Evidence map›Paper›PMID 37378271›Full record

ReviewJournal of applied statistics2023

Evaluation of phase I clinical trial designs for combinational agents along with guidance based on simulation studies.

Shu Wang, Elias Sayour, Ji-Hyun Lee

Abstract readReview
In one paragraph

Review in Journal of applied statistics, 2023. 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

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.

  1. Article
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

3 authors.

Shu WangDivision of Quantitative Sciences, UF Health, Gainesville, FL, USA.
Elias SayourDepartment of Neurosurgery, University of Florida, Gainesville, FL, USA.
Ji-Hyun LeeDivision of Quantitative Sciences, UF Health, Gainesville, FL, USA.ORCID https://orcid.org/0000-0001-6420-5150

Funding

Overcoming the blood-brain barrier with nanoparticle vaccines against gliomasR37CA251978 · NCI · UNIVERSITY OF FLORIDA · PI Elias Sayour · 2021 to 2026
$3.4M
NCI NIH HHS R37 CA251978
6 · The paper itself

Abstract

Combinational therapy that combines two or more therapeutic agents is very common in cancer treatment. Currently, many clinical trials aim to assess feasibility, safety and activity of combinational therapeutics to achieve synergistic response. Dose-finding for combinational agents is considerably more complex than single agent, because only partial order of dose combinations' toxicity is known. Prototypical phase I designs may not adequately capture this complexity thus limiting identification of the maximum tolerated dose (MTD) of combinational agents. In response, novel phase I clinical trial designs for combinational agents have been extensively proposed. However, with so many available designs, studies that compare their performances and explore the impact of design parameters, along with providing recommendations are limited. We are evaluating available phase I designs that identify a single MTD for combinational agents using simulation studies under various conditions. We are also exploring the influences of different design parameters and summarizing the risks/benefits of each design to provide general guidance in design selection.

Indexed as

combinational agentsdose-findingguidance for phase IPhase I clinical trial

Identifiers

PMID37378271
PMCPMC10291942

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.