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Published on: January 16, 2019
[Specified Clinical Research]
1Division of Gastroenterology and Hepatology, Dept. of Internal Medicine, Keio University School of Medicine.
The Clinical Trials Act (2017) was enacted to ensure research integrity after major frauds. Despite initial challenges, specified clinical research is increasing, highlighting the Act's benefits for transparent and safe drug development.
Area of Science:
- Clinical research ethics
- Pharmaceutical regulation
- Medical law
Context:
- Research frauds involving pharmaceutical clinical trials (2013-2014) led to the Clinical Trials Act.
- The Act mandates compliance with research standards, contract disclosure, and certified review boards.
- Initial implementation faced challenges including researcher unfamiliarity and procedural complexities.
Purpose:
- To promote high-quality, transparent, and safe clinical research.
- To restore public confidence in pharmaceutical research and development.
- To ensure academic and social significance in clinical studies.
Summary:
- The Clinical Trials Act (2017) was established in response to significant research misconduct.
- It requires adherence to standards, disclosure of funding, and certified review boards for quality assurance.
- Post-implementation, specified clinical research is growing due to guidance and improved operational understanding.
Impact:
- Increased confidence and transparency in clinical research.
- Facilitation of high-quality drug development and medical innovation.
- Establishment of a robust framework for ethical and reliable clinical trials.
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