1. Medicines and Healthcare Products Regulatory Agency. MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions. GOV.UK [accessed 2022 Nov 21]. Available from: https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions
2. US Food and Drug Administration. Framework for FDA’s real-world evidence program; 2018 [accessed 2022 Nov 21]. Available from: https://www.fda.gov/media/120060/download
3. Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe
4. National Institute for Health and Care Excellence. NICE real-world evidence framework; corporate document [ECD9]; 2022 [accessed 2022 Nov 21]. Available from: https://www.nice.org.uk/corporate/ecd9/chapter/overview
5. Trial designs using real‐world data: The changing landscape of the regulatory approval process