Evidence map›Paper›PMID 41095986›Full record

ArticleJournal of clinical medicine2025

Decentralized Clinical Trials in Pediatrics: Is Italy Ready?

Gilda Paternuosto, Anna Flamigni, Monica Zanier, Barbara Bonifacio, Giulia Schillani, Mario Cirino, Sasa Krcalic, Silvia Tommasi, Fatima Tizi, Anna Arbo and 2 more

Abstract readComment
In one paragraph

Article in Journal of clinical medicine, 2025. 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

12 authors.

Gilda PaternuostoInstitute for Maternal and Child Health, IRCCS Burlo Garofolo, 34137 Trieste, Italy.ORCID 0009-0003-1506-6184
Anna FlamigniInstitute for Maternal and Child Health, IRCCS Burlo Garofolo, 34137 Trieste, Italy.ORCID 0009-0007-5766-2717
Monica ZanierInstitute for Maternal and Child Health, IRCCS Burlo Garofolo, 34137 Trieste, Italy.
Barbara BonifacioInstitute for Maternal and Child Health, IRCCS Burlo Garofolo, 34137 Trieste, Italy.
Giulia SchillaniInstitute for Maternal and Child Health, IRCCS Burlo Garofolo, 34137 Trieste, Italy.
Mario CirinoInstitute for Maternal and Child Health, IRCCS Burlo Garofolo, 34137 Trieste, Italy.ORCID 0000-0003-1803-1780
Sasa KrcalicInstitute for Maternal and Child Health, IRCCS Burlo Garofolo, 34137 Trieste, Italy.
Silvia TommasiInstitute for Maternal and Child Health, IRCCS Burlo Garofolo, 34137 Trieste, Italy.
Fatima TiziInstitute for Maternal and Child Health, IRCCS Burlo Garofolo, 34137 Trieste, Italy.ORCID 0009-0009-8001-3314
Anna ArboInstitute for Maternal and Child Health, IRCCS Burlo Garofolo, 34137 Trieste, Italy.
Davide ZanonInstitute for Maternal and Child Health, IRCCS Burlo Garofolo, 34137 Trieste, Italy.ORCID 0000-0003-1350-0509
Alessandra MaestroInstitute for Maternal and Child Health, IRCCS Burlo Garofolo, 34137 Trieste, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Driven by technological advances and regulatory developments, the clinical trials industry is undergoing a period of transformation. Decentralized clinical trials (DCTs) promise to streamline processes, increase participant engagement and improve data quality. The pediatric clinical trial landscape is challenging, as participation in a clinical trial affects the whole family. DCTs allow for increased patient engagement, thereby improving trial quality and consequently drug safety. The Italian Medicines Agency (AIFA), in its quest for regulatory simplification and alignment with the European framework, has established comprehensive guidelines to facilitate these decentralized trials. The present work aims to delve into the regulations to understand the feasibility of conducting decentralized pediatric trials in Italy.

Indexed as

clinical trial regulationsdecentralized clinical trialsdigital health technologiesengagementinformed consentpediatric clinical trial

Identifiers

PMID41095986
PMCPMC12525281

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.