Overview
The UMIN case data repository system was implemented by adding a function to the UMIN Clinical Trials Registry System.
The aim of this system is to keep anonymized case data from clinical research conducted by individual researchers at the UMIN center,
and to guarantee the content of the data to third parties. This system enables other researchers to inspect case data or to repeat statistical analyses.
Thus, it is expected to facilitate the following:
- Checking whether clinical research data have been fabricated or falsified
- Preventing statistical analysis results unfavorable to the researcher (including the funding agency) from being concealed
Features
- To prevent fraud in clinical research, the system provides a case data repository available to all researchers who have a UMIN ID.
- The backup and security systems of the UMIN guarantee the long-term storage of data.
- Download of the data is not available to the public, but is limited to an individual (i.e. with a UMIN ID) specified by the researcher.
important point
◇Notes for researchers
Make sure that data are anonymized. Do not upload any personal information including medical record numbers.
A record of the data update history will be maintained.
Once uploaded to the case data repository system, the data (i.e. documents relating to the research plan and case data specification, and the case data) cannot be deleted, although they can be overwritten.
◇Notes for those who download data
You can download data only using the UMIN ID for which the researcher has given permission.
At the time you download data, your UMIN ID, name, and affiliation are notified to the researcher.
Operating manual
Using case data repositories
Use case data repositories for trial information registered in the UMIN Clinical Trials Registry System (UMIN-CTR).
Confirmation and update of data registered in the case data repository system.
Registered in another clinical trial registry.
New use of individual case data repositories only.
List of all publicly available clinical trials registered with UMIN CTR/ICDR
Background
Frauds in clinical research
Recently, there has been growing social concern, both in Japan and abroad, about the fabrication and falsification of clinical research data as well as disclosure of the methods
and results of statistical analysis. Thus, the urgent development of strategies to prevent such frauds in clinical research has been called for.
Otherwise, clinical research conducted in Japan and clinical research papers submitted by Japanese researchers may lose international credibility.
As a consequence, the Association of National University Hospital Directors has issued an "urgent plan to ensure the credibility of
clinical research and to manage conflicts of interest," and the Commission of Clinical Research on Hypertension Treatment Drugs of the Ministry of Health,
Labour and Welfare has issued "response and preventive strategies to the case of clinical trials on hypertension treatment drugs: interim report.
" The latter pointed out, as one of the related background problems, that "it was difficult to verify the credibility of the data because most of the related
research materials had already been discarded" and proposed "making it obligatory to keep related materials of the clinical research" as a possible preventive strategy.
Issues that cannot be resolved by clinical trial registration
Clinical trial registration has played a significant role in preventing fraud in clinical research. However, registration alone is not capable of preventing fraud
if the data themselves have been fabricated or falsified, or statistical analysis results unfavorable to the researcher (including the funding agency) are not published
(especially for outcomes other than the primary outcome). This is partly because there has been no official system for third parties to access raw case data from clinical research.
There are other case data repositories in the world, but they are limited in scope. The US Food and Drug Administration has developed a case data repository for clinical trials conducted by
pharmaceutical companies, and the National Institutes of Health has developed a case data repository for clinical trials funded by the NIH. However,
as far as we know, our system is the first case data repository available to any researchers in the world.
The UMIN case data repository
The UMIN case data repository system is expected to help prevent frauds in clinical research by;
- keeping the original case data of clinical research for cross-checking and inspection
- making the case data available for statistical analysis that is not reported in publications
- providing the case data for a minimal level of quality check.
However, it should be noted that clinical trial registration and case data repository alone cannot assure the quality of the clinical research data,
nor eliminate frauds in clinical research completely.
It is essential to implement various strategies proposed in "urgent plan to ensure the credibility of clinical research and to manage conflicts of
interest" by the Association of National University Hospital Directors and "response and preventive strategies to the case of clinical trials on hypertension treatment drugs:
interim report" by the Commission of Clinical Research on Hypertension Treatment Drugs of the Ministry of Health, Labour and Welfare, and to conduct inspections to cross-check the data
in medical records.
Contact
Enquiries should be sent using the contact form. FAQs should be referred to before sending an enquiry.
- For those involved in clinical trials (researchers and pharmaceutical companies) who agree to the above notes;
Proceed
(UMIN-ICDR) Individual Case Data Repository
For trials registered in the UMIN clinical trial registration system (UMIN-CTR), you can access the registered trial from the [Updating your registered trial information] button.
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