Evidence map›Paper›PMID 35064957›Full record

ArticleCPT: pharmacometrics & systems pharmacology2022

A workflow for the joint modeling of longitudinal and event data in the development of therapeutics: Tools, statistical methods, and diagnostics.

Kirill Zhudenkov, Sergey Gavrilov, Alina Sofronova, Oleg Stepanov, Nataliya Kudryashova, Gabriel Helmlinger, Kirill Peskov

Open access · goldAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 7% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

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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 at 2 institutions in 2 countries.

Kirill ZhudenkovM&S Decisions LLC, Moscow, Russia.
Sergey GavrilovM&S Decisions LLC, Moscow, Russia.
Alina SofronovaM&S Decisions LLC, Moscow, Russia.
Oleg StepanovM&S Decisions LLC, Moscow, Russia.
Nataliya KudryashovaM&S Decisions LLC, Moscow, Russia.
Gabriel HelmlingerClinical Pharmacology & Toxicology, Obsidian Therapeutics, Cambridge, Massachusetts, USA.
Kirill PeskovM&S Decisions LLC, Moscow, Russia.
Health Decisions (United States) · USIo Therapeutics (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Clinical trials investigate treatment endpoints that usually include measurements of pharmacodynamic and efficacy biomarkers in early-phase studies and patient-reported outcomes as well as event risks or rates in late-phase studies. In recent years, a systematic trend in clinical trial data analytics and modeling has been observed, where retrospective data are integrated into a quantitative framework to prospectively support analyses of interim data and design of ongoing and future studies of novel therapeutics. Joint modeling is an advanced statistical methodology that allows for the investigation of clinical trial outcomes by quantifying the association between baseline and/or longitudinal biomarkers and event risk. Using an exemplar data set from non-small cell lung cancer studies, we propose and test a workflow for joint modeling. It allows a modeling scientist to comprehensively explore the data, build survival models, investigate goodness-of-fit, and subsequently perform outcome predictions using interim biomarker data from an ongoing study. The workflow illustrates a full process, from data exploration to predictive simulations, for selected multivariate linear and nonlinear mixed-effects models and software tools in an integrative and exhaustive manner.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsBiomarkersHumansLongitudinal StudiesModels, StatisticalRetrospective StudiesWorkflowBiomarkers

Identifiers

PMID35064957
PMCPMC9007602
OpenAlexW4206994906

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.