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EU Extends Pilot On Using Raw Data In Medicines Reviews ‘Until Further Notice’

 
• By Eliza Slawther

EU regulators have recommended extending a pilot on the use of raw clinical trial data in medicines evaluations after an interim review of the initiative found that using such data improved regulatory decision-making.

Business, Technology, Internet and network concept. Young businessman working on a virtual screen of the future and sees the inscription: Clinical trial
Current DCT digital platforms have limited functionality and technical capabilities • Source: Shutterstock

The European Medicines Agency and EU Heads of Medicines Agencies have published interim results from a proof-of-concept pilot investigating the benefits of using raw data from clinical trials in regulatory procedures.

In the 18 October report, the EMA and HMA said that a survey of pilot participants revealed the value of performing a statistical analysis of clinical study data was “greatest for more complex

Key Takeaways
  • An EU pilot scheme focused on enhancing the use of raw data from clinical trials in the regulatory process has been extended.
  • A report has revealed positive outcomes from the pilot, and identified areas for further exploration in the next phase of the initiative

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