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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.
