Evidence map›Paper›PMID 40890902›Full record

ArticleBritish journal of clinical pharmacology2026

Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitus.

Julia Kopanz, Amy Rogers, Lina Pérez-Breva, Emily Hall, Prashasthi Devaiah, Isla S Mackenzie, Bart Lagerwaard, Diederick E Grobbee, Mira G P Zuidgeest, Trials@Home consortium

Abstract read
In one paragraph

Article in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

10 authors.

Julia KopanzJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.ORCID https://orcid.org/0000-0003-4082-0807
Amy RogersMEMO Research, Division of Cardiovascular Research, University of Dundee, Dundee, UK.ORCID https://orcid.org/0000-0001-5207-7032
Lina Pérez-BrevaVaccine Research. Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)-Public Health, Valencia, Spain.
Emily HallMEMO Research, Division of Cardiovascular Research, University of Dundee, Dundee, UK.
Prashasthi DevaiahMEMO Research, Division of Cardiovascular Research, University of Dundee, Dundee, UK.
Isla S MackenzieMEMO Research, Division of Cardiovascular Research, University of Dundee, Dundee, UK.ORCID https://orcid.org/0000-0002-3680-7127
Bart LagerwaardJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
Diederick E GrobbeeJulius 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.
Trials@Home consortiumtrialsathome.com.

Funding

Innovative Medicines Initiative 2 Joint Undertaking 831458
6 · The paper itself

Abstract

aimsThe aim of this study was to determine the purpose and use of physical examination (PE) in phase 3 and 4 drug interventional clinical trials within type 2 diabetes mellitus.

methodsA total of 226 clinical trial protocols identified from the ClinicalTrials.gov database were systematically reviewed by five researchers. Data on trial and PE characteristics were extracted, including frequency and timing, purpose, elements and conduct of PE.

resultsA total of 211 protocols (59% phase 3, 72% two-arm trials) were reviewed. Of these, 190 protocols mentioned a PE, and by distinguishing between different types of PE, a total of 241 PEs were assessed. Of the 190 protocols, 65% of protocols explicitly documented the purpose(s) for conducting a PE. PE was most often explicitly documented to identify adverse events (40%), followed by assessment of trial endpoints (33%), eligibility (21%), overall health status (3%) and characterization of the study population (1%). Sixty per cent of PEs described what was to be examined, and 8% specified how the PE should be conducted.

conclusionsProtocols often lacked information on the purpose, elements and conduct of the PE, which may negatively impact the consistency of clinical trials. With the purpose of PE being often not explicitly stated, it can be questioned whether a PE is needed in every clinical trial or if it is performed as a matter of routine. Future research is needed to investigate whether PE is always necessary in a clinical trial and to explore opportunities for PE in clinical trial innovations including decentralization.

Indexed as

Clinical Trials as TopicClinical Trials, Phase III as TopicClinical Trials, Phase IV as TopicDiabetes Mellitus, Type 2Hypoglycemic AgentsPhysical ExaminationHumansResearch DesignHypoglycemic Agentsclinical skillclinical trialclinical trial innovationclinical trial protocolphysical examination

Identifiers

PMID40890902
PMCPMC12746396

What OpenQuestion holds

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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.