Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Aug;43(8):464-472.

Real-World Evidence: Promise and Peril For Medical Product Evaluation

Sanket S Dhruva, Joseph S Ross, Nihar R Desai

Real-World Evidence: Promise and Peril For Medical Product Evaluation

Sanket S Dhruva et al. P T. 2018 Aug.

Abstract

Randomized controlled trials have long been the gold standard for evidence in medical product evaluation, but there is growing support for the use of real-world evidence (RWE). The authors review the benefits and limitations of RWE and discuss the implications for P&T committees.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence—what is it and what can it tell us? N Engl J Med. 2016;375(23):2293–2297. - PubMed
    1. Institute of Medicine. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: National Academies Press (US), National Academy of Sciences; 2010. The National Academies Collection: Reports funded by National Institutes of Health. - PubMed
    1. Prasad V, Mailankody S. Research and development spending to bring a single cancer drug to market and revenues after approval. JAMA Intern Med. 2017;177(11):1569–1575. - PMC - PubMed
    1. DiMasi JA, Grabowski HG, Hansen RW. Innovation in the pharmaceutical industry: New estimates of R&D costs. J Health Econ. 2016;47:20–33. - PubMed
    1. Sertkaya A, Wong HH, Jessup A, Beleche T. Key cost drivers of pharmaceutical clinical trials in the United States. Clin Trials. 2016;13(2):117–126. - PubMed

LinkOut - more resources