Evidence map›Paper›PMID 26833922›Full record

ArticleStatistics in medicine2016

The rapid enrollment design for Phase I clinical trials.

Anastasia Ivanova, Yunfei Wang, Matthew C Foster

Abstract read
In one paragraph

Article in Statistics in medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Trial
  2. Review
  3. 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. Article
  5. Article
  6. Article
  7. A Bayesian model-free approach to combination therapy phase I trials using censored time-to-toxicity data.Journal of the Royal Statistical Society. Series C, Applied statistics · 2019
    Article
  8. Article
  9. 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.

Anastasia IvanovaDepartment of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599-7420, U.S.A.
Yunfei WangDepartments of Pediatrics and Biostatistics, George Washington University and Children's National Medical Center, Washington DC, 20010, U.S.A.
Matthew C FosterUniversity of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC, 27599, U.S.A.

Funding

Virology Research Program (Program 4)P30CA016086 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI David Darr · 1985 to 2026
$201.5M
Statistical Methods for Cancer Clinical TrialsP01CA142538 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI TSIATIS, ANASTASIOS A · 2010 to 2019
$21.3M
Current Design Issues in Oncology TrialsR01CA120082 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI IVANOVA, ANASTASIA · 2006 to 2008
$403k
NCI NIH HHS P01 CA142538NCI NIH HHS P30 CA016086NCI NIH HHS R01 CA120082
6 · The paper itself

Abstract

We propose a dose-finding design for Phase I oncology trials where each new patient is assigned to the dose most likely to be the target dose given observed data. The main model assumption is that the dose-toxicity curve is non-decreasing. This method is beneficial when it is desirable to assign a patient to a dose as soon as the patient is enrolled into a study. To prevent assignments to doses with limited toxicity information in fast accruing trials we propose a conservative rule that assigns temporary fractional toxicities to patients still in follow-up. We also recommend always using a safety rule in any fast accruing dose-finding trial. Copyright © 2016 John Wiley & Sons, Ltd.

Indexed as

Clinical Trials, Phase I as TopicResearch DesignDose-Response Relationship, DrugHumansMaximum Tolerated DoseMedical OncologyPatient SelectionCRMmTPIPhase I trialREDTITE-CRM

Identifiers

PMID26833922
PMCPMC4892992

What OpenQuestion holds

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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.