Jaki, Thomas and Burdon, Abigail and Chen, Xijin and Mozgunov, Pavel and Zheng, Haiyan and Baird, Richard (2023) Original Research Early phase clinical trials in oncology: Realising the potential of seamless designs. EUROPEAN JOURNAL OF CANCER, 189: 112916. ISSN 0959-8049, 1879-0852
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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/).
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CONTINUAL REASSESSMENT METHOD; POSTMENOPAUSAL WOMEN; PRACTICAL DESIGN; FULVESTRANT; CANCER; DRUG; ANASTROZOLE; ATTRITION; EFFICACY; Efficient trials; Model-based designs; Dose-determination |
| Subjects: | 000 Computer science, information & general works > 004 Computer science |
| Divisions: | Informatics and Data Science |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 31 Jan 2024 07:00 |
| Last Modified: | 31 Jan 2024 07:00 |
| URI: | https://pred.uni-regensburg.de/id/eprint/59895 |
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