Clinical Trial

Clinical trials are research studies that are performed to evaluate the safety and efficacy of a medical, surgical, or behavioral intervention, or diagnostic method. The intervention is generally compared with the current standard of treatment for the condition being studied.

Trials are carefully designed and must gain approval from the appropriate agencies. Most clinical trials involving living human subjects must be approved of by an Independent Review Board (IRB) to ensure risks are minimized and justified by anticipated benefits, subjects are selected and treated fairly, and informed consent is adequate.

Clinical trials used in drug development must first undergo approval by the U.S. Food and Drug Administration (FDA) based on preclinical/discovery data obtained through laboratory and animal studies. After initial approval the clinical trial undergoes four phases (I-IV) of investigation.

Source: Learn About Clinical Studies – (n.d.). Clinicaltrials.Gov. Retrieved January 8, 2022, from