Safety in clinical trials
This page tells you about how you are protected when you take part in a clinical trial. There is information about
Safeguards in trials
Treatments are thoroughly tested in laboratory trials before they are ever tested with groups of patients. Then, treatments must get through testing with patients in phase 1 and 2 trials before they can be used in phase 3 trials.
There are many other safeguards for patients taking part in trials
- The trial plan (protocol) is inspected and must be approved by an ethics committee
- A data monitoring committee supervises the running of the trial
- Insurance must have been arranged for patients
- Your privacy is protected
- You must be told all about the benefits and risks before you agree to take part
Indemnity cover (insurance) pays compensation to you if any harm should come to you because of the trial. Under UK and European regulations, there has to be insurance or indemnity to cover people taking part in trials. The organisation or drug company funding the trial has to take out insurance. If they don't, the ethics committee may not approve the trial.
In practice, several different bodies may provide cover for you.
The NHS is liable for any clinical negligence if you have treatment in an NHS hospital or clinic as part of a trial.
University negligence insurance provides insurance for university researchers if any harm results from the design of a trial.
Drug companies are responsible for insuring against any harm caused by the drugs being investigated.
Testing licensed drugs
If a trial is testing drugs already licensed for treating cancer, there may not be extra insurance to cover use of the drug. The drugs have already been tested and found safe to use, so extra insurance is not thought necessary.
You would usually be covered by the insurance held by the doctor and hospital treating you. You can ask your doctor or research nurse about trial insurance if you are worried.
The researchers and organisations funding and running trials don't want any harm to come to the people taking part. They want better treatment for people with cancer.