Zobrazeno 1 - 10
of 12
pro vyhledávání: '"Franz Koenig"'
Autor:
Marta Bofill Roig, Pavla Krotka, Carl-Fredrik Burman, Ekkehard Glimm, Stefan M. Gold, Katharina Hees, Peter Jacko, Franz Koenig, Dominic Magirr, Peter Mesenbrink, Kert Viele, Martin Posch
Publikováno v:
BMC Medical Research Methodology. 22
BackgroundPlatform trials can evaluate the efficacy of several experimental treatments compared to a control. The number of experimental treatments is not fixed, as arms may be added or removed as the trial progresses. Platform trials are more effici
Publikováno v:
British Journal of Clinical Pharmacology
Aim In 2006, Omnitrope (by Sandoz) was the first approved biosimilar in Europe. To date, 21 biosimilars for seven different biologics are on the market. In this paper, the clinical trials undertaken to get market authorisation are compared. Methods W
Publikováno v:
Statistical methods in medical research. 29(6)
In rare diseases, fully powered large trials may not be doable in a reasonable time frame even with international collaborations. In a previous work, we proposed an approach based on a series of smaller parallel group two-arm randomised controlled tr
Autor:
Frank Pétavy, Franz Koenig, Marisa Papaluca-Amati, Martin Posch, Agnes Saint-Raymond, Olivier Collignon, Armin Koch, Robert Hemmings
Publikováno v:
Trials, Vol 19, Iss 1, Pp 1-14 (2018)
Trials
Trials
Background In recent years, experience on the application of adaptive designs in confirmatory clinical trials has accumulated. Although planning such trials comes at the cost of additional operational complexity, adaptive designs offer the benefit of
Publikováno v:
PLoS ONE, Vol 12, Iss 6, p e0180131 (2017)
PLoS ONE
PLoS ONE
In phase II platform trials, 'many-to-one' comparisons are performed when K experimental treatments are compared with a common control to identify the most promising treatment(s) to be selected for Phase III trials. However, when sample sizes are lim
Publikováno v:
Statistics in Medicine. 28:1181-1217
Adaptive designs play an increasingly important role in clinical drug development. Such designs use accumulating data of an ongoing trial to decide how to modify design aspects without undermining the validity and integrity of the trial. Adaptive des
Autor:
Amelie, Elsäßer, Jan, Regnstrom, Thorsten, Vetter, Franz, Koenig, Robert James, Hemmings, Martina, Greco, Marisa, Papaluca-Amati, Martin, Posch
Publikováno v:
Trials
Background Since the first methodological publications on adaptive study design approaches in the 1990s, the application of these approaches in drug development has raised increasing interest among academia, industry and regulators. The European Medi
Publikováno v:
Biometrical Journal. Biometrische Zeitschrift
Sample size modifications in the interim analyses of an adaptive design can inflate the type 1 error rate, if test statistics and critical boundaries are used in the final analysis as if no modification had been made. While this is already true for d
Publikováno v:
Statistics in medicine. 28(9)
It is common for a number of potentially effective treatments to be available for clinical evaluation. Limitations on resources mean that this inevitably leads to a decision as to how many, and which, treatments should be considered for inclusion in
Publikováno v:
Statistics in Medicine.
We consider the situation where in a first stage of a clinical trial several treatments are compared with a single control and the 'best' treatment(s) are selected in an interim analysis to be carried on to the second stage. We quantify the mean bias