Clinical trials adhere to stringent international regulations, as outlined by the ICH-GCP (International Conference on Harmonization, Good Clinical Practice) recommendations, the Declaration of Helsinki adopted by the General Assembly of the World Medical Association in June 1964, the Nuremberg Code of 1947, and other applicable regulations and guidelines.
These trials can be conducted in a single center or across multiple centers in different cities and countries. Most clinical trials involving patient volunteers are multicenter and are concurrently conducted in countries such as the European Union, the United States, Canada, Japan, etc.
The USA leads in the number of conducted clinical trials per capita, followed by the countries of the European Union.
Initiating a clinical trial in the USA is contingent upon receiving approval from the FDA (Food and Drug Administration) and the IRB (Institutional Review Board). Per FDA regulations, an IRB is a formally designated group responsible for reviewing and monitoring biomedical research involving human subjects. According to FDA regulations, an IRB possesses the authority to approve, require modifications in (to secure approval), or disapprove research. This group review plays a vital role in safeguarding the rights and welfare of human research subjects.
For more information, you can visit the FDA website:
The Good Clinical Trial Practice Guidelines establish internationally recognized ethical, scientific, and quality standards for the design, conduct, documentation, and reporting of trials involving volunteer participants.
These guidelines ensure:
