I think you are really confusing yourself and need to go away for a bit to understand how studies are conducted in the USA. You can't just conduct any clinical trial in the USA without meeting extensive criteria.
The below link will assist you with understanding the general requirements of conducting clinical trials in the USA. Look at the section which details the rules to make a study applicable for clinical trials. Such rules are designed to ensure the quality of trial in the USA before registration.
https://clinicaltrials.gov/ct2/manage-recs/faq
nti - in preparation of full results release, page-55
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