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EU Group Facilitates Switching Multinational Trials To CTR

Second Survey Launched To Identify Remaining Hurdles To CTR Implementation

 
• By Vibha Sharma

Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution oriented.”

Macro photo of tooth wheel mechanism with PROBLEM SOLVING concept related words imprinted on metal surface
EU Regulators Want To Address Hurdles Hampering The Smooth Implementation Of CTR • Source: Shutterstock

EU member states have issued updated guidance that should make it easier for sponsors to transition certain multinational trials being conducted under the erstwhile Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR) by requiring fewer changes to support the switch.

The revised guidance, published this month, is from the Clinical Trials Coordination Group (CTCG), a working group of the EU’s Heads of Medicines Agencies (HMA) that is tasked with

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