MHRA completed consultation on real-world evidence
22 March 2022
- Guidance issued for Sponsors planning to conduct clinical research to support regulatory decisions
- Use of RWE has the potential for increasing the speed and reducing the cost of development programmes, which would see effective medications being approved more quickly
- The MHRA encourages Sponsors to explore the opportunities presented by the utilisation of RWE
- RWE just as valuable for regulatory decision making as evidence from conventional RCTs, provided the data quality is robust and the trial well designed
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SVMPharma is an innovative strategic consultancy and CRO, with a focus in Real World Evidence (RWE) for pharmaceutical and biotechnology companies. SVMPharma delivers clinical trials within UK and Europe.
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For more information, please visit www.svmpharma.com and contact us at firstname.lastname@example.org