Evidence map›Paper›PMID 39985154›Full record

ArticleCPT: pharmacometrics & systems pharmacology2025

Tutorial on Conditional Simulations With a Tumor Size-Overall Survival Model to Support Oncology Drug Development.

Sebastiaan C Goulooze, Morris Muliaditan, Richard C Franzese, Alejandro Mantero, Sandra A G Visser, Murad Melhem, Teun M Post, Chetan Rathi, Herbert Struemper

Abstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

9 authors.

Sebastiaan C GouloozeLAP&P Consultants, Leiden, the Netherlands.ORCID 0000-0003-3369-6107
Morris MuliaditanLAP&P Consultants, Leiden, the Netherlands.ORCID 0009-0000-9003-4666
Richard C FranzeseClinical Pharmacology Modeling & Simulation, GSK, Upper Providence, Pennsylvania, USA.
Alejandro ManteroOncology Biostatistics, GSK, Upper Providence, Pennsylvania, USA.ORCID 0000-0001-8462-9487
Sandra A G VisserClinical Pharmacology Modeling & Simulation, GSK, Upper Providence, Pennsylvania, USA.ORCID 0009-0008-2186-7195
Murad MelhemClinical Pharmacology Modeling & Simulation, GSK, Waltham, Massachusetts, USA.
Teun M PostLAP&P Consultants, Leiden, the Netherlands.ORCID 0000-0001-9183-2678
Chetan RathiClinical Pharmacology Modeling & Simulation, GSK, Waltham, Massachusetts, USA.ORCID 0000-0003-1015-5199
Herbert StruemperClinical Pharmacology Modeling & Simulation, GSK, Durham, North Carolina, USA.ORCID 0000-0003-3011-1572

Funding

GSK
6 · The paper itself

Abstract

The gold standard for regulatory approval in oncology is overall survival (OS). Because OS data are initially limited, early drug development decisions are often based on early efficacy endpoints, such as objective response rate and progression-free survival. Tumor size (TS)-OS models provide a framework to support decision-making on potential late-stage success based on early readouts, through leveraging TS data with limited follow-up and treatment-agnostic TS-OS link functions, to predict longer-term OS. Conditional simulations (also known as Bayesian forecasting) with TS-OS models can be used to simulate long-term OS outcomes for an ongoing study, conditional on the available TS and OS data at interim data cuts of the same study. This tutorial provides a comprehensive overview of the steps involved in using such conditional simulations to support better informed drug development decisions in oncology. The tutorial covers the selection of the TS-OS framework model; applying the TS-OS model to the interim data; performing conditional simulations; generating relevant output; as well as correct interpretation and communication of the output for decision making.

Indexed as

Antineoplastic AgentsDrug DevelopmentNeoplasmsTumor BurdenBayes TheoremComputer SimulationHumansAntineoplastic Agentsmethodologymodel‐based drug developmentoncologypopulation pharmacodynamicssimulationsurrogate endpointsurvival analysistumors

Identifiers

PMID39985154
PMCPMC12001264

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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.