ArticleEuropean journal of cancer (Oxford, England : 1990)2023
Early phase clinical trials in oncology: Realising the potential of seamless designs.
Article in European journal of cancer (Oxford, England : 1990), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed.
- An evaluation of designs for Phase I/IIa dose-finding studies in Tuberculosis.Statistical methods in medical research · 2026Article
- DOSET: dose optimization with simultaneous efficacy and toxicity evaluation, motivated by a first-in-human phase I CAR T lymphoma trial.ESMO open · 2026Article
- PRO-ADD: Patient-empowered dose-finding trials integrating safety, preliminary efficacy and patient-reported outcomes for optimal dose selection.Statistical methods in medical research · 2026Article
- Information borrowing in phase II randomized dose-ranging clinical trials in oncology.BMC medical research methodology · 2026Article
- A clinical decision framework for redox-adapted, EMT-high cancers: From ferroptosis resistance to precision therapeutic stratification.Redox biology · 2026Review
- Demographic Trends in NCI-sponsored Early-phase Clinical Trials (2000-2023): A Cohort Study.Cancer discovery · 2025Article
- Estimands for Early-Phase Dose Optimization Trials in Oncology.Biometrical journal. Biometrische Zeitschrift · 2025Article
- Using circulating tumor DNA as a novel biomarker of efficacy for dose-finding designs in oncology.Statistical methods in medical research · 2025Article
- Prevalence of symptomatic toxicities for novel therapies in adult oncology trials: a scoping review.JNCI cancer spectrum · 2025Article
- Design of a Phase I Drug Combination Study with Adaptive Allocation Based on Dose-Limiting Toxicity Attribution.Cancers · 2025Article
- Seamless trials in oncology: A cross-sectional analysis of characteristics and reporting.PloS one · 2024Article
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
backgroundThe 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.
methodsOne 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.
resultsIn 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.