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 larger phase 3 trials.
There are many other safeguards for patients taking part in trials.
The team running the trial must:
- make sure the trial plan (protocol) is reviewed by other doctors and approved by an ethics committee
- arrange a data monitoring committee (DMC) who will review the trial at regular intervals and can stop or modify the trial if they need to
- make sure they have insurance in place in case they need to pay compensation for any reason
- protect your privacy at all times
- tell you all about the benefits and risks before you agree to take part
Compensation for people taking part in trials
The indemnity cover (insurance) pays compensation to you if you are harmed because of the trial. Under UK and European regulations, 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
- universities provide 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
It is slightly different if you are taking part in a phase 4 trial
for a drug that is already licensed for treating cancer.
There may not be specific extra insurance to cover use of the drug. It would have already been tested and found safe to use, so extra insurance is not 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.