Evidence map›Paper›PMID 32340974›Full record

ArticleJournal of medical Internet research2020

Data Validation and Verification Using Blockchain in a Clinical Trial for Breast Cancer: Regulatory Sandbox.

Tomonobu Hirano, Tomomitsu Motohashi, Kosuke Okumura, Kentaro Takajo, Taiyo Kuroki, Daisuke Ichikawa, Yutaka Matsuoka, Eisuke Ochi, Taro Ueno

Abstract read
In one paragraph

Article in Journal of medical Internet research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
–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

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Applications of Blockchain in the Medical Field: Narrative Review.Journal of medical Internet research · 2021
    Pooled it
  2. Trial
  3. Article
  4. Review
  5. Enhancing randomized clinical trials with digital twins.NPJ systems biology and applications · 2025
    Review
  6. Enhancing Cancer Care through Blockchain Technology.Asian Pacific journal of cancer prevention : APJCP · 2025
    Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Review
  14. Article
  15. Review
  16. Review
  17. Article
  18. Article
  19. Is blockchain ready for orthopaedics? A systematic review.Journal of clinical orthopaedics and trauma · 2021
    Review
  20. 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

9 authors.

Tomonobu HiranoSUSMED Inc, Tokyo, Japan.ORCID 0000-0002-6702-0925
Tomomitsu MotohashiSUSMED Inc, Tokyo, Japan.ORCID 0000-0002-5197-4927
Kosuke OkumuraSUSMED Inc, Tokyo, Japan.ORCID 0000-0002-9473-9257
Kentaro TakajoSUSMED Inc, Tokyo, Japan.ORCID 0000-0001-6373-5678
Taiyo KurokiSUSMED Inc, Tokyo, Japan.ORCID 0000-0002-9593-1574
Daisuke IchikawaSUSMED Inc, Tokyo, Japan.ORCID 0000-0002-1467-5119
Yutaka MatsuokaDivision of Health Care Research, Center for Public Health Sciences, National Cancer Center Japan, Tokyo, Japan.ORCID 0000-0002-8690-8129
Eisuke OchiDivision of Health Care Research, Center for Public Health Sciences, National Cancer Center Japan, Tokyo, Japan.ORCID 0000-0002-2497-0250
Taro UenoSUSMED Inc, Tokyo, Japan.ORCID 0000-0003-3697-4301

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe integrity of data in a clinical trial is essential, but the current data management process is too complex and highly labor-intensive. As a result, clinical trials are prone to consuming a lot of budget and time, and there is a risk for human-induced error and data falsification. Blockchain technology has the potential to address some of these challenges.

objectiveThe aim of the study was to validate a system that enables the security of medical data in a clinical trial using blockchain technology.

methodsWe have developed a blockchain-based data management system for clinical trials and tested the system through a clinical trial for breast cancer. The project was conducted to demonstrate clinical data management using blockchain technology under the regulatory sandbox enabled by the Japanese Cabinet Office.

resultsWe verified and validated the data in the clinical trial using the validation protocol and tested its resilience to data tampering. The robustness of the system was also proven by survival with zero downtime for clinical data registration during a Amazon Web Services disruption event in the Tokyo region on August 23, 2019.

conclusionsWe show that our system can improve clinical trial data management, enhance trust in the clinical research process, and ease regulator burden. The system will contribute to the sustainability of health care services through the optimization of cost for clinical trials.

Indexed as

BlockchainBreast NeoplasmsData AnalysisFemaleHumansReproducibility of Resultsblockchainbreast cancerclinical trialdata managementregulatory sandboxvalidation

Identifiers

PMID32340974
PMCPMC7298640

What OpenQuestion holds

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LicenceCC BY
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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 OpenQuestion graph.