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Jaki, Thomas ; Burdon, Abigail ; Chen, Xijin ; Mozgunov, Pavel ; Zheng, Haiyan ; Baird, Richard

Early phase clinical trials in oncology: Realising the potential of seamless designs

Jaki, Thomas , Burdon, Abigail , Chen, Xijin , Mozgunov, Pavel, Zheng, Haiyan und Baird, Richard (2023) Early phase clinical trials in oncology: Realising the potential of seamless designs. European Journal of Cancer 189, S. 112916.

Veröffentlichungsdatum dieses Volltextes: 18 Mrz 2025 10:04
Artikel
DOI zum Zitieren dieses Dokuments: 10.5283/epub.75717


Zusammenfassung

Background: The pharmaceutical industry's productivity has been declining over the last two decades and high attrition rates and reduced regulatory approvals are being seen. The development of oncology drugs is particularly challenging with low rates of approval for novel treatments when compared with other therapeutic areas. Reliably establishing the potential of novel treatment and the ...

Background: The pharmaceutical industry's productivity has been declining over the last two decades and high attrition rates and reduced regulatory approvals are being seen. The development of oncology drugs is particularly challenging with low rates of approval for novel treatments when compared with other therapeutic areas. Reliably establishing the potential of novel treatment and the corresponding optimal dosage is a key component to ensure efficient overall development. A growing interest lies in terminating developments of poor treatments quickly while enabling accelerated development for highly promising interventions. Methods: One approach to reliably establish the optimal dosage and the potential of a novel treatment and thereby improve efficiency in the drug development pathway is the use of novel statistical designs that make efficient use of the data collected. Results: In this paper, we discuss different (seamless) strategies for early oncology development and illustrate their strengths and weaknesses through real trial examples. We provide some directions for good practices in early oncology development, discuss frequently seen missed opportunities for improved efficiency and some future opportunities that have yet to fully develop their potential in early oncology treatment development. Discussion: Modern methods for dose-finding have the potential to shorten and improve dose-finding and only small changes to current approaches are required to realise this potential. (c) 2023 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).



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Details

DokumentenartArtikel
Titel eines Journals oder einer ZeitschriftEuropean Journal of Cancer
Verlag:Elsevier
Ort der Veröffentlichung:OXFORD
Band:189
Seitenbereich:S. 112916
Datum13 Mai 2023
InstitutionenInformatik und Data Science
Identifikationsnummer
WertTyp
10.1016/j.ejca.2023.05.005DOI
Stichwörter / KeywordsCONTINUAL REASSESSMENT METHOD; POSTMENOPAUSAL WOMEN; PRACTICAL DESIGN; FULVESTRANT; CANCER; DRUG; ANASTROZOLE; ATTRITION; EFFICACY; Efficient trials; Model-based designs; Dose-determination
Dewey-Dezimal-Klassifikation000 Informatik, Informationswissenschaft, allgemeine Werke > 004 Informatik
StatusVeröffentlicht
BegutachtetJa, diese Version wurde begutachtet
An der Universität Regensburg entstandenZum Teil
URN der UB Regensburgurn:nbn:de:bvb:355-epub-757172
Dokumenten-ID75717

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