Evidence map›Paper›PMID 42533595›Full record

ArticleCPT: pharmacometrics & systems pharmacology2026

Refinement of Operating Characteristics for Model-Based TGI Metrics Decision Support to Ungate a Pivotal Trial in Oncology.

Mathilde Marchand, Kenta Yoshida, Antonio Gonçalves, Rene Bruno, Chunze Li, Jin Y Jin, Pascal Chanu

Abstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Mathilde MarchandCertara Integrated Drug Development, Paris, France.ORCID 0000-0002-9130-9980
Kenta YoshidaClinical Pharmacology, Genentech, South San Francisco, California, USA.ORCID 0000-0003-4967-3831
Antonio GonçalvesCertara Integrated Drug Development, Paris, France.ORCID 0000-0002-8759-2429
Rene BrunoR&B Pharmacometrics, Marseille, France.ORCID 0000-0003-0200-039X
Chunze LiClinical Pharmacology, Genentech, South San Francisco, California, USA.ORCID 0000-0002-8906-6553
Jin Y JinClinical Pharmacology, Genentech, South San Francisco, California, USA.ORCID 0000-0002-3627-0323
Pascal ChanuClinical Pharmacology, Genentech-Roche, Lyon, France.ORCID 0000-0001-9011-5431

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The oncology market is evolving, with an increasing number of therapeutic options making the inference of treatment benefit from early development critical. The "Go" versus "No Go" decisions from such trials usually rely on probabilities of achieving meaningful improvements (effect sizes) in endpoints like objective response rate, tailored to products' profile, supporting faster transitions to confirmatory trials. Operating characteristics are sensitive to methodological details, important for establishing an early decision framework for ungating a pivotal clinical trial.

Indexed as

Antineoplastic AgentsClinical Trials as TopicDecision Support TechniquesNeoplasmsHumansMedical OncologyResearch DesignAntineoplastic Agentsdecision makingeffect sizeoperating characteristicstumor growth inhibition metrics

Identifiers

PMID42533595
PMCPMC13425608

What OpenQuestion holds

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Registered trials

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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.