Evidence map›Paper›PMID 32580715›Full record

ArticleBMC medical informatics and decision making2020

GUIP1: a R package for dose escalation strategies in phase I cancer clinical trials.

D Dinart, J Fraisse, D Tosi, A Mauguen, C Touraine, S Gourgou, M C Le Deley, C Bellera, C Mollevi

Open access · goldAbstract read
In one paragraph

Article in BMC medical informatics and decision making, 2020. 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
0.9field-weighted citation impact, top 24% of its field
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

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. A Road Map for Designing Phase I Clinical Trials of Radiotherapy-Novel Agent Combinations.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 2 countries.

D DinartInserm CIC1401, Module Epidémiologie Clinique, Institut Bergonié, Bordeaux, France.
J FraisseInstitut du Cancer Montpellier (ICM), Université de Montpellier, Montpellier, France.
D TosiInstitut du Cancer Montpellier (ICM), Université de Montpellier, Montpellier, France.
A MauguenMemorial Sloan Kettering Cancer Center, New York, USA.
C TouraineInstitut du Cancer Montpellier (ICM), Université de Montpellier, Montpellier, France.
S GourgouInstitut du Cancer Montpellier (ICM), Université de Montpellier, Montpellier, France.
M C Le DeleyCentre Oscar Lambret, Lille, France.
C BelleraInserm CIC1401, Module Epidémiologie Clinique, Institut Bergonié, Bordeaux, France.
C MolleviInstitut du Cancer Montpellier (ICM), Université de Montpellier, Montpellier, France. Caroline.Mollevi@icm.unicancer.fr.ORCID http://orcid.org/0000-0003-4827-3684
Institut de Recherche en Cancérologie de Montpellier · FRInserm · FRMemorial Sloan Kettering Cancer Center · USUniversité Paris-Sud · FR

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Elisa de Stanchina · 1985 to 2026
$347.4M
INCA SHSESP-007NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThe main objective of phase I cancer clinical trials is to identify the maximum tolerated dose, usually defined as the highest dose associated with an acceptable level of severe toxicity during the first cycle of treatment. Several dose-escalation designs based on mathematical modeling of the dose-toxicity relationship have been developed. The main ones are: the continual reassessment method (CRM), the escalation with overdose control (EWOC) method and, for late-onset and cumulative toxicities, the time-to-event continual reassessment method (TITE-CRM) and the time-to-event escalation with overdose control (TITE-EWOC) methods. The objective of this work was to perform a user-friendly R package that combines the latter model-guided adaptive designs.

resultsGUIP1 is an R Graphical User Interface for dose escalation strategies in Phase 1 cancer clinical trials. It implements the CRM (based on Bayesian or maximum likelihood estimation), EWOC and TITE-CRM methods using the dfcrm and bcrm R packages, while the TITE-EWOC method has been specifically developed. The program is built using the TCL/TK programming language, which can be compiled via R software libraries (tcltk, tkrplot, tcltk2). GUIP1 offers the possibility of simulating and/or conducting and managing phase I clinical trials in real-time using file management options with automatic backup of study and/or simulation results.

conclusionsGUIP1 is implemented using the software R, which is widely used by statisticians in oncology. This package simplifies the use of the main model-based dose escalation methods and is designed to be fairly simple for beginners in R. Furthermore, it offers multiple possibilities such as a full traceability of the study. By including multiple innovative adaptive methods in a free and user-friendly program, we hope that GUIP1 will promote and facilitate their use in designing future phase I cancer clinical trials.

Indexed as

NeoplasmsBayes TheoremComputer SimulationDose-Response Relationship, DrugHumansMaximum Tolerated DoseResearch DesignDose escalation designGraphical user interfacePhase 1 clinical trial

Identifiers

PMID32580715
PMCPMC7469913
OpenAlexW3037518813

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.