Clinical trials in pediatric ALS : a TRICALS feasibility study

Background: Pediatric investigation plans (PIPs) describe how adult drugs can be studied in children. In 2015, PIPs for Amyotrophic Lateral Sclerosis (ALS) became mandatory for European marketing-authorization of adult treatments, unless a waiver is granted by the European Medicines Agency (EMA). Ob...

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Hauptverfasser:	Kliest, T, Van Eijk, RPA, Al-Chalabi, A, Albanese, A, Andersen, PM, Amador, MDM, BrÅthen, G, Brunaud-Danel, V, Brylev, L, Camu, W, De Carvalho, M, Cereda, C, Cetin, H, Chaverri, D, Chiò, A, Corcia, P, Couratier, P, De Marchi, F, Desnuelle, C, Van Es, MA, Esteban, J, Filosto, M, GarcÍa Redondo, A, Grosskreutz, J, Hanemann, CO, HolmØy, T, HØyer, H, Ingre, C, Koritnik, B, Kuzma-Kozakiewicz, M, Lambert, T, Leigh, PN, Lunetta, C, Mandrioli, J, Mcdermott, CJ, Meyer, T, Mora, JS, Petri, S, Povedano, M, Reviers, E, Riva, N, Roes, KCB, Rubio, MÁ, Salachas, F, Sarafov, S, SorarÙ, G, Stevic, Z, Svenstrup, K, MØller, AT, Turner, MR, Van Damme, P, Van Leeuwen, LAG, Varona, L, VÁzquez Costa, JF, Weber, M, Hardiman, O, Van Den Berg, LH
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Sprache:	eng
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Zusammenfassung:	Background: Pediatric investigation plans (PIPs) describe how adult drugs can be studied in children. In 2015, PIPs for Amyotrophic Lateral Sclerosis (ALS) became mandatory for European marketing-authorization of adult treatments, unless a waiver is granted by the European Medicines Agency (EMA). Objective: To assess the feasibility of clinical studies on the effect of therapy in children (
DOI:	10.1080/21678421.2021.2024856