Evidence map›Paper›PMID 40540194›Full record

ArticleTherapeutic innovation & regulatory science2025

Opportunities in Development of Patient-Centric and Decentralized Clinical Trials: Insights from Patients and Healthcare Professionals in Respiratory and Rare Diseases.

Marisa Minetti, Eva Topole, Ilaria Rondinone, Marta Lombardini, Paola Kruger, Mario Picozza, Simona Barbaglia, Andrea Terenzi, Ian Culverhouse, Lisa Forde and 2 more

Abstract read
In one paragraph

Article in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. 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

12 authors.

Marisa MinettiChiesi Farmaceutici, S.P.A., Parma, Italy. m.minetti@chiesi.com.ORCID http://orcid.org/0009-0007-6910-4325
Eva TopoleChiesi Farmaceutici, S.P.A., Parma, Italy.
Ilaria RondinoneChiesi Farmaceutici, S.P.A., Parma, Italy.
Marta LombardiniChiesi Farmaceutici, S.P.A., Parma, Italy.
Paola KrugerEUPATI, Rome, Italy.
Mario PicozzaFederAsma e Allergie ODV-Federazione Italiana Pazienti, Prato, Italy.
Simona BarbagliaAssociazione Nazionale Pazienti Respiriamo Insieme, Padua, Italy.
Andrea TerenziDoxa Pharma S.R.L., Milan, Italy.
Ian CulverhouseRebus Medical Ltd, Bristol, UK.
Lisa FordeRebus Medical Ltd, Bristol, UK.
Isabella MontagnaChiesi Farmaceutici, S.P.A., Parma, Italy.
Ylenia PaleariChiesi Farmaceutici, S.P.A., Parma, Italy. ylenia.paleari@icloud.com.ORCID http://orcid.org/0000-0002-8418-1501

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDecentralized clinical trials (DCTs) are increasingly being used to enable greater participation of patients in clinical research and improve the patient experience. In 2021, the Chiesi research and development team established the Digital innovAtion for patieNt Centric hEalth (DANCE) initiative with the aim to enhance the clinical trial journey for participants by merging patient perspectives with modern technology. As part of this project, the concept of DCTs was explored with patients affected by respiratory or rare diseases and with healthcare professionals (HCPs) treating these patients in the USA and Europe.

methodsThe concept of the clinical trial journey and DCTs were initially explored through semi-structured interviews with 37 patients and HCPs. A follow-on web survey of 390 patients and HCP participants was then performed to gather opinions on the different components of DCTs and to identify elements to be incorporated in future DCTs. A final web survey with 135 patients and caregivers expanded on the DCT concept focusing on direct-to-patient delivery of investigational medications.

resultsOverall, both patients and HCPs liked and were open to the concept of DCTs. They believed this approach in clinical trials would avoid patients having to travel long distances for screening or study visits, and increase participation of diverse populations in trials. The main concerns for both patients and HCP participants were the reduction of face-to-face interactions and whether the technology would be easy to use.

conclusionsThis work highlights the benefits of DCTs and identifies potential challenges to be addressed to make DCTs more appealing to all participants. Responses also demonstrate the significance of integrating face-to-face contact with remote contact through user-friendly tools.

Indexed as

Clinical Trials as TopicHealth PersonnelRare DiseasesRespiratory Tract DiseasesAdultAgedFemaleHumansMaleMiddle AgedPatient-Centered CarePatient ParticipationSurveys and QuestionnairesDecentralized clinical trialDirect-to-patient deliveryPatient-centricPatient perspectiveQualitative studyRare diseaseRespiratory disease

Identifiers

PMID40540194
PMCPMC12579702

What OpenQuestion holds

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LicenceCC BY
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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.