Evidence map›Paper›PMID 27780857›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2017

Enrolling Adolescents in Disease/Target-Appropriate Adult Oncology Clinical Trials of Investigational Agents.

Meredith K Chuk, Yeruk Mulugeta, Michelle Roth-Cline, Nitin Mehrotra, Gregory H Reaman

Open access · bronzeAbstract readLetter
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
20.9field-weighted citation impact, top 1% 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

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
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  16. Timing of first-in-child trials of FDA-approved oncology drugs.European journal of cancer (Oxford, England : 1990) · 2019
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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

5 authors at 1 institution in 1 country.

Meredith K ChukOffice of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland. Meredith.Chuk@fda.hhs.gov.
Yeruk MulugetaOffice of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
Michelle Roth-ClineOffice of Pediatric Therapeutics, U.S. Food and Drug Administration, Silver Spring, Maryland.
Nitin MehrotraOffice of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
Gregory H ReamanOffice of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
United States Food and Drug Administration · US

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

The enrollment of adolescents with cancer in clinical trials is much lower than that of younger pediatric patients. For adolescents with "adult-type" cancers, lack of access to relevant trials is cited as one of the reasons for this discrepancy. Adolescents are generally not eligible for enrollment in adult oncology trials, and initial pediatric trials for many drugs are conducted years later, often after the drug is approved. As a result, accrual of adolescents to these trials may be slow due to off-label use, prospectively collected safety and efficacy data are lacking at the time of initial approval, and, most importantly, these adolescents have delayed access to effective therapies. To facilitate earlier access to investigational and approved drugs for adolescent patients with cancer, and because drug exposure is most often similar in adolescents and adults, we recommend the inclusion of adolescents (ages 12-17) in disease- and target-appropriate adult oncology trials. This approach requires careful monitoring for any differential safety signals, appropriate pharmacokinetic evaluations, and ensuring that ethical requirements are met. Inclusion of adolescents in adult oncology trials will require the cooperation of investigators, cooperative groups, industry, institutional review boards, and regulatory agencies to overcome real and perceived barriers. Clin Cancer Res; 23(1); 9-12. ©2016 AACR.

Indexed as

Antineoplastic AgentsClinical Trials as TopicDrugs, InvestigationalPatient SelectionAdolescentAdultAge FactorsHumansAntineoplastic AgentsDrugs, Investigational

Identifiers

PMID27780857
PMCPMC5217169
OpenAlexW2537263217

What OpenQuestion holds

Textmetadata
LicenceTDM
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.