EU Group Facilitates Switching Multinational Trials To CTR
Second Survey Launched To Identify Remaining Hurdles To CTR Implementation
Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution oriented.”
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EU regulators are to speed up their evaluation of applications to transition ongoing multinational studies to the CTR.
A survey undertaken last year on the implementation of the EU Clinical Trials Regulation drew some positive feedback from study sponsors but also threw light on well-known concerns with the legislation. Some of the highlighted issues are being addressed on a priority basis.
A senior EMA official says Europe has set the ball rolling on presenting a unified approach on clinical trial processes and strategic matters, and is taking steps to ensure there are no roadblocks.