MHRA completed consultation on real-world evidence in December 2020

• 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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About SVMPharma

SVMPharma is an innovative strategic consultancy, specialising in Real-World Evidence (RWE) for the pharmaceutical industry. SVMPharma generates RWE within UK and Europe through bespoke online Real-World Treatment Evaluators, leading to successful health technology appraisal (HTA) submissions. Clinical trial programmes do not reflect real-world clinical practice and outcomes, RWE supplements and enhances clinical datasets. SVMPharma’s specialist teams focus on delivering the outcomes that matter to your brand.

For more information, please visit www.svmpharma.com and contact us at enquiry@svmpharma.com

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