How do we make sure a trial is safe?
Independent scientific review
Reviewing trial protocols
All trials conducted at the MRC Clinical Trials Unit at UCL are reviewed before the trial can start. The plan for the trial (called the protocol) is sent to a number of scientists for comment. The protocol is also reviewed by patients, or their representatives. Importantly, both patients and researchers who review the trial plan must be independent of the trial.
Ethics committees
Making sure the planned research is ethical and as safe as possible
All of our trials have to be reviewed and approved by an ethics committee before they can start. This makes sure the planned research is ethical and as safe as possible. Ethics committees usually include members of the public, researchers and health care professionals.
Once the trial is running, any changes that are made to the trial protocol also have to be examined and approved by the ethics committee. Researchers must also tell the ethics committee if people experience unexpected and serious side effects during the trial.
Data monitoring committees
Looking at how the trial is progressing
Most trials have a data monitoring committee that looks at how the trial is progressing. The people on the data monitoring committee must be independent of the trial. The committee has a number of important roles. It ensures that the trial is safe by studying information about any harms or side effects of the treatments being used in the trial. It also looks at the interim or early results of a trial and decides if a clear result has been reached about which treatment is better, or decides that it is very unlikely that the new treatment will be better than the current standard. Based on its independent assessment of all this information, the data monitoring committee can recommend whether a trial should continue or not.
National and international guidelines
Guidelines for properly run trials
There are guidelines to ensure that trials are run properly. European Law agreed in 2004 means that all organisations that run trials must ensure there are arrangements in place in case people are harmed during a trial of a drug. You can read more on this in the guidelines from the Department of Health on Good Clinical Practice (GCP) in non-commercial trials.
The Research Governance Framework developed by the Department of Health sets out standards of good practice in the conduct of health research. Ethics committees check these arrangements are in place when they make decisions about whether to agree that a trial can go ahead.
Informed consent
Explaining the trial, and getting agreement to take part
Before a participant joins a trial, the researcher must explain the trial and get the person’s agreement to take part. The researcher must explain:
- The aim of the trial – why is it taking place?
- The treatments that are being compared
- What the trial involves for participants
- Possible benefits and risks involved
All participants should receive a patient information sheet explaining these things.
Participants are usually asked to sign a form giving informed consent to take part in a trial. Informed consent means that participants have been given the important facts about a trial, understand them and have decided to take part in the trial of their own free will.
For children, a parent or guardian has to give consent for them to take part in a trial. Older children should also understand and agree themselves.
Participants can change their mind after signing the informed consent form, and can withdraw from a trial at any stage.
Confidentiality
Keep information secure and confidential
Confidentiality of patient data is very important in clinical trials. In a trial, all medical records are confidential. This information is kept securely, and only a very limited number of people have access to it. Participants’ names, or details that could help others identify individual participants, are not used in any reports about the trial. Trials run by the MRC Clinical Trials Unit at UCL all comply with the EU General Data Protection Regulation .