Real-world evidence and product development: Opportunities, challenges and risk mitigation

Author:

Naidoo Poobalan,Bouharati CéliaORCID,Rambiritch Virendra,Jose Nadina,Karamchand Sumanth,Chilton Robert,Leisegang Rory

Publisher

Springer Science and Business Media LLC

Subject

General Medicine

Reference37 articles.

1. Wise J, Möller A, Christie D, Kalra D, Brodsky E, Georgieva E, et al. The positive impacts of Real-World Data on the challenges facing the evolution of biopharma. Drug Discov Today. 2018;23(4):788–801.

2. Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, et al. Real-world evidence—what is it and what can it tell us? N Engl J Med. 2016;375(23):2293–7.

3. US Food and Drug Administration. Framework for FDA’s real world evidence program. 2018. https://www.fda.gov/media/120060/download. Accessed 15 Oct 2020.

4. U.S. Department of Health and Human Services, Food and Drug Administration. Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics Guidance for Industry. 2019 May; https://www.fda.gov/regulatory-information/search-fdaguidance-documents/submitting-documents-using-real-world-data-and-real-world-evidence-fda-drugs-and-biologics-guidance.

5. Applied Clinical Trials. Real-world evidence studies. https://www.appliedclinicaltrialsonline.com/view/real-world-evidence-studies. Accessed 15 Oct 2020.

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