Evidence map›Paper›PMID 35488483›Full record

ArticleClinical pharmacology and therapeutics2022

Opportunities and Challenges for Decentralized Clinical Trials: European Regulators' Perspective.

Amos J de Jong, Tessa I van Rijssel, Mira G P Zuidgeest, Ghislaine J M W van Thiel, Scott Askin, Jaime Fons-Martínez, Tim De Smedt, Anthonius de Boer, Yared Santa-Ana-Tellez, Helga Gardarsdottir and 1 more

Open access · hybridAbstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 4 pooled it
19.2field-weighted citation impact, top 1% 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

67 citing papers in PubMed, 4 syntheses or guidelines pooled it, 110 citations in OpenAlex.

  1. Pooled it
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  16. The potential of artificial intelligence in clinical trials.European journal of clinical investigation · 2026
    Review
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  18. Article
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  20. Article

7 more citing papers are in PubMed but not listed here.

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

11 authors at 6 institutions in 5 countries.

Amos J de JongDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.ORCID 0000-0002-6860-9213
Tessa I van RijsselJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Mira G P ZuidgeestJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Ghislaine J M W van ThielJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Scott AskinRegulatory Affairs Innovation, Novartis Pharma AG, Basel, Switzerland.
Jaime Fons-MartínezThe Foundation for the Promotion of Health and Biomedical Research of Valencia Region, Valencia, Spain.
Tim De SmedtGlobal Regulatory Affairs, UCB Pharma, Brussels, Belgium.
Anthonius de BoerDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Yared Santa-Ana-TellezDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Helga GardarsdottirDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Trials@Home Consortium
University Medical Center Utrecht · NLUtrecht University · NLFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · ESNovartis (Switzerland) · CHUCB Pharma (Belgium) · BEUniversity of Iceland · IS

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Decentralized clinical trials (DCTs) have the potential to improve accessibility, diversity, and retention in clinical trials by moving trial activities to participants' homes and local surroundings. In this study, we conducted semi-structured interviews with 20 European regulators to identify regulatory challenges and opportunities for the implementation of DCTs in the European Union. The key opportunities for DCTs that were recognized by regulators include a reduced participation burden, which could facilitate the participation of underserved patients. In addition, regulators indicated that data collected in DCTs are expected to be more representative of the real world. Key challenges recognized by regulators for DCTs include concerns regarding investigator oversight and participants' safety when physical examinations and face-to-face contact are limited. To facilitate future learning, hybrid clinical trials with both on-site and decentralized elements are proposed by the respondents.

Indexed as

Research PersonnelHumans

Identifiers

PMID35488483
PMCPMC9540149
OpenAlexW4225117080

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.