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

Aims The 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.Methods A total of 226 clinical trial protocols identified from the ClinicalTrials.gov database were systematically review...

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Autores: Kopanz, J, Rogers, A, Pérez-Breva, L, Hall, E, Devaiah, P, Mackenzie, IS, Lagerwaard, B, Grobbee, DE, Zuidgeest, MGP
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2026
País:España
Institución:Universidad de Málaga
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:dnet:r-fisabio___::55c9e825f53ecc02dee9e9a22c854a97
Acceso en línea:https://fisabio.portalinvestigacion.com/publicaciones/20457
Access Level:acceso abierto
Palabra clave:clinical skill
clinical trial
clinical trial innovation
clinical trial protocol
physical examination
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spelling Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitusKopanz, JRogers, APérez-Breva, LHall, EDevaiah, PMackenzie, ISLagerwaard, BGrobbee, DEZuidgeest, MGPclinical skillclinical trialclinical trial innovationclinical trial protocolphysical examinationAims The 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.Methods A 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.Results A 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.Conclusions Protocols 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.WILEY2026info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/20457BRITISH JOURNAL OF CLINICAL PHARMACOLOGYISSN: 03065251ISSNe: 13652125reponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Universidad de MálagaInglésinfo:eu-repo/semantics/openAccessoai:dnet:r-fisabio___::55c9e825f53ecc02dee9e9a22c854a972026-06-11T12:45:17Z
dc.title.none.fl_str_mv Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitus
title Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitus
spellingShingle Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitus
Kopanz, J
clinical skill
clinical trial
clinical trial innovation
clinical trial protocol
physical examination
title_short Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitus
title_full Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitus
title_fullStr Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitus
title_full_unstemmed Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitus
title_sort Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitus
dc.creator.none.fl_str_mv Kopanz, J
Rogers, A
Pérez-Breva, L
Hall, E
Devaiah, P
Mackenzie, IS
Lagerwaard, B
Grobbee, DE
Zuidgeest, MGP
author Kopanz, J
author_facet Kopanz, J
Rogers, A
Pérez-Breva, L
Hall, E
Devaiah, P
Mackenzie, IS
Lagerwaard, B
Grobbee, DE
Zuidgeest, MGP
author_role author
author2 Rogers, A
Pérez-Breva, L
Hall, E
Devaiah, P
Mackenzie, IS
Lagerwaard, B
Grobbee, DE
Zuidgeest, MGP
author2_role author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv clinical skill
clinical trial
clinical trial innovation
clinical trial protocol
physical examination
topic clinical skill
clinical trial
clinical trial innovation
clinical trial protocol
physical examination
description Aims The 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.Methods A 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.Results A 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.Conclusions Protocols 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.
publishDate 2026
dc.date.none.fl_str_mv 2026
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://fisabio.portalinvestigacion.com/publicaciones/20457
url https://fisabio.portalinvestigacion.com/publicaciones/20457
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv WILEY
publisher.none.fl_str_mv WILEY
dc.source.none.fl_str_mv BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
ISSN: 03065251
ISSNe: 13652125
reponame:r-FISABIO. Repositorio Institucional de Producción Científica
instname:Universidad de Málaga
instname_str Universidad de Málaga
reponame_str r-FISABIO. Repositorio Institucional de Producción Científica
collection r-FISABIO. Repositorio Institucional de Producción Científica
repository.name.fl_str_mv
repository.mail.fl_str_mv
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