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Getting Started with Clinical Trials

A clinical trial is a way to find out how well a drug or treatment works and what the possible side effects may be.  

Clinical trials may: 
  • Look at a new use for a well-known drug or treatment.
  • Compare 2 different but well-known treatments to see if one is better.
  • Study the side effects and safety of a new drug or treatment.
  • See if a new test helps doctors find and treat problems earlier.
     
Before you agree to join a clinical trial, you will meet with the study coordinator. They will talk with you about the risks and benefits of the trial and what to expect. This is part of the informed consent process. You will only be part of a clinical trial if you agree to join.

Clinical trial phases 
Clinical trial phases show how far along a trial is in the research process. The Food and Drug Administration (FDA) requires most new treatments to go through 3 phases of clinical trials to be approved:
  • Phase 1 trials – Is the treatment safe? When a Phase 1 trial shows good results, it will move to Phase 2.
  • Phase 2 trials – Does the treatment work? When a Phase 2 trial shows good results, it will move to Phase 3.
  • Phase 3 trials – Is the treatment better than the standard treatment? You may be randomly assigned to get either the new treatment or the current treatment. You and your doctor won't know which treatment you get. This makes sure treatments are compared fairly. When a Phase 3 trial shows good results, it is approved by the FDA. This means other patients can get the treatment without being in a clinical trial. 

Once a trial is closed, the researchers will write a report on the results of the study. Read patient-friendly study summaries of transplant-related clinical trials here

To learn more: