Clinical Trials Take Place in Phases

For a treatment to become part of standard treatment, it must first go through 3 or 4 clinical trial phases. You do not have to take part in all phases. The early phases make sure the treatment is safe. Later phases show if it works better than the standard treatment.

What are the phases of clinical trials?

Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients.

Most clinical trials are classified into one of three phases:

  • Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
  • Phase II  trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.
  • Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide
  • In addition, after a treatment has been approved and is being marketed, the drug's maker may study it further in a phase IV trial. The purpose of phase IV trials is to evaluate the side effects, risks, and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials. Thousands of people are involved in a phase IV trial.
     
Purpose Number of People Who Take Part
Phase I
To find a safe dose
To decide how the new treatment should be given
To see how the new treatment affects the human body
15 to 30 people
Phase II  
To determine if the new treatment has an effect on a certain cancer
To see how the new treatment affects the human body
 
Phase III  
To compare the new treatment (or new use of a treatment) with the current standard treatment From 100 to thousands of people
Phase IV  
To further assess the long-term safety and effectiveness of a new treatment Several hundred to several thousand people

 

Source: The National Cancer Institute Reviewed 7/07 and 4/08