Evidence map›Paper›PMID 26681315›Full record

ArticleGenetics in medicine : official journal of the American College of Medical Genetics2016

Pharmacogenomic biomarkers as inclusion criteria in clinical trials of oncology-targeted drugs: a mapping of ClinicalTrials.gov.

Alexandre Vivot, Jacques Li, Jean-David Zeitoun, Samia Mourah, Perrine Crequit, Philippe Ravaud, Raphaël Porcher

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Article in Genetics in medicine : official journal of the American College of Medical Genetics, 2016. 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. Article
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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

7 authors.

Alexandre VivotAssistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Centre d'Épidémiologie Clinique, Paris, France.
Jacques LiAssistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Centre d'Épidémiologie Clinique, Paris, France.
Jean-David ZeitounAssistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Centre d'Épidémiologie Clinique, Paris, France.
Samia MourahDepartment of Pharmacology-Genetics, Assistance Publique des Hôpitaux de Paris (AP-HP), Saint-Louis Hospital, Paris, France.
Perrine CrequitAssistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Centre d'Épidémiologie Clinique, Paris, France.
Philippe RavaudAssistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Centre d'Épidémiologie Clinique, Paris, France.
Raphaël PorcherAssistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Centre d'Épidémiologie Clinique, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe aim of this study was to describe pharmacogenomics-based inclusion criteria (enrichment) and the main characteristics of clinical trials involving oncology-targeted therapies.

methodsClinical trials of oncology-targeted therapies approved after 2005 with pharmacogenomic testing required or recommended in their label were retrieved from a mapping of the ClinicalTrials.gov database.

resultsWe examined information for 12 drugs and 858 trials. Overall, 434 trials (51%) were enriched on the biomarker first mentioned in the label and 145 (17%) were enriched on another biomarker, whereas 270 trials (31%) included all patients. The median proportion of trials corresponding to both the drug's indication and drug's target was 35%. Of the 361 trials that tested drugs in another disease than the first one in the label, 219 (61%) were without enrichment and 87 (24%) were actually enriched but on another biomarker than the first one in the label.

conclusionSeveral drugs have been tested in trials enriched on many different biomarkers. Nonetheless, most targeted therapies have been developed only using biomarker-positive patients; therefore, exclusion of biomarker-negative patients from treatment relies on only preclinical data and on biological understanding of the disease and target.Genet Med 18 8, 796-805.

Indexed as

Pharmacogenomic VariantsAntineoplastic AgentsBiomarkers, TumorClinical Trials as TopicDrug LabelingHumansMolecular Targeted TherapyNeoplasmsUnited StatesUnited States Food and Drug AdministrationAntineoplastic AgentsBiomarkers, Tumor

Identifiers

PMID26681315

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.