ArticleContemporary clinical trials2016
Integrating the escalation and dose expansion studies into a unified Phase I clinical trial.
Article in Contemporary clinical trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed.
- Applications of the partial-order continual reassessment method in the early development of treatment combinations.Clinical trials (London, England) · 2024Article
- Controlled amplification in oncology dose-finding trials.Contemporary clinical trials · 2023Article
- Stopping rules for phase I clinical trials with dose expansion cohorts.Statistical methods in medical research · 2022Article
- Phase I clinical trials in adoptive T-cell therapies.Journal of the Royal Statistical Society. Series C, Applied statistics · 2021Article
- Calcium electroporation for recurrent head and neck cancer: A clinical phase I study.Laryngoscope investigative otolaryngology · 2019Article
- Overcoming obstacles in the design of cancer anorexia/weight loss trials.Critical reviews in oncology/hematology · 2017Review
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
We focus on Phase I dose finding studies as they are currently undertaken. The design and analysis of these trials have changed over the last years and, in particular, it is now rare for a Phase I study to not include one or more dose-expansion cohorts (DEC). It is common to see DEC involving several hundred patients, building on an initial dose escalation study that may have no >20 to 30 patients. There has been recent focus by researchers on the design of DEC and the analysis of DEC data. It is reasonable to explicitly account for the uncertainty in the estimation of the MTD, the dose upon which the whole of the DEC is currently based. In this paper, we focus on the dose escalation phase prior to the DEC, with the purpose of adapting it to the needs of DEC. Specifically, before beginning the DEC phase, we need to identify those dose levels that will be taken into the DEC. We define a useful concept for this purpose, the co-MTD, and the results support that the estimated MTD and co-MTD contain the true MTD with high probability. We also provide stopping rules for when the data support that the dose escalation can end and the dose expansion can begin. Simulated trials support the use of the proposed approach and provide additional information on how this approach compares with current practice.
Indexed as
Identifiers
What OpenQuestion holds
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.