What are Clinical Trials?

Clinical trials (also called interventional studies) are a type of medical research involving human volunteers.1 They seek to evaluate a medical, surgical, or behavioral intervention and help researchers to determine if a new treatment is safe, more effective, and/or has less harmful side effects than existing standard treatments.2 Clinical trials are regulated by the US Food and Drug Administration, which performs inspections of sites where these studies occur to protect study participants and to verify the quality and integrity of the data being gathered.3 Clinical trials are conducted in four phases and are used to:4, 5

  • Determine if a new drug or device is safe effective
  • Find the appropriate dosage for a drug
  • Explore different ways to use standard or current, approved treatments
  • Study side effects
  • Learn how to safely use a treatment in a population not previously tested for that treatment.

Footnotes

1. US National Library of Medicine (2019 March). Learn about Clinical Studies. https://clinicaltrials.gov/ct2/about-studies/learn#WhatIs

2. National Institute on Aging (2020, April 9). What are Clinical Trials and Studies? https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies

3. US Food and Drug Administration (2014, September 12). Basics about Clinical Trials. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials#

4. National Institute on Aging (2020, April 9). What are Clinical Trials and Studies? https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies

5. US Food and Drug Administration (2014, September 12). Basics about Clinical Trials. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials#