The subject is on everyone lips: it was highlighted by the June meeting of European Union health ministers as a priority, national HTA authorities endorsed a European agenda stretching to 2020 in May, the European Commission's work program for this year includes a still-to-be-seen HTA initiative, and a renewed HTA support network is due to kick into action any day now. Meanwhile, HTA bodies are increasingly present in discussions of marketing authorizations at the European Medicines Agency and elsewhere.

But what in concrete terms can be expected over the coming months? The health council conclusions underlined HTA's importance as a "tool in achieving sustainable health care systems and to promote innovation that delivers better outcomes for patients and society." The meeting acknowledged "the potential added value of health technology assessments in the context of national health systems," and invited member states to exchange methodologies and assessment outcomes, and to explore closer voluntary cooperation on HTA.”

To access the article see: ACT

Posted by Dr. Tim Sandle