ReviewJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014
Adaptive dose-finding studies: a review of model-guided phase I clinical trials.
Review in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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
58 citing papers in PubMed.
- Early Intravenous Beta-Blockade with Esmolol in Adults with Severe Traumatic Brain Injury: A Phase 2a Intervention Design Study.Neurocritical care · 2024Trial
- Statistical controversies in clinical research: early-phase adaptive design for combination immunotherapies.Annals of oncology : official journal of the European Society for Medical Oncology · 2017Trial
- A Phase I/II adaptive design to determine the optimal treatment regimen from a set of combination immunotherapies in high-risk melanoma.Contemporary clinical trials · 2015Trial
- A short review of dose-finding adaptive trial designs for clinical pharmacologists and non-statisticians in oncology.European journal of clinical pharmacology · 2026Review
- From Microbial Switches to Metabolic Sensors: Rewiring the Gut-Brain Kynurenine Circuit.Biomedicines · 2025Review
- Posterior Predictive Design for Phase I Clinical Trials.Journal of the American Statistical Association · 2025Article
- Design of a Phase I Drug Combination Study with Adaptive Allocation Based on Dose-Limiting Toxicity Attribution.Cancers · 2025Article
- Toxicity Adaptive Lists Design: A Practical Design for Phase I Drug Combination Trials in Oncology.JCO precision oncology · 2024Article
- Early Intravenous Beta-Blockade with Esmolol in Adults with Severe Traumatic Brain Injury (EBB-TBI): Protocol for a Phase 2a Intervention Design Study.Neurocritical care · 2024Article
- A new function for drug combination dose finding trials.Scientific reports · 2024Article
- The Future Glioblastoma Clinical Trials Landscape: Early Phase 0, Window of Opportunity, and Adaptive Phase I-III Studies.Current oncology reports · 2023Review
- Application of the patient-reported outcomes continual reassessment method to a phase I study of radiotherapy in endometrial cancer.The international journal of biostatistics · 2023Article
- Ethics and Clinical Research: Improving Transparency and Informed Consent in Phase I Oncology Trials.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Article
- Article
- Concurrent dose-finding of a novel cancer drug with and without a second agent.Journal of clinical and translational science · 2023Article
- Recent innovations in adaptive trial designs: A review of design opportunities in translational research.Journal of clinical and translational science · 2023Review
- Approximate Bayesian computation design for phase I clinical trials.Statistical methods in medical research · 2022Article
- Explicit underdose control based on toxicity: Four points to consider.Statistics in medicine · 2022Article
- Designing phase I oncology dose escalation using dose-exposure-toxicity models as a complementary approach to model-based dose-toxicity models.CPT: pharmacometrics & systems pharmacology · 2022Article
- Anti-cancer drug combinations approved by US FDA from 2011 to 2021: main design features of clinical trials and role of pharmacokinetics.Cancer chemotherapy and pharmacology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
Abstract
purposeWe provide a comprehensive review of adaptive phase I clinical trials in oncology that used a statistical model to guide dose escalation to identify the maximum-tolerated dose (MTD). We describe the clinical setting, practical implications, and safety of such applications, with the aim of understanding how these designs work in practice.
methodsWe identified 53 phase I trials published between January 2003 and September 2013 that used the continual reassessment method (CRM), CRM using escalation with overdose control, or time-to-event CRM for late-onset toxicities. Study characteristics, design parameters, dose-limiting toxicity (DLT) definition, DLT rate, patient-dose allocation, overdose, underdose, sample size, and trial duration were abstracted from each study. In addition, we examined all studies in terms of safety, and we outlined the reasons why escalations occur and under what circumstances.
resultsOn average, trials accrued 25 to 35 patients over a 2-year period and tested five dose levels. The average DLT rate was 18%, which is lower than in previous reports, whereas all levels above the MTD had an average DLT rate of 36%. On average, 39% of patients were treated at the MTD, and 74% were treated at either the MTD or an adjacent level (one level above or below).
conclusionThis review of completed phase I studies confirms the safety and generalizability of model-guided, adaptive dose-escalation designs, and it provides an approach for using, interpreting, and understanding such designs to guide dose escalation in phase I trials.
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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.