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.”
Posted by Dr. Tim Sandle
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