Zhou W - 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: zhou w. 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

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: zhou w. 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.

3

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: zhou w. 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.

4

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

5

Pharmacoepidemiology: A time for a new multidisciplinary approach to precision medicine.

Issa AM, Carleton B, Gerhard T, Filipski KK, Freedman AN, Kimmel S, Liu G, Longo C, Maitland-van der Zee AH, Sansbury L, Zhou W, Bartlett G. Issa AM, et al. Among authors: zhou w. Pharmacoepidemiol Drug Saf. 2021 Aug;30(8):985-992. doi: 10.1002/pds.5226. Epub 2021 Apr 7. Pharmacoepidemiol Drug Saf. 2021. PMID: 33715268 Review.

6

Global covid-19 vaccine rollout and safety surveillance-how to keep pace.

Lo Re V 3rd, Klungel OH, Chan KA, Panozzo CA, Zhou W, Winterstein AG. Lo Re V 3rd, et al. Among authors: zhou w. BMJ. 2021 Jun 18;373:n1416. doi: 10.1136/bmj.n1416. BMJ. 2021. PMID: 34144957 No abstract available.

7

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: zhou w. 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.

8

Regulator-Requested Non-Interventional Postauthorization Safety and Effectiveness Studies for Oncology Drugs: A Systematic Review.

Zhang X, Chen L, Bracco OL, Setoguchi S, Zhou W, Burcu M. Zhang X, et al. Among authors: zhou w. Clin Pharmacol Ther. 2022 Jan;111(1):155-167. doi: 10.1002/cpt.2450. Epub 2021 Nov 2. Clin Pharmacol Ther. 2022. PMID: 34655473

9

Evaluation and Comparison of Real-World Databases for Conducting Research in Patients With Colorectal Cancer.

Wang CY, Shao C, McDonald AC, Amonkar MM, Zhou W, Bortnichak EA, Liu X. Wang CY, et al. Among authors: zhou w. JCO Clin Cancer Inform. 2023 Jul;7:e2200184. doi: 10.1200/CCI.22.00184. JCO Clin Cancer Inform. 2023. PMID: 37437227

10

Association Between Homologous Recombination Repair Biomarkers and Survival in Patients With Solid Tumors.

Shao C, Ren Y, Zhou H, Chen C, Dettman EJ, Lee LC, Cristescu R, Gozman A, Jin F, Zhou W. Shao C, et al. Among authors: zhou h, zhou w. JCO Precis Oncol. 2023 Sep;7:e2300195. doi: 10.1200/PO.23.00195. JCO Precis Oncol. 2023. PMID: 37972338

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