Pétavy F - Search Results

1

Estimation of treatment effects in short-term depression studies. An evaluation based on the ICH E9(R1) estimands framework.

Mitroiu M, Teerenstra S, Oude Rengerink K, Pétavy F, Roes KCB. Mitroiu M, et al. Among authors: petavy f. Pharm Stat. 2022 Sep;21(5):1037-1057. doi: 10.1002/pst.2214. Epub 2022 Jun 9. Pharm Stat. 2022. PMID: 35678545 Free PMC article.

2

A narrative review of estimands in drug development and regulatory evaluation: old wine in new barrels?

Mitroiu M, Oude Rengerink K, Teerenstra S, Pétavy F, Roes KCB. Mitroiu M, et al. Among authors: petavy f. Trials. 2020 Jul 23;21(1):671. doi: 10.1186/s13063-020-04546-1. Trials. 2020. PMID: 32703247 Free PMC article. Review.

3

Beyond "Intent-to-treat" and "Per protocol": Improving assessment of treatment effects in clinical trials through the specification of an estimand.

Pétavy F, Guizzaro L, Antunes Dos Reis I, Teerenstra S, Roes KCB. Pétavy F, et al. Br J Clin Pharmacol. 2020 Jul;86(7):1235-1239. doi: 10.1111/bcp.14195. Epub 2020 Mar 27. Br J Clin Pharmacol. 2020. PMID: 31883123 Free PMC article.

4

Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials.

Collignon O, Gartner C, Haidich AB, James Hemmings R, Hofner B, Pétavy F, Posch M, Rantell K, Roes K, Schiel A. Collignon O, et al. Among authors: petavy f. Clin Pharmacol Ther. 2020 May;107(5):1059-1067. doi: 10.1002/cpt.1804. Epub 2020 Apr 1. Clin Pharmacol Ther. 2020. PMID: 32017052 Review.

5

Rethinking the intention-to-treat principle: one size does not fit all.

Oude Rengerink K, Mitroiu M, Teerenstra S, Pétavy F, Roes KCB. Oude Rengerink K, et al. Among authors: petavy f. J Clin Epidemiol. 2020 Sep;125:198-200. doi: 10.1016/j.jclinepi.2020.04.023. Epub 2020 May 4. J Clin Epidemiol. 2020. PMID: 32380178 No abstract available.

6

Regulatory watch: Challenges in drug development for central nervous system disorders: a European Medicines Agency perspective.

Butlen-Ducuing F, Pétavy F, Guizzaro L, Zienowicz M, Haas M, Alteri E, Salmonson T, Corruble E. Butlen-Ducuing F, et al. Among authors: petavy f. Nat Rev Drug Discov. 2016 Nov 29;15(12):813-814. doi: 10.1038/nrd.2016.237. Nat Rev Drug Discov. 2016. PMID: 27895328 No abstract available.

7

Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency.

Collignon O, Koenig F, Koch A, Hemmings RJ, Pétavy F, Saint-Raymond A, Papaluca-Amati M, Posch M. Collignon O, et al. Among authors: petavy f. Trials. 2018 Nov 20;19(1):642. doi: 10.1186/s13063-018-3012-x. Trials. 2018. PMID: 30454061 Free PMC article.

8

EMA Review of Axicabtagene Ciloleucel (Yescarta) for the Treatment of Diffuse Large B-Cell Lymphoma.

Papadouli I, Mueller-Berghaus J, Beuneu C, Ali S, Hofner B, Petavy F, Tzogani K, Miermont A, Norga K, Kholmanskikh O, Leest T, Schuessler-Lenz M, Salmonson T, Gisselbrecht C, Garcia JL, Pignatti F. Papadouli I, et al. Among authors: petavy f. Oncologist. 2020 Oct;25(10):894-902. doi: 10.1634/theoncologist.2019-0646. Epub 2020 Apr 27. Oncologist. 2020. PMID: 32339368 Free PMC article. Review.

9

Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation.

Eichler HG, Koenig F, Arlett P, Enzmann H, Humphreys A, Pétavy F, Schwarzer-Daum B, Sepodes B, Vamvakas S, Rasi G. Eichler HG, et al. Among authors: petavy f. Clin Pharmacol Ther. 2020 Apr;107(4):773-779. doi: 10.1002/cpt.1638. Epub 2019 Oct 1. Clin Pharmacol Ther. 2020. PMID: 31574163 Free PMC article. Review.

10

Statistical considerations about the design and endpoints of randomized clinical trials for children with irritable bowel syndrome.

Collignon O, Pétavy F. Collignon O, et al. Among authors: petavy f. Neurogastroenterol Motil. 2018 May;30(5):e13266. doi: 10.1111/nmo.13266. Neurogastroenterol Motil. 2018. PMID: 29700959 No abstract available.

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