Collignon O - Search Results

1

Marketing authorisation applications submitted to the European Medicines Agency by small and medium-sized enterprises: an analysis of major objections and their impact on outcomes.

Amaouche N, Casaert Salomé H, Collignon O, Santos MR, Ziogas C. Amaouche N, et al. Among authors: collignon o. Drug Discov Today. 2018 Oct;23(10):1801-1805. doi: 10.1016/j.drudis.2018.06.018. Epub 2018 Jun 25. Drug Discov Today. 2018. PMID: 29953957 Free article. Review.

2

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. Trials. 2018 Nov 20;19(1):642. doi: 10.1186/s13063-018-3012-x. Trials. 2018. PMID: 30454061 Free PMC article.

3

Regulatory considerations on the enrollment of older adults in oncology clinical trials.

Raimi-Abraham BT, de Orbe Izquierdo MS, Collignon O, Cerreta F. Raimi-Abraham BT, et al. Among authors: collignon o. J Geriatr Oncol. 2017 May;8(3):151-153. doi: 10.1016/j.jgo.2017.02.006. Epub 2017 Mar 9. J Geriatr Oncol. 2017. PMID: 28284754 No abstract available.

4

Regulatory assessment of drug dissolution profiles comparability via maximum deviation.

Moellenhoff K, Dette H, Kotzagiorgis E, Volgushev S, Collignon O. Moellenhoff K, et al. Among authors: collignon o. Stat Med. 2018 Sep 10;37(20):2968-2981. doi: 10.1002/sim.7689. Epub 2018 Jun 3. Stat Med. 2018. PMID: 29862526

5

Implementing Historical Controls in Oncology Trials.

Collignon O, Schritz A, Spezia R, Senn SJ. Collignon O, et al. Oncologist. 2021 May;26(5):e859-e862. doi: 10.1002/onco.13696. Epub 2021 Mar 6. Oncologist. 2021. PMID: 33523511 Free PMC article.

6

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. 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.

7

Collaborative Platform Trials to Fight COVID-19: Methodological and Regulatory Considerations for a Better Societal Outcome.

Collignon O, Burman CF, Posch M, Schiel A. Collignon O, et al. Clin Pharmacol Ther. 2021 Aug;110(2):311-320. doi: 10.1002/cpt.2183. Epub 2021 Mar 16. Clin Pharmacol Ther. 2021. PMID: 33506495 Free PMC article. Review.

8

Clustered allocation as a way of understanding historical controls: Components of variation and regulatory considerations.

Collignon O, Schritz A, Senn SJ, Spezia R. Collignon O, et al. Stat Methods Med Res. 2020 Jul;29(7):1960-1971. doi: 10.1177/0962280219880213. Epub 2019 Oct 10. Stat Methods Med Res. 2020. PMID: 31599194

9

The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.

Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious SA, Mander AP, Weir CJ, Koenig F, Walton MK, Nicholl JP, Coates E, Biggs K, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG; ACE Consensus Group. Dimairo M, et al. Trials. 2020 Jun 17;21(1):528. doi: 10.1186/s13063-020-04334-x. Trials. 2020. PMID: 32546273 Free PMC article.

10

Assessment of tumour-agnostic therapies in basket trials.

Collignon O, Posch M, Schiel A. Collignon O, et al. Lancet Oncol. 2022 Jan;23(1):e8. doi: 10.1016/S1470-2045(21)00717-8. Lancet Oncol. 2022. PMID: 34973235 No abstract available.

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