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Europe’s Two-headed Monster: Divergent Demands For Comparators Squeeze Rx Trials

 
• By Faraz Kermani

Medicines agencies and HTA bodies often ask for different clinical trials, and industry has become concerned that additional studies will cost too much and delay market access.

The European pharmaceutical industry supports closer co-operation between European medicines agencies and health technology assessment bodies as a means of avoiding the duplication of assessments. The lack of agreement among these regulatory bodies on appropriate comparators for drugs under assessment could lead to an explosion in the number and cost of clinical trials, which could eventually make them unfeasible to carry out.

Industry often struggles to identify the right comparators when facing regulatory as well as pricing approval. A medicines agency settles...

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