Analysis of RWD/RWE recommendations and guidelines for 2021. International experience on the example of USA
https://doi.org/10.37489/2782-3784-myrwd-17
EDN: WRSZFT
Abstract
The regulatory aspects of the conduction of the real-world clinical data studies became a trend in the past few years. In 2021 FDA issued three projects of such documents. The article resumes the main objectives of these FDA documents. Analysed projects of FDA recommendations represents the international expertise in this field and may be used in the process of building local regulations.
About the Author
A. Kurylev
First Saint-Petersburg State Medical University Named After Academician Pavlov; National Research Center of Oncology named after N. N. Petrov
Russian Federation
Competing Interests:
Russian Federation
Kurylev Alexey A. — Cand. Sci. Med., Assistant of professor Department of Clinical Pharmacology and Evidence-Based Medicine
Saint-Petersburg
Competing Interests:
The authors declare no conflict of interest.
References
1. Real-World Data:Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry. DRAFT GUIDANCE. https://www.regulations.gov/document/FDA-2020-D-2307-0002.
2. Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry.DRAFTGUIDANCE. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-registries-support-regulatory-decision-making-drug-and-biological-products?utm_medium=email&utm_source=govdelivery.
3. Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry. DRAFT GUIDANCE. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drug.
4. Best Practices for Conducting and Reporting Pharma- coepidemiologic Safety Studies Using Electronic Healthcare Data Sets. https://www.fda.gov/media/79922/download.
Review
For citations:
Kurylev A. Analysis of RWD/RWE recommendations and guidelines for 2021. International experience on the example of USA. Real-World Data & Evidence. 2022;2(3):1-6. (In Russ.) https://doi.org/10.37489/2782-3784-myrwd-17. EDN: WRSZFT
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