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A framework for assessing the impact of accelerated approval.
Gould AL, Campbell RK, Loewy JW, Beckman RA, Dey J, Schiel A, Burman CF, Zhou J, Antonijevic Z, Miller ER, Tang R. Gould AL, et al. Among authors: schiel a. PLoS One. 2022 Jun 24;17(6):e0265712. doi: 10.1371/journal.pone.0265712. eCollection 2022. PLoS One. 2022. PMID: 35749431 Free PMC article.
Estimands and Complex Innovative Designs.
Collignon O, Schiel A, Burman CF, Rufibach K, Posch M, Bretz F. Collignon O, et al. Among authors: schiel a. Clin Pharmacol Ther. 2022 Dec;112(6):1183-1190. doi: 10.1002/cpt.2575. Epub 2022 Mar 29. Clin Pharmacol Ther. 2022. PMID: 35253205 Free PMC article. Review.
The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.
Tafuri G, Lucas I, Estevão S, Moseley J, d'Andon A, Bruehl H, Gajraj E, Garcia S, Hedberg N, Massari M, Molina A, Obach M, Osipenko L, Petavy F, Petschulies M, Pontes C, Russo P, Schiel A, Van de Casteele M, Zebedin-Brandl EM, Rasi G, Vamvakas S. Tafuri G, et al. Among authors: schiel a. Br J Clin Pharmacol. 2018 May;84(5):1013-1019. doi: 10.1111/bcp.13524. Epub 2018 Mar 5. Br J Clin Pharmacol. 2018. PMID: 29370449 Free PMC article.
Assessment of tumour-agnostic therapies in basket trials.
Collignon O, Posch M, Schiel A. Collignon O, et al. Among authors: schiel a. Lancet Oncol. 2022 Jan;23(1):e8. doi: 10.1016/S1470-2045(21)00717-8. Lancet Oncol. 2022. PMID: 34973235 No abstract available.
45 results