Can Weight of Evidence, Quantitative Bias, and Bounding Methods Evaluate Robustness of Real-world Evidence for Regulator and Health Technology Assessment Decisions on Medical Interventions?

Author:

Rosen Emma M.ORCID,Ritchey Mary E.,Girman Cynthia J.ORCID

Funder

Center for Truth in Science

Publisher

Elsevier BV

Subject

Pharmacology (medical),Pharmacology

Reference56 articles.

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2. FDA-authorized mRNA COVID-19 vaccines are effective per real-world evidence synthesized across a multi-state health system;Pawlowski;Med,2021

3. Guidance for Industry. Real-world data: assessing electronic health records and medical claims data to support regulatory decision-making for drug and biological products [Internet]. US Department of Health and Human Services, Food and Drug Administration; 2022 May p. pds.5444. Available from: https://onlinelibrary.wiley.com/doi/10.1002/pds.5444.

4. Where are we 10 years after the Women’s Health Initiative?;Lobo;Journal of  Clinical Endocrinol Metabolism,2013

5. A critique of the Women's Health Initiative hormone therapy study;Klaiber;Fertil Steril,2005

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