ArticleBMC medical ethics2026
What did trial participants in REMAP-CAP Japan experience during the COVID-19 pandemic? A qualitative study.
Article in BMC medical ethics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
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.
Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
backgroundInformed consent is crucial for clinical trial participation. However, there have been no qualitative studies of participants’ experiences in randomized control trials of acute and critical care, particularly during the COVID-19 pandemic, when clinical trials were significant public health measures. This study aimed to explore the experiences of critically ill patients in Japan who participated in an international clinical trial for COVID-19 therapeutics.
methodsA qualitative research method using conventional content analysis was employed. Data were collected through semi-structured interviews of participants in the anticoagulation domain of the Randomized, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP). All participants had been hospitalized in a Japanese ICU due to severe COVID-19, been deemed competent, and given prospective informed consent to participate.
resultsTen trial participants were recruited, and data saturation was achieved. Three categories emerged: (1) trial participation without awareness or adequate understanding, (2) interpretation of trial participation experience with reference to personal circumstances, and (3) emotions and thoughts evoked by trial participation. Details of the trials or interventions were poorly understood. Some participants were unaware they had consented to participate. While some expressed interest in future trials, others remained uncertain about their trial participation.
conclusionsCritically ill trial patients struggled to understand trial details during the informed consent process. Future research should optimize this process and ongoing patient support to balance autonomy and public health needs in health emergencies.
trial registrationNot applicable.
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Registered trials
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.