Evidence map›Paper›PMID 34148219›Full record

ReviewDrugs - real world outcomes2021

Current Status, Challenges, and Future Perspectives of Real-World Data and Real-World Evidence in Japan.

Katsutoshi Hiramatsu, Annabel Barrett, Yasuhiko Miyata, PhRMA Japan Medical Affairs Committee Working Group 1

Abstract readReview
In one paragraph

Review in Drugs - real world outcomes, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing 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

38 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Effect of Early-Onset Dementia on Job Loss in Japan: A Matched Cohort Database Study Using Health Insurance Claims Data.Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society · 2026
    Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Risk of Urogenital Bacterial Infection with Sodium-Glucose Cotransporter-2 Inhibitors: A Retrospective Cohort Study Using a Claims Database.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024
    Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Early-onset dementia and risk of hip fracture and major osteoporotic fractures.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024
    Article
  19. Article
  20. The emerging role of real-world data in oncology care in Japan.ESMO real world data and digital oncology · 2023
    Review
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

4 authors.

Katsutoshi HiramatsuAmgen K.K., Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo, 107-6239, Japan. khiramat@amgen.com.ORCID http://orcid.org/0000-0002-0746-7557
Annabel BarrettEli Lilly and Company Limited, Berkshire, UK.
Yasuhiko MiyataBristol Myers Squibb K.K., Tokyo, Japan.
PhRMA Japan Medical Affairs Committee Working Group 1

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this article is to help develop a common understanding of the current status, challenges, and future perspectives of real-world data (RWD) and real-world evidence (RWE) in Japan. RWD and RWE are very widely used terms, but standardized definitions are lacking. Given broad and growing applications of RWD/RWE from the perspective of clinical development and medical affairs, the PhRMA Japan Medical Affairs Committee Working Group 1 have proposed the following definitions: "RWD are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources" and "RWE is the evidence derived from analysis of RWD." The key challenges for RWD and RWE in Japan include restricted access and linkage of RWD, as well as a lack of universally accepted methodological approaches, which reduces the potential for patient and healthcare benefits. These challenges for RWD/RWE are by no means unique to Japan and similar challenges exist for countries in Europe and the USA. The quality of data and analysis, study design, and the transparency of reporting should be discussed more to ensure credibility and acceptance by decision-makers as the demand for RWD and RWE increases. The future developments around Japan's RWD and RWE are expected to include improved RWD access, data linkage, and increased acceptance by decision-makers, all supported by innovative technology. Improvements in RWD access and database linkage will enable both public and private sectors to assemble more comprehensive health information in Japan.

Identifiers

PMID34148219
PMCPMC8605941

What OpenQuestion holds

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Registered trials

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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.