What is a Clinical Trial?

A clinical trial is a research study to answer specific questions about vaccines, therapies or new ways of using known treatments. Clinical trials are the next step after research in the lab produces promising results.

What is a Protocol?

All clinical trials are based on a set of rules called a protocol. A protocol describes what types of people may participate in the trials, the schedule of tests, procedures, medications and dosages and length of the study. While in a clinical trial, participants are regularly monitored by the research staff to determine the safety and effectiveness of their treatment.

What are clinical trial phases?

There are four phases associated with a clinical trial.

• Phase I involves testing in 20 - 80 people to evaluate the drug's safety and determine a safe dosage range and identify side effects.
  
• In Phase II, the drug or treatment is tested on 200-300 people to see if it is effective and to further evaluate its safety.
  
• In Phase III, the study drug or treatment is given to a larger group, 1000 - 3000 people, to confirm its effectiveness, monitor side effects and collect information that will allow the treatment to be used safely.
  
• Phase IV studies are done after the drug or treatment has been approved by the Food and Drug Administration (FDA) and made available for public use. Studies continue to test the new drug or treatment to collect information on their effect in various populations and any side effects associated with long-term use.

What is a placebo?

A placebo is an inactive pill, liquid or powder that has no effect on the human body. In clinical trials, experimental treatments often are compared with placebos to assess the treatment's effectiveness.

What is Informed Consent?

Informed consent is the process of learning the key facts about the clinical trial before a person decides whether or not to participate. These facts include:

• Why the research is being done
  
• What the researchers want to accomplish
  
• What will be done during the trial and for how long
  
• What risks are involved in the trial
  
• What benefits can be expected from the trial
  
• What other treatments are available
  
• That the participant has the right to leave the trial at any time.