Hello! I am not a clinical trial expert (though I often lean on wonderful colleagues who are!) but if we got to that stage with our materials (after rigorous tests in a laboratory environment) the clinical trials would test for both safety and efficacy. The design of what representative population group to test on would be the job of the trial design expert. It would also depend on whether we have designed a material that targets a specific disease or whether it's designed to repair injuries (blunt force trauma).

I would also add that different countries have slightly different pathways to design clinical trials. So what's FDA approved may not necessarily be EMA approved (European equivalent).