Real-world evidence generation from patients, their caregivers and physicians supporting clinical, regulatory and guideline decisions: an update on Disease Specific Programmes

Author:

Anderson Peter1ORCID,Higgins Victoria1ORCID,Courcy Jonathan de1ORCID,Doslikova Katerina1ORCID,Davis Victoria A.1ORCID,Karavali Maria1ORCID,Piercy James1ORCID

Affiliation:

1. Adelphi Real World, Bollington, United Kingdom

Publisher

Informa UK Limited

Subject

General Medicine

Reference70 articles.

1. Food and Drug Administration (FDA). Real-world evidence. 2023 [cited 26 October 2023]; Available from: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence.

2. National Institute for Health and Care Excellence (NICE). NICE real-world evidence framework. 2022 [cited April 2023]; Available from: https://www.nice.org.uk/corporate/ecd9/chapter/introduction-to-real-world-evidence-in-nice-decision-making.

3. Food and Drug Administration (FDA). Framework for FDA’s Real-World Evidence Program. 2018 [cited June 2020]; Available from: https://www.fda.gov/media/120060/download.

4. Food and Drug Administration (FDA). Use of electronic health record data in clinical investigations guidance for industry. 2018 [cited June 2020]; Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-health-record-data-clinical-investigations-guidance-industry.

5. Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records

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