Challenges in Japanese Large-Scale Clinical Trials for Cardiovascular Diseases
Author Information
Author(s): Sawata Hiroshi, Ueshima Kenji, Tsutani Kiichiro
Primary Institution: The University of Tokyo
Hypothesis
What are the current funding and infrastructural challenges surrounding large-scale clinical trials in Japan?
Conclusion
To improve the quality of clinical trials, all sponsors should register trials and disclose funding sources before participant enrollment and publish results after study completion.
Supporting Evidence
- 72.4% of the trials were randomized controlled trials.
- 9.2% of the trials examined more than 10,000 participants.
- Ischemic heart disease was the most common target disease.
Takeaway
This study looked at big medical trials in Japan about heart diseases and found that many trials are not published, which can be a problem for understanding how well treatments work.
Methodology
The study examined clinical trials with 300 or more participants using various medical databases and registries at three different times.
Potential Biases
Industry-funded studies may be biased towards positive findings.
Limitations
Some trials did not disclose their designs or results, and the funding sources were often unclear.
Digital Object Identifier (DOI)
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