Evidence map›Paper›PMID 36203850›Full record

ArticleContemporary clinical trials communications2022

A software tool for both the maximum tolerated dose and the optimal biological dose finding trials in early phase designs.

Chen Li, Hongying Sun, Cheng Cheng, Li Tang, Haitao Pan

Abstract read
In one paragraph

Article in Contemporary clinical trials communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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

What it found

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2 · The registry

The trial behind it

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3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

5 authors.

Chen LiDepartment of Health Statistics, School of Preventive Medicine, Fourth Military Medical University, China.
Hongying SunRNA Computational Scientist, Takeda Pharmaceuticals, United States of America.
Cheng ChengDepartment of Biostatistics, St. Jude Children's Research Hospital, United States of America.
Li TangDepartment of Biostatistics, St. Jude Children's Research Hospital, United States of America.
Haitao PanDepartment of Biostatistics, St. Jude Children's Research Hospital, United States of America.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Phase I and/or I/II oncology trials are conducted to find the maximum tolerated dose (MTD) and/or optimal biological dose (OBD) of a new drug or treatment. In these trials, for cytotoxic agents, the primary aim of the single-agent or drug-combination is to find the MTD with a certain target toxicity rate, while for the cytostatic agents, a more appropriate target is the OBD, which is often defined by considering of toxicity and efficacy simultaneously. Accessible software packages to achieve both these aims are needed. Results: The objective of this study is to develop a software package that can provide tools for both MTD- and OBD-finding trials, which implements the Keyboard design for single-agent MTD-finding trials as reported by Yan et al. (2017), the Keyboard design for drug-combination MTD-finding trials by Pan et al. (2020), and a phase I/II OBD-finding method by Li et al. (2017) in a single R package, called Keyboard. For each of the designs, the Keyboard package provides corresponding functions such as get.boundary ( Conclusion: The Keyboard R package developed herein provides convenient tools for designing, conducting and analyzing single-agent, drug-combination, phase I/II OBD-finding trials.

Indexed as

Bayesian adaptive designDose-findingMaximum tolerated doseOptimal biological dosePhase I/II trials

Identifiers

PMID36203850
PMCPMC9529556

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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.