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Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making.
Schneeweiss S, Eichler HG, Garcia-Altes A, Chinn C, Eggimann AV, Garner S, Goettsch W, Lim R, Löbker W, Martin D, Müller T, Park BJ, Platt R, Priddy S, Ruhl M, Spooner A, Vannieuwenhuyse B, Willke RJ. Schneeweiss S, et al. Among authors: platt r. Clin Pharmacol Ther. 2016 Dec;100(6):633-646. doi: 10.1002/cpt.512. Epub 2016 Oct 19. Clin Pharmacol Ther. 2016. PMID: 27627027
When Can We Trust Real-World Data To Evaluate New Medical Treatments?
Simon GE, Bindman AB, Dreyer NA, Platt R, Watanabe JH, Horberg M, Hernandez A, Califf RM. Simon GE, et al. Among authors: platt r. Clin Pharmacol Ther. 2022 Jan;111(1):24-29. doi: 10.1002/cpt.2252. Epub 2021 May 28. Clin Pharmacol Ther. 2022. PMID: 33932030 Free PMC article.
When Can We Rely on Real-World Evidence to Evaluate New Medical Treatments?
Simon GE, Platt R, Watanabe JH, Bindman AB, John London A, Horberg M, Hernandez A, Califf RM. Simon GE, et al. Among authors: platt r. Clin Pharmacol Ther. 2022 Jan;111(1):30-34. doi: 10.1002/cpt.2253. Epub 2021 May 19. Clin Pharmacol Ther. 2022. PMID: 33895994 Free PMC article.
Leveraging the Capabilities of the FDA's Sentinel System To Improve Kidney Care.
Adimadhyam S, Barreto EF, Cocoros NM, Toh S, Brown JS, Maro JC, Corrigan-Curay J, Dal Pan GJ, Ball R, Martin D, Nguyen M, Platt R, Li X. Adimadhyam S, et al. Among authors: platt r. J Am Soc Nephrol. 2020 Nov;31(11):2506-2516. doi: 10.1681/ASN.2020040526. Epub 2020 Oct 19. J Am Soc Nephrol. 2020. PMID: 33077615 Free PMC article. Review.
FDA-Catalyst-Using FDA's Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial.
Cocoros NM, Pokorney SD, Haynes K, Garcia C, Al-Khalidi HR, Al-Khatib SM, Archdeacon P, Goldsack JC, Harkins T, Lin ND, Martin D, McCall D, Nair V, Parlett L, Temple R, McMahill-Walraven C, Granger CB, Platt R. Cocoros NM, et al. Among authors: platt r. Clin Trials. 2019 Feb;16(1):90-97. doi: 10.1177/1740774518812776. Epub 2018 Nov 16. Clin Trials. 2019. PMID: 30445835
1,226 results