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

Autor: Miranta Antoniou, Andrea L Jorgensen, Ruwanthi Kolamunnage-Dona

Publikováno v: PLoS ONE, Vol 11, Iss 2, p e0149803 (2016)

BackgroundPersonalized medicine is a growing area of research which aims to tailor the treatment given to a patient according to one or more personal characteristics. These characteristics can be demographic such as age or gender, or biological such

Externí odkaz: https://doaj.org/article/6dcc42a962774c87853d81dd7ca27053

A RESPONSE TO 'THE POTENTIAL LONG-TERM COMPARATIVE EFFECTIVENESS OF LAROTRECTINIB AND ENTRECTINIB FOR SECOND-LINE TREATMENT OF TRK FUSION-POSITIVE METASTATIC LUNG CANCER'

Autor: Clarissa Emy Higuchi Zerbini, Sarika Ogale, Romain Freund, Miranta Antoniou

Publikováno v: Journal of managed carespecialty pharmacy. 26(12)

DISCLOSURES: The writing of this letter was sponsored by Roche/Genentech. All authors are employees of, and hold stocks in, F. Hoffmann-La Roche Ltd/Genentech Inc.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5de213fb34d21804a73abb4b99fed228
https://pubmed.ncbi.nlm.nih.gov/33251990

Biomarker-guided trials: Challenges in practice

Autor: C Billingham, Andrea L. Jorgensen, Judith M Bliss, Alexa Gillman, LC Brown, Miranta Antoniou, R Bathia, J Wason, J Paul, Ruwanthi Kolamunnage-Dona

Publikováno v: Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications, Vol 16, Iss, Pp-(2019)

Biomarker-guided trials have drawn considerable attention as they promise to lead to improvements in the benefit-risk ratio of treatments and enhanced opportunities for drug development. A variety of such designs have been proposed in the literature,

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::65ac18b54b83e63a24ffb2b53241d995
http://europepmc.org/articles/PMC6879976

Fixed and Adaptive Parallel Subgroup-Specific Design for Survival Outcomes: Power and Sample Size

Autor: Andrea L. Jorgensen, Miranta Antoniou, Ruwanthi Kolamunnage-Dona

Publikováno v: Journal of Personalized Medicine
JOURNAL OF PERSONALIZED MEDICINE
Journal of Personalized Medicine; Volume 7; Issue 4; Pages: 19
Journal of Personalized Medicine, Vol 7, Iss 4, p 19 (2017)

Biomarker-guided clinical trial designs, which focus on testing the effectiveness of a biomarker-guided approach to treatment in improving patient health, have drawn considerable attention in the era of stratified medicine with many different designs

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8e5abd33a11cde4fb51c45af9e5f9044
https://pubmed.ncbi.nlm.nih.gov/29735935

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

Autor: Andrea L. Jorgensen, Miranta Antoniou, Ruwanthi Kolamunnage-Dona

Publikováno v: Journal of Personalized Medicine, Vol 8, Iss 2, p 17 (2018)

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Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::10d246cc59a9f17cc1a79238297838ed
https://doi.org/10.3390/jpm8020017