ArticleContemporary clinical trials2010
A simulation-based comparison of the traditional method, Rolling-6 design and a frequentist version of the continual reassessment method with special attention to trial duration in pediatric Phase I oncology trials.
Article in Contemporary clinical trials, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
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Who cites it
25 citing papers in PubMed.
- Nivolumab in children and young adults with relapsed or refractory solid tumours or lymphoma (ADVL1412): a multicentre, open-label, single-arm, phase 1-2 trial.The Lancet. Oncology · 2020Trial
- Randomized phase II trial of zolbetuximab as second-line treatment in patients with claudin 18.2-positive advanced gastric/GEJ cancer with previous zolbetuximab exposure: ZELDA.ESMO gastrointestinal oncology · 2026Article
- HS-10352 in hormone receptor-positive, HER2-negative advanced breast cancer: A phase 1 dose-escalation trial.Cancer medicine · 2023Article
- Comparison of design methods for a safety run-in phase of a phase II clinical trial.Clinical trials (London, England) · 2023Article
- Phase I CAR-T Clinical Trials Review.Anticancer research · 2022Review
- Phase I/Ib study of crenolanib with ramucirumab and paclitaxel as second-line therapy for advanced esophagogastric adenocarcinoma.Cancer chemotherapy and pharmacology · 2022Article
- Opportunities and Challenges in Drug Development for Pediatric Cancers.Cancer discovery · 2021Review
- Bayesian optimization for estimating the maximum tolerated dose in Phase I clinical trials.Contemporary clinical trials communications · 2021Article
- Phase 1 study of pomalidomide in children with recurrent, refractory, and progressive central nervous system tumors: A Pediatric Brain Tumor Consortium trial.Pediatric blood & cancer · 2021Article
- Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs.BMC medicine · 2020Article
- Landscape of phase 1 clinical trials for minors with cancer in the United States.Pediatric blood & cancer · 2020Article
- How to design a dose-finding study using the continual reassessment method.BMC medical research methodology · 2019Article
- Early phase clinical trials of anticancer agents in children and adolescents - an ITCC perspective.Nature reviews. Clinical oncology · 2017Review
- Toxicity-dependent feasibility bounds for the escalation with overdose control approach in phase I cancer trials.Statistics in medicine · 2017Article
- Phase I cancer clinical trials.Neuro-oncology practice · 2017Review
- Innovations for phase I dose-finding designs in pediatric oncology clinical trials.Contemporary clinical trials · 2016Review
- The changing landscape of phase I trials in oncology.Nature reviews. Clinical oncology · 2016Review
- AplusB: A Web Application for Investigating A + B Designs for Phase I Cancer Clinical Trials.PloS one · 2016Article
- Phase I study of 5-fluorouracil in children and young adults with recurrent ependymoma.Neuro-oncology · 2015Article
- A phase I trial and PK study of cediranib (AZD2171), an orally bioavailable pan-VEGFR inhibitor, in children with recurrent or refractory primary CNS tumors.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2015Article
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Abstract
The traditional method (TM), also known as the 3+3 up-and-down design, and the continual reassessment method (CRM) are commonly used in Phase I oncology trials to identify the maximum tolerated dose (MTD). The rolling-6 is a relative newcomer which was developed to shorten trial duration by minimizing the period of time during which the trial is closed to accrual for toxicity assessment. In this manuscript we have compared the performance of these three approaches via simulations not only with respect to the usual parameters such as overall toxicity, sample size and percentage of patients treated at doses above the MTD but also in terms of trial duration and the dose chosen as the MTD. Our results indicate that the toxicity rates are comparable across the three designs, but the TM and the rolling-6 tend to treat a higher percentage of patients at doses below the MTD. With respect to trial duration, rolling-6 leads to shorter trials compared to the TM but not compared to the CRM. Additionally, the doses identified as the MTD by the TM and the rolling-6 differ in a large percentage of trials. Our results also indicate that the body surface area-based dosing used in pediatric trials can make a difference in dose escalation/de-escalation patterns in the CRM compared to the cases where such variations are not taken into account in the calculations, even leading to different MTDs in some cases.
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