Evidence map›Paper›PMID 30808815›Full record

ReviewThe oncologist2019

Predictors of Success of Phase II Pediatric Oncology Clinical Trials.

Laura Franshaw, Maria Tsoli, Jennifer Byrne, Chelsea Mayoh, Siva Sivarajasingam, Murray Norris, Glenn M Marshall, David S Ziegler

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The oncologist, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. 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

8 authors.

Laura FranshawChildren's Cancer Institute, University of New South Wales, Randwick, Australia.
Maria TsoliChildren's Cancer Institute, University of New South Wales, Randwick, Australia.
Jennifer ByrneThe Children's Hospital at Westmead, Children's Cancer Research Unit, and University of Sydney, Discipline of Child and Adolescent Health, Sydney, Australia.
Chelsea MayohChildren's Cancer Institute, University of New South Wales, Randwick, Australia.
Siva SivarajasingamChildren's Cancer Institute, University of New South Wales, Randwick, Australia.
Murray NorrisChildren's Cancer Institute, University of New South Wales, Randwick, Australia.
Glenn M MarshallChildren's Cancer Institute, University of New South Wales, Randwick, Australia.
David S ZieglerChildren's Cancer Institute, University of New South Wales, Randwick, Australia d.ziegler@unsw.edu.au.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere are limited data to predict which novel childhood cancer therapies are likely to be successful. To help rectify this, we sought to identify the factors that impact the success of phase II clinical trials for pediatric malignancies. MATERIALS AND

methodsWe examined the impact of 24 preclinical and trial design variables for their influence on 132 phase II pediatric oncology clinical trials. Success was determined by an objective assessment of patient response, with data analyzed using Fisher's exact test, Pearson's chi-square test, and logistic regression models.

resultsTrials that evaluated patients with a single histological cancer type were more successful than those that assessed multiple different cancer types (68% vs. 47%, 27%, and 17% for 1, 2-3, 4-7, and 8+;

conclusionPhase II pediatric oncology clinical trials that examine a single cancer type and use combination therapies have the highest possibility of clinical success. Trials building upon a standard treatment regimen were also more successful. The conduct of preclinical experiments did not improve clinical success, emphasizing the need for a better understanding of the translational relevance of current preclinical testing paradigms. IMPLICATIONS FOR PRACTICE: To improve the clinical outcomes of phase II childhood cancer trials, this study identified factors impacting clinical success. These results have the potential to impact not only the design of future clinical trials but also the assessment of preclinical studies moving forward. This work found that trials on one histological cancer type and trials testing combination therapies had the highest possibility of success. Incorporation of novel therapies into standard treatment backbones led to higher success rates than testing novel therapies alone. This study found that most trials had no preclinical evidence to support initiation, and even when preclinical studies were available, they did not result in improved success.

Indexed as

ChildClinical Trials, Phase II as TopicDrug Evaluation, PreclinicalGuidelines as TopicHumansNeoplasmsPediatricsResearch DesignOncologyPediatricPhase IIPredictorsSuccess

Identifiers

PMID30808815
PMCPMC6693728

What OpenQuestion holds

Textmetadata
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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.