Evidence map›Paper›PMID 36380294›Full record

ArticleBMC medical informatics and decision making2022

In silico clinical trials for relapsing-remitting multiple sclerosis with MS TreatSim.

Fianne L P Sips, Francesco Pappalardo, Giulia Russo, Roberta Bursi

Open access · goldAbstract read
In one paragraph

Article in BMC medical informatics and decision making, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.1field-weighted citation impact, top 12% 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

7 citing papers in PubMed, 16 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

4 authors at 2 institutions in 2 countries.

Fianne L P SipsInSilicoTrials Technologies, 's-Hertogenbosch, Netherlands.
Francesco PappalardoDepartment of Drug and Health Sciences, University of Catania, Catania, Italy.
Giulia RussoDepartment of Drug and Health Sciences, University of Catania, Catania, Italy.
Roberta BursiInSilicoTrials Technologies, 's-Hertogenbosch, Netherlands. roberta.bursi@insilicotrials.com.ORCID http://orcid.org/0000-0001-9118-3786
University of Catania · ITENPICOM (Netherlands) · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe last few decades have seen the approval of many new treatment options for Relapsing-Remitting Multiple Sclerosis (RRMS), as well as advances in diagnostic methodology and criteria. These developments have greatly improved the available treatment options for today's Relapsing-Remitting Multiple Sclerosis patients. This increased availability of disease modifying treatments, however, has implications for clinical trial design in this therapeutic area. The availability of better diagnostics and more treatment options have not only contributed to progressively decreasing relapse rates in clinical trial populations but have also resulted in the evolution of control arms, as it is often no longer sufficient to show improvement from placebo. As a result, not only have clinical trials become longer and more expensive but comparing the results to those of "historical" trials has also become more difficult.

methodsIn order to aid design of clinical trials in RRMS, we have developed a simulator called MS TreatSim which can simulate the response of customizable, heterogeneous groups of patients to four common Relapsing-Remitting Multiple Sclerosis treatment options. MS TreatSim combines a mechanistic, agent-based model of the immune-based etiology of RRMS with a simulation framework for the generation and virtual trial simulation of populations of digital patients.

resultsIn this study, the product was first applied to generate diverse populations of digital patients. Then we applied it to reproduce a phase III trial of natalizumab as published 15 years ago as a use case. Within the limitations of synthetic data availability, the results showed the potential of applying MS TreatSim to recreate the relapse rates of this historical trial of natalizumab.

conclusionsMS TreatSim's synergistic combination of a mechanistic model with a clinical trial simulation framework is a tool that may advance model-based clinical trial design.

Indexed as

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingHumansNatalizumabRecurrenceNatalizumabComputational modeling and simulationDigital patientIn silico trialsRelapsing-Remitting Multiple SclerosisStudy design

Identifiers

PMID36380294
PMCPMC9665027
OpenAlexW4309223542

What OpenQuestion holds

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LicenceCC BY
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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.