Dreyer NA - Search Results

1

The Certainty Framework for Assessing Real-World Data in Studies of Medical Product Safety and Effectiveness.

Cocoros NM, Arlett P, Dreyer NA, Ishiguro C, Iyasu S, Sturkenboom M, Zhou W, Toh S. Cocoros NM, et al. Among authors: dreyer na. Clin Pharmacol Ther. 2021 May;109(5):1189-1196. doi: 10.1002/cpt.2045. Epub 2020 Oct 8. Clin Pharmacol Ther. 2021. PMID: 32911562

2

Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable.

Dreyer NA. Dreyer NA. Ther Innov Regul Sci. 2018 May;52(3):362-368. doi: 10.1177/2168479018763591. Epub 2018 Mar 19. Ther Innov Regul Sci. 2018. PMID: 29714575 Free PMC article.

3

Considerations in characterizing real-world data relevance and quality for regulatory purposes: A commentary.

Girman CJ, Ritchey ME, Zhou W, Dreyer NA. Girman CJ, et al. Among authors: dreyer na. Pharmacoepidemiol Drug Saf. 2019 Apr;28(4):439-442. doi: 10.1002/pds.4697. Epub 2018 Dec 5. Pharmacoepidemiol Drug Saf. 2019. PMID: 30515910 Free PMC article. No abstract available.

4

Real-world evidence to support regulatory decision-making for medicines: Considerations for external control arms.

Burcu M, Dreyer NA, Franklin JM, Blum MD, Critchlow CW, Perfetto EM, Zhou W. Burcu M, et al. Among authors: dreyer na. Pharmacoepidemiol Drug Saf. 2020 Oct;29(10):1228-1235. doi: 10.1002/pds.4975. Epub 2020 Mar 11. Pharmacoepidemiol Drug Saf. 2020. PMID: 32162381 Free PMC article.

5

Methods for external control groups for single arm trials or long-term uncontrolled extensions to randomized clinical trials.

Seeger JD, Davis KJ, Iannacone MR, Zhou W, Dreyer N, Winterstein AG, Santanello N, Gertz B, Berlin JA. Seeger JD, et al. Pharmacoepidemiol Drug Saf. 2020 Nov;29(11):1382-1392. doi: 10.1002/pds.5141. Epub 2020 Oct 4. Pharmacoepidemiol Drug Saf. 2020. PMID: 32964514 Free PMC article. Review.

6

Real-world evidence to support regulatory decision making: New or expanded medical product indications.

Franklin JM, Liaw KL, Iyasu S, Critchlow CW, Dreyer NA. Franklin JM, et al. Among authors: dreyer na. Pharmacoepidemiol Drug Saf. 2021 Jun;30(6):685-693. doi: 10.1002/pds.5222. Epub 2021 Mar 18. Pharmacoepidemiol Drug Saf. 2021. PMID: 33675248 Review.

7

When Can Nonrandomized Studies Support Valid Inference Regarding Effectiveness or Safety of New Medical Treatments?

Franklin JM, Platt R, Dreyer NA, London AJ, Simon GE, Watanabe JH, Horberg M, Hernandez A, Califf RM. Franklin JM, et al. Among authors: dreyer na. Clin Pharmacol Ther. 2022 Jan;111(1):108-115. doi: 10.1002/cpt.2255. Epub 2021 May 9. Clin Pharmacol Ther. 2022. PMID: 33826756 Free PMC article. Review.

8

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: dreyer na. 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.

9

Uncontrolled Extensions of Clinical Trials and the Use of External Controls-Scoping Opportunities and Methods.

Wang CY, Berlin JA, Gertz B, Davis K, Li J, Dreyer NA, Zhou W, Seeger JD, Santanello N, Winterstein AG. Wang CY, et al. Among authors: dreyer na. Clin Pharmacol Ther. 2022 Jan;111(1):187-199. doi: 10.1002/cpt.2346. Epub 2021 Aug 10. Clin Pharmacol Ther. 2022. PMID: 34165790 Free PMC article.

10

Angiotensin receptor blockers and angiotensin-converting enzyme inhibitors: challenges in comparative effectiveness using Medicare data.

Setoguchi S, Shrank WH, Liu J, Lee JC, Saya U, Winkelmayer WC, Dreyer NA. Setoguchi S, et al. Among authors: dreyer na. Clin Pharmacol Ther. 2011 May;89(5):674-82. doi: 10.1038/clpt.2011.17. Epub 2011 Mar 30. Clin Pharmacol Ther. 2011. PMID: 21451506 Free PMC article.

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