Guidelines on real world data could bring cannabinoid drugs to UK patients sooner

New guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) on the use of real word data and evidence (RWD/E) to support clinical trials could help cannabinoid medicinal products gain approval in Britain.

The MHRA highlighted that RWD and RWE have been used extensively for monitoring the performance of medicines and devices after regulatory approval but they have not traditionally been used to demonstrate safety and efficacy beforehand.

Use of such data sources for this purpose in clinical studies has the potential to increase the speed and reduce the cost of development programmes.

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      New guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) on the use of real word data and evidence (RWD/E) to support clinical trials could help cannabinoid medicinal products gain approval in Britain.

      The MHRA highlighted that RWD and RWE have been used extensively for monitoring the performance of medicines and devices after regulatory approval but they have not traditionally been used to demonstrate safety and efficacy beforehand.

      Use of such data sources for this purpose in clinical studies has the potential to increase the speed and reduce the cost of development programmes.

      ...

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      Need help?

      Contact a sales representative right now and don’t wait

      Erik Galavis
      +34 654 320 547
      Email Erik

      Pablo Sharrock
      +34 722 642 678
      Email Pablo