What are clinical studies?

  • Clinical studies allow us to investigate the potential of medicine. They do this by testing on volunteers, but only after the investigational drug in question has gone through extensive testing in the laboratory.
  • All medications must be tested in clinical studies (also known as clinical research studies) before they are approved and available for use.
  • Without people willing to volunteer their time for medical research, it would be almost impossible to evaluate potential new treatments for medical conditions, and potentially few medical advances would be made. Most clinical studies use a placebo to test the investigational drug.

What is a placebo?

A placebo is something that looks exactly like the investigational drug, and is delivered in exactly the same way, but does not contain any active drug. Placebos help scientists to see whether any changes are due to the investigational drug in question, or some other factor.

What are the phases of clinical research studies?

Phase One

  • 20–80 participants
  • Studies the initial safety of an investigational drug
  • Participants in Phase 1 studies are usually healthy volunteers

Phase One

Note: This information is about clinical trials in general—it is not specific to TANGO. The safety of participants is always the first priority of any clinical study.

What being in a clinical study means

  • Your health may be monitored more closely while you are on the study than it would normally.
  • You may receive the investigational drug or you may receive a placebo.
  • There is no guaranteed impact on the disease if you receive the investigational drug. It may make it better, worse, or the same as before. There may also be no benefit from participating in a clinical study.
  • You may provide valuable information that might help improve medical research and knowledge. This could benefit you, and others like you, in the future.
  • You may experience unwanted side effects (these are listed in full in the Informed Consent Form, although we can never predict them all).