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Trial designs using real-world data: The changing landscape of the regulatory approval process.
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.
Use of Real-World Data to Emulate a Clinical Trial and Support Regulatory Decision Making: Assessing the Impact of Temporality, Comparator Choice, and Method of Adjustment.
Abrahami D, Pradhan R, Yin H, Honig P, Baumfeld Andre E, Azoulay L.
Abrahami D, et al. Among authors: baumfeld andre e.
Clin Pharmacol Ther. 2021 Feb;109(2):452-461. doi: 10.1002/cpt.2012. Epub 2020 Sep 19.
Clin Pharmacol Ther. 2021.
PMID: 32767673
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Defining Clinically Relevant Target Populations Using Real-World Data to Guide the Design of Representative Antidiabetic Drug Trials.
Pradhan R, Abrahami D, Yin H, Yu OHY, Sahasrabudhe V, Baumfeld Andre E, Azoulay L.
Pradhan R, et al. Among authors: baumfeld andre e.
Clin Pharmacol Ther. 2021 May;109(5):1219-1223. doi: 10.1002/cpt.2213. Epub 2021 Mar 16.
Clin Pharmacol Ther. 2021.
PMID: 33615445
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Application of Real-World Data to External Control Groups in Oncology Clinical Trial Drug Development.
Yap TA, Jacobs I, Baumfeld Andre E, Lee LJ, Beaupre D, Azoulay L.
Yap TA, et al. Among authors: baumfeld andre e.
Front Oncol. 2022 Jan 6;11:695936. doi: 10.3389/fonc.2021.695936. eCollection 2021.
Front Oncol. 2022.
PMID: 35070951
Free PMC article.
Review.
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Overcoming Regulatory Aversion to Novel Methods of Evidence Generation.
Baumfeld Andre E, Honig PK.
Baumfeld Andre E, et al.
Clin Pharmacol Ther. 2020 May;107(5):1057-1058. doi: 10.1002/cpt.1711. Epub 2019 Nov 30.
Clin Pharmacol Ther. 2020.
PMID: 31785161
Free PMC article.
No abstract available.
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The Current Landscape and Emerging Applications for Real-World Data in Diagnostics and Clinical Decision Support and its Impact on Regulatory Decision Making.
Baumfeld Andre E, Carrington N, Siami FS, Hiatt JC, McWilliams C, Hiller C, Surinach A, Zamorano A, Pashos CL, Schulz WL.
Baumfeld Andre E, et al.
Clin Pharmacol Ther. 2022 Dec;112(6):1172-1182. doi: 10.1002/cpt.2565. Epub 2022 Apr 29.
Clin Pharmacol Ther. 2022.
PMID: 35213741
Free PMC article.
Review.
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