The U.S. Food and Drug Administration must approve a pharmaceutical company's proposal for a clinical trial.
Companies research a drug's safety and efficacy for years before they begin testing on humans.
The Institutional Review Board is a group of healthcare professionals who review and authorize every clinical study before commencement. Their primary responsibility is to protect the safety and rights of study participants. All medications, both FDA-approved and investigational, can have side effects. Everyone responds differently to a particular medication. For example, aspirin causes stomach upset in some people.