Real-world evidence: the devil is in the detail

Author:

Gokhale Mugdha,Stürmer Til,Buse John B.

Funder

Biostatistics, Epidemiology, and Research Design (BERD), North Carolina Translational and Clinical Sciences Institute

National Institute on Aging

NIH

Publisher

Springer Science and Business Media LLC

Subject

Endocrinology, Diabetes and Metabolism,Internal Medicine

Reference99 articles.

1. Wedam S, Fashoyin-Aje L, Bloomquist E et al (2020) FDA approval summary: palbociclib for male patients with metastatic breast cancer. Clin Cancer Res 26(6):1208–1212. https://doi.org/10.1158/1078-0432.CCR-19-2580

2. U.S. FDA (2019) Webinar: framework for FDA’s Real-World Evidence Program – Mar 15, 2019. Available from https://www.fda.gov/drugs/webinar-framework-fdas-real-world-evidence-program-mar-15-2019. Accessed 20 Dec 2019

3. U.S. FDA (2019) Submitting documents using real-world data and real-world evidence to FDA for drugs and biologics guidance for industry - May 9, 2019. Available from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-documents-using-real-world-data-and-real-world-evidence-fda-drugs-and-biologics-guidance. Accessed 20 Dec 2019

4. Allie Nawrat, Pharma Technology Focus (2019) Real world data - how can it improve clinical trial outcomes. Available from https://www.pharmaceutical-technology.com/features/real-world-data-improving-outcomes/. Accessed 20 Dec 2019

5. Hernan MA (2018) The C-word: scientific euphemisms do not improve causal inference from observational data. Am J Public Health 108(5):616–619. https://doi.org/10.2105/AJPH.2018.304337

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