ReviewContemporary clinical trials2016
Innovations for phase I dose-finding designs in pediatric oncology clinical trials.
Review 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 17 papers, 1 of them a synthesis that pooled it.
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
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Risk and surrogate benefit for pediatric Phase I trials in oncology: A systematic review with meta-analysis.PLoS medicine · 2018Pooled it
- Safety and efficacy of low-dose PI3K inhibitor taselisib in adult patients with CLOVES and Klippel-Trenaunay syndrome (KTS): the TOTEM trial, a phase 1/2 multicenter, open-label, single-arm study.Genetics in medicine : official journal of the American College of Medical Genetics · 2021Trial
- Commencement of Hypofractionated Adjuvant Radiation Therapy in Intermediate-Risk Oral Cavity Cancer: A Phase 1 Study Protocol (CHARIOT-1).Advances in radiation oncology · 2026Article
- Pediatric Cancer Drug Development: Leveraging Insights in Cancer Biology and the Evolving Regulatory Landscape to Address Challenges and Guide Further Progress.Cold Spring Harbor perspectives in medicine · 2024Review
- Review
- Pediatric oncology drug development and dosage optimization.Frontiers in oncology · 2023Review
- Oncolytic viruses in melanoma.Frontiers in bioscience (Landmark edition) · 2022Review
- Characteristics of Early Phase Clinical Trials for Rare Cancers: Insights From Interviews With Stakeholders.Frontiers in pharmacology · 2022Article
- Navigating the Regulatory Landscape to Develop Pediatric Oncology Drugs: Expert Opinion Recommendations.Paediatric drugs · 2021Review
- Comparison of Clinical Characteristics Between Clinical Trial Participants and Nonparticipants Using Electronic Health Record Data.JAMA network open · 2021Article
- Opportunities and Challenges in Drug Development for Pediatric Cancers.Cancer discovery · 2021Review
- Landscape of phase 1 clinical trials for minors with cancer in the United States.Pediatric blood & cancer · 2020Article
- Practical considerations for the implementation of adaptive designs for oncology Phase I dose-finding trials.Future drug discovery · 2019Review
- Time-to-Event Bayesian Optimal Interval Design to Accelerate Phase I Trials.Clinical cancer research : an official journal of the American Association for Cancer Research · 2018Article
- Unified approach for extrapolation and bridging of adult information in early-phase dose-finding paediatric studies.Statistical methods in medical research · 2018Article
- Early phase clinical trials of anticancer agents in children and adolescents - an ITCC perspective.Nature reviews. Clinical oncology · 2017Review
- Design and conduct of early phase drug studies in children: challenges and opportunities.British journal of clinical pharmacology · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
Phase I oncology clinical trials are designed to identify the optimal dose that will be recommended for phase II trials. In pediatric oncology, the conduct of those trials raises specific challenges, as the disease is rare with limited therapeutic options. In addition, the tolerance profile is known from adult trials. This paper provides a review of the major recent developments in the design of these trials, inspired by the need to cope with the specific challenges of dose finding in cancer pediatric oncology. We reviewed simulation studies comparing designs dedicated to address these challenges. We also reviewed the design used in published dose-finding trials in pediatric oncology over the period 2009-2014. Three main fields of innovation were identified. First, designs that were developed in order to relax the rules for more flexible inclusions. Second, methods to incorporate data emerging from adult studies. Third, designs accounting for toxicity evaluation at repeated cycles in pediatric oncology. In addition to this overview, we propose some further directions for designing pediatric dose-finding trials.
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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.