Literature DB >> 29735910

Correction: Antoniou, M.; et al. Biomarker-Guided Non-Adaptive Trial Designs in Phase II and Phase III: A Methodological Review. J. Pers. Med. 2017, 7, 1.

Miranta Antoniou1,2, Ruwanthi Kolamunnage-Dona3,4, Andrea L Jorgensen5,6.   

Abstract

Entities:  

Year:  2018        PMID: 29735910      PMCID: PMC6023546          DOI: 10.3390/jpm8020017

Source DB:  PubMed          Journal:  J Pers Med        ISSN: 2075-4426


× No keyword cloud information.
The authors wish to make the following corrections to this paper [1]: On page 26, the sentence, “If the overall test is not significant, then the experimental treatment is compared to the control treatment in the biomarker-positive patients using the type I error a = 0.05.” should be “If the overall test is not significant, then the experimental treatment is compared to the control treatment in the biomarker-positive patients using the significance level 0.05 − a.” They would also like to remove the last paragraph of page 32 due to inaccurate description of the adaptive signature design: “The same analysis plan was used in the adaptive signature design which is further described in our methodological review regarding the biomarker-guided adaptive designs, Antoniou et al., 2016 [35]. More precisely, the difference between the adaptive signature design and the fall-back design is the following: in the adaptive signature design, in case that the first stage failures to show treatment effectiveness in the entire population, then the study population is divided in order to develop and validate a biomarker, using a split sample strategy, whereas in the biomarker-positive and overall strategies design with fall-back analysis the biomarker assessment is conducted at the beginning of the trial. However, both of the designs test at the first stage the entire population at the significance level a1 and at the second stage the biomarker-positive patients at the significance level a2 = a − a1.” These changes have no material impact on the conclusions of the paper. The authors would like to apologize for any inconvenience caused to the readers by these changes.
  1 in total

Review 1.  Biomarker-Guided Non-Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.

Authors:  Miranta Antoniou; Ruwanthi Kolamunnage-Dona; Andrea L Jorgensen
Journal:  J Pers Med       Date:  2017-01-25
  1 in total
  3 in total

Review 1.  Key enablers and barriers to implementing adaptive pathways in the European setting.

Authors:  Juan Carlos Rejon-Parrilla; Pall Jonsson; Jacoline C Bouvy
Journal:  Br J Clin Pharmacol       Date:  2019-04-29       Impact factor: 4.335

2.  Time to reality check the promises of machine learning-powered precision medicine.

Authors:  Jack Wilkinson; Kellyn F Arnold; Eleanor J Murray; Maarten van Smeden; Kareem Carr; Rachel Sippy; Marc de Kamps; Andrew Beam; Stefan Konigorski; Christoph Lippert; Mark S Gilthorpe; Peter W G Tennant
Journal:  Lancet Digit Health       Date:  2020-09-16

Review 3.  Specific requirements for translation of biological research into clinical radiation oncology.

Authors:  Mechthild Krause; Jan Alsner; Annett Linge; Rebecca Bütof; Steffen Löck; Rob Bristow
Journal:  Mol Oncol       Date:  2020-04-08       Impact factor: 6.603

  3 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.