Clinical Trials 101
Why Conduct Trials

Clinical trials are an important part of biomedical research, particularly the treatment process. During a clinical trial, patient volunteers participate in a structured scientific study. These studies are typically designed to assess the safety and efficacy of an experimental treatment option, or compare the efficacy of two treatment options. Participants are free to leave any study, at any time, for any reason.

Phase 1
Researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase 2
The experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

Phase 3
The experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

Phase 4
Studies done after the treatment has been marketed to gather additional information including the drug's risks, benefits, and optimal use.

Source: ClinicalTrials.gov

 

The U.S. Food and Drug Administrations (FDA) requires comprehensive clinical trials to determine if a new treatment option should be approved and made available. New treatments would not be developed or come to market without the invaluable participation of patient volunteers. The National Institutes of Health (NIH) maintains a comprehensive database to connect patients to active clinical trials that are relevant to their health needs.

Benefits of Participating
  • Access to new drugs and medical devices that may provide significant benefit and that may not be approved by the FDA for many years.
  • Receive the new treatment free of charge and may otherwise be compensated for participation.
  • Trials often take place in the country’s leading healthcare facilities and are often coordinated by leading medical experts in a particular area.
Importance of Participating
  • Help the entire FGIMD community by advancing scientific understanding and making it possible for new treatment options to come to market.
  • Participants get the opportunity to take a proactive and empowering role in their healthcare.