First-in-Human Studies: IND or CTA

Small to midsize pharmaceutical and biotechnology companies whose development efforts advance to the point of contemplating first-in-human (FIH) clinical trials frequently face a challenging decision: File a clinical trial application (CTA) with the intent of conducting FIH trials in a European Union (EU) member state and under the regulatory eye of the respective regulatory agencies and European Medicines Agency (EMA), file an investigational new drug (IND) application with the US Food and Drug Administration (FDA) with the intent of conducting FIH trials in the US under the umbrella of FDA regulations, or conduct clinical research in other regulatory jurisdictions that have unique corporate and operational advantages.