Evidence map›Paper›PMID 31656956›Full record

ReviewFuture drug discovery2019

Practical considerations for the implementation of adaptive designs for oncology Phase I dose-finding trials.

Lai Wei, Xueliang Pan, Soledad Fernandez

Abstract readReview
In one paragraph

Review in Future drug discovery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. 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

3 authors.

Lai WeiCenter for Biostatistics, Department of Biomedical Informatics, College of Medicine, The Ohio State University, 1800 Cannon Dr. Columbus, OH 43210, USA.
Xueliang PanCenter for Biostatistics, Department of Biomedical Informatics, College of Medicine, The Ohio State University, 1800 Cannon Dr. Columbus, OH 43210, USA.
Soledad FernandezCenter for Biostatistics, Department of Biomedical Informatics, College of Medicine, The Ohio State University, 1800 Cannon Dr. Columbus, OH 43210, USA.

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Tasleem J Padamsee · 1985 to 2026
$132.3M
The OSU Center for Clinical and Translational Science: Advancing Today's Discoveries to Improve HealthUL1TR002733 · NCATS · OHIO STATE UNIVERSITY · PI RINGEL, MATTHEW D · 2018 to 2022
$28.9M
UM1 Supplement for Early Therapeutic Trials with Phase 2 IntentUM1CA186712 · NCI · OHIO STATE UNIVERSITY · PI SUSANNE M ARNOLD, WILLIAM E. CARSON · 2014 to 2026
$19.3M
PHASE I TRIALS OF ANTICANCER AGENTSU01CA076576 · NCI · OHIO STATE UNIVERSITY · PI GREVER, MICHAEL R · 1998 to 2013
$9.1M
Urine antimicrobial proteins in older adults: aging, infection, & innate immunityR01AG050801 · NIA · OHIO STATE UNIVERSITY · PI CATERINO, JEFFREY M · 2016 to 2020
$2.8M
A live attenuated vaccine for leishmaniasisR21AI130485 · NIAID · OHIO STATE UNIVERSITY · PI SATOSKAR, ABHAY R, ZHIOUA, ELYES · 2018 to 2019
$376k
NCATS NIH HHS UL1 TR002733NCI NIH HHS P30 CA016058NCI NIH HHS U01 CA076576NCI NIH HHS UM1 CA186712NIAID NIH HHS R21 AI130485NIA NIH HHS R01 AG050801
6 · The paper itself

Abstract

The traditional 3 + 3 design continues to be commonly used for Phase I dose-finding oncology trials, despite increasing criticisms and development of innovative methods. Unfortunately, it is a challenge to convince principal investigators to use novel designs. The goal of this paper is to persuade researchers to break away from 3 + 3 design and provide potential solutions to better designs and implementation strategy. We reviewed the statistical methods for adaptive Phase I designs. The barriers among all the major components of the implementation team have been emphasized and potential solutions have been discussed. Institutional support to the principal investigators and statistician, as well as to other team members is essential to design and implement adaptive trials in academic medical institutions.

Indexed as

3 + 3adaptive designsalgorithm-basedmodel-assistedmodel-basedoncology Phase I dose-finding design

Identifiers

PMID31656956
PMCPMC6811732

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.