How do I know it’s safe?

Experimental drugs have been thoroughly tested in laboratory trials before they are ever tested with groups of humans. Then, experimental drugs must get through human trials at phase 1 and 2 before they can be used in phase 3 trials. Clinical trials are research; they aim to answer a question regarding an experimental drug.

There are many other safeguards for people taking part in trials:

  • The trial plan (protocol) is inspected and must be approved by an ethics committee.
  • The running of the trial is supervised by a data monitoring committee during the trial.
  • Your privacy is protected.
  • You must be told all about the benefits and risks before you agree to take part.

For more information, go to: http://www.fda.gov/cder/handbook/develop.htm.