Evidence map›Paper›PMID 40557473›Full record

ArticleBMJ open2025

Principal investigators' experience of COVID-19 therapeutic clinical trials in Japan: a qualitative study.

Satoko Horii, Hiroki Saito, Taro Shibata, Miwa Sonoda, Tatsuo Iiyama, Kazuaki Jindai

Abstract read
In one paragraph

Article in BMJ open, 2025. 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

6 authors.

Satoko Horii *School of Tropical Medicine and Global Health, Nagasaki University, Nagasaki, Japan.ORCID http://orcid.org/0000-0002-8459-1498
Hiroki Saito *Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada.ORCID http://orcid.org/0000-0002-6477-8204
Taro ShibataBiostatistics Division, Center for Research Administration and Support, National Cancer Center, Chuo-ku, Tokyo, Japan.ORCID http://orcid.org/0009-0008-3031-6117
Miwa SonodaDepartment of International Trials, National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan.ORCID http://orcid.org/0000-0002-3729-9275
Tatsuo IiyamaDepartment of International Trials, National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan.ORCID http://orcid.org/0000-0002-5244-3458
Kazuaki JindaiDepartment of Virology, Tohoku University, Sendai, Miyagi, Japan jindai.kazuaki.z15@kyoto-u.jp.ORCID http://orcid.org/0000-0003-4679-3862

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveDuring the COVID-19 pandemic, many clinical trials were conducted to identify effective COVID-19 therapeutics. However, while a large amount of resources was invested and significant numbers of patients participated, this did not necessarily have an impact on clinical practice. To face these issues, initiatives such as the 100 Days Mission have been set out globally. Yet, limited data exist on the context surrounding the implementation of clinical trials at a national level during a health emergency. The study explored experiences and perceptions of principal investigators in conducting clinical trials for COVID-19 therapeutics in Japan.

designA qualitative study was conducted using semistructured interviews. The obtained data were inductively analysed using thematic analysis. SETTING AND

participantsWe interviewed 15 principal investigators between September and November 2022 who conducted investigator-initiated clinical trials on the development of COVID-19 therapeutics in Japan.

resultsThree themes were generated:

conclusionsThis study illustrated that the efforts of Japanese principal investigators did not necessarily pay off in identifying therapeutics. A strategic and systematic approach for an improved national clinical trial ecosystem must be sought during the interpandemic period to overcome structural barriers in harmonisation with the global stakeholders.

Indexed as

Clinical Trials as TopicCOVID-19COVID-19 Drug TreatmentResearch PersonnelHumansInterviews as TopicJapanQualitative ResearchSARS-CoV-2Clinical TrialCOVID-19Health policyINFECTIOUS DISEASESPublic healthQUALITATIVE RESEARCH

Identifiers

PMID40557473
PMCPMC12198784

What Socratic holds

Textmetadata
LicenceCC BY-NC
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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 Socratic graph.