November 15, 2023
You may have heard of clinical studies, but you might not know much about them. Each medicine doctors give their patients must first be approved by a regulatory agency, such as the U.S. Food and Drug Administration (FDA) and similar agencies in other countries. Before this can happen, we need real-world evidence that a medicine is safe and that it is effective in the populations with disease. Sponsors (pharma and biotech companies) run clinical studies to gather the evidence and submit it to regulatory agencies who review the evidence and approve the medicine for patients, if it is safe and effective.