ReviewClinical and translational science2026
Six-Year Trends in Real-World Data Use for Post-Marketing Surveillance of New Medical Products in Japan.
Review in Clinical and translational science, 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.
- Six-Year Trends in Real-World Data Use for Post-Marketing Surveillance of New Medical Products in Japan.Clinical and translational science · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The Ministerial Ordinance on Good Post-Marketing Study Practice for Drugs was amended by the Ministry of Health, Labour and Welfare (MHLW) in 2018 to clearly define post-marketing database studies (DBS) as a measure of pharmacovigilance activities for approved medical products in Japan. This review describes and characterizes DBS in the landscape of post-marketing safety/effectiveness investigations of approved medical products in Japan for the past 6 years. New drugs and regenerative medical products approved by MHLW between January 1, 2019, and December 31, 2024, were included (N = 697). Of the total 572 planned post-marketing surveillances, 91 (15.9%) DBS were identified. The percentage of DBS initially decreased from 2019 to 2021 and then increased to 18.9% by 2024. Compared with other drugs, DBS were less likely planned for orphan (10.5%) and pediatric (7.4%) drugs. Control arms were used in 71.4% of DBS. The safety specifications evaluated in DBS using administrative data tended to focus on specific types of conditions, such as those related to the circulatory system. The findings suggest that DBS has begun to increase in recent years while highlighting challenges in accessing fit-for-purpose data and the need for appropriate pharmacoepidemiologic methods to support comparative evaluations. Access to large sample sizes provides DBS several advantages, including utility for evaluation of rare adverse events and the ability to establish a control group. Multi-sector and multi-stakeholder efforts may have the potential to further advance the utilization of real-world data in post-marketing benefit/risk investigations of medical products.
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Registered trials
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