British journal of clinical pharmacology · 2025
Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitus.
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Kopanz Julia, Rogers Amy, Pérez-Breva Lina, Hall Emily, Devaiah Prashasthi, Mackenzie Isla S, Lagerwaard Bart, Grobbee Diederick E, Zuidgeest Mira G P, Trials@Home consortium
Аннотация
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.
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.