Evidence map›Paper›PMID 25974405›Full record

ArticleStatistics in medicine2015

A comparative study of adaptive dose-finding designs for phase I oncology trials of combination therapies.

Akihiro Hirakawa, Nolan A Wages, Hiroyuki Sato, Shigeyuki Matsui

Abstract readComparative Study
In one paragraph

Article in Statistics in medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed.

  1. Article
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  5. Review
  6. Article
  7. Article
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  10. Article
  11. Article
  12. Using an Interaction Parameter in Model-Based Phase I Trials for Combination Treatments? A Simulation Study.International journal of environmental research and public health · 2021
    Article
  13. A surface-free design for phase I dual-agent combination trials.Statistical methods in medical research · 2020
    Article
  14. Article
  15. Article
  16. The Impact of Early-Phase Trial Design in the Drug Development Process.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019
    Article
  17. Article
  18. Article
  19. Designs for phase I trials in ordered groups.Statistics in medicine · 2017
    Article
  20. Practical designs for Phase I combination studies in oncology.Journal of biopharmaceutical statistics · 2016
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

Akihiro HirakawaCenter for Advanced Medicine and Clinical Research, Nagoya University Graduate School of Medicine, Nagoya, 466-8550, Japan.
Nolan A WagesDepartment of Public Health Sciences, University of Virginia, Charlottesville, 22904, Virginia, U.S.A.
Hiroyuki SatoBiostatistics Group, Office of New Drug V, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan.
Shigeyuki MatsuiDepartment of Biostatistics, Nagoya University Graduate School of Medicine, Nagoya, 466-8550, Japan.

Funding

Phase I Designs for Combined Immunotherapies in CancerK25CA181638 · NCI · UNIVERSITY OF VIRGINIA · PI WAGES, NOLAN · 2014 to 2018
$780k
NCI NIH HHS 1K25CA181638NCI NIH HHS K25 CA181638
6 · The paper itself

Abstract

Little is known about the relative performance of competing model-based dose-finding methods for combination phase I trials. In this study, we focused on five model-based dose-finding methods that have been recently developed. We compared the recommendation rates for true maximum-tolerated dose combinations (MTDCs) and over-dose combinations among these methods under 16 scenarios for 3 × 3, 4 × 4, 2 × 4, and 3 × 5 dose combination matrices. We found that performance of the model-based dose-finding methods varied depending on (1) whether the dose combination matrix is square or not; (2) whether the true MTDCs exist within the same group along the diagonals of the dose combination matrix; and (3) the number of true MTDCs. We discuss the details of the operating characteristics and the advantages and disadvantages of the five methods compared.

Indexed as

Maximum Tolerated DoseAlgorithmsAntineoplastic Combined Chemotherapy ProtocolsBayes TheoremClinical Trials, Phase I as TopicComputer SimulationHumansLikelihood FunctionsLogistic ModelsNeoplasmscombination of two agentscomparative studydose-finding methodoncologyphase I trial

Identifiers

PMID25974405
PMCPMC4806394

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Registered 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.