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.
