Assuming you are in the US, the FDA regulates all clinical trials. http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm http://www.fda.gov/ForPatients/

Assuming you are in the US, the FDA regulates all clinical trials. http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm It might be quite difficult for you to run a clinical trial. There are likely more opportunities in the systems that surround clinical trials (patient education, patient/doctor communications, training). If you don't have a background in biostatistics, start learning. Biostatistics is the interface between the FDA and the clinical trial team.