What Are Clinical Trials?

 

What Are Clinical Trials?

 

It's important to be aware of any unexplained changes to your body, such as the sudden appearance of a lump, blood in your urine, or a change to your usual bowel habits.

 
  • Treat cancer
  • Find and diagnose cancer
  • Prevent cancer
  • Manage symptoms of cancer and side effects from its treatment

Phases of Clinical Trials

 

Clinical trials to test new cancer treatments involve a series of steps, called phases. If a new treatment is successful in one phase, it will proceed to further testing in the next phase. During the early phases (phases 1 and 2), researchers figure out whether a new treatment is safe, what its side effects are, and the best dose of the new treatment. They also make sure that the treatment has some benefit, such as slowing tumor growth. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid.

 

The following shows the number of patients that take part and the purpose of the most common phases. Although the trial phases are explained in the context of drug treatment trials, the same concepts apply to most types of clinical trials.

 

Phase 1

 

Purpose:

  • To find a safe dose
  • To decide how the new treatment should be given (by mouth, in a vein, etc.)
  • To see how the new treatment affects the human body and fights cancer

Phase 2

 

Purpose:

  • To determine if the new treatment has an effect on a certain cancer
  • To see how the new treatment affects the body and fights cancer

Phase 3

 

Purpose:

  • To compare the new treatment (or new use of a treatment) with the current standard treatment