Dreyer N - Search Results

1

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. Among authors: dreyer n. 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.

2

Validity of claims-based definitions of left ventricular systolic dysfunction in Medicare patients.

Li Q, Glynn RJ, Dreyer NA, Liu J, Mogun H, Setoguchi S. Li Q, et al. Pharmacoepidemiol Drug Saf. 2011 Jul;20(7):700-8. doi: 10.1002/pds.2146. Epub 2011 May 14. Pharmacoepidemiol Drug Saf. 2011. PMID: 21608070

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. 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

Trial designs using real-world data: The changing landscape of the regulatory approval process.

Baumfeld Andre E, Reynolds R, Caubel P, Azoulay L, Dreyer NA. Baumfeld Andre E, et al. Pharmacoepidemiol Drug Saf. 2020 Oct;29(10):1201-1212. doi: 10.1002/pds.4932. Epub 2019 Dec 10. Pharmacoepidemiol Drug Saf. 2020. PMID: 31823482 Free PMC article. Review.

5

Masking in Pragmatic Trials: Who, What, and When to Blind.

Christian JB, Brouwer ES, Girman CJ, Bennett D, Davis KJ, Dreyer NA. Christian JB, et al. Ther Innov Regul Sci. 2020 Mar;54(2):431-436. doi: 10.1007/s43441-019-00073-7. Epub 2020 Jan 8. Ther Innov Regul Sci. 2020. PMID: 32072597

6

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. 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.

7

Considerations when evaluating real-world data quality in the context of fitness for purpose.

Reynolds MW, Bourke A, Dreyer NA. Reynolds MW, et al. Pharmacoepidemiol Drug Saf. 2020 Oct;29(10):1316-1318. doi: 10.1002/pds.5010. Epub 2020 May 6. Pharmacoepidemiol Drug Saf. 2020. PMID: 32374042 Free PMC article. No abstract available.

8

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. Clin Pharmacol Ther. 2021 May;109(5):1189-1196. doi: 10.1002/cpt.2045. Epub 2020 Oct 8. Clin Pharmacol Ther. 2021. PMID: 32911562

9

Replication of randomized clinical trial results using real-world data: paving the way for effectiveness decisions.

Sheffield KM, Dreyer NA, Murray JF, Faries DE, Klopchin MN. Sheffield KM, et al. Among authors: dreyer na. J Comp Eff Res. 2020 Oct;9(15):1043-1050. doi: 10.2217/cer-2020-0161. Epub 2020 Sep 11. J Comp Eff Res. 2020. PMID: 32914653 Free article. Clinical Trial.

10

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. 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.

Save citations to file

Email citations

Send citations to clipboard

Add to Collections

Add to My Bibliography

Create a file for external citation management software

Your saved search

Your RSS Feed

My Custom Filters

Publication date

Text availability

Article attribute

Article type

Article Language

Species

Sex

Age

Other

179 results

Search Page

Filters