How clinical trials are set up

When the trial protocol is ready it is given to a research ethics committee for approval. The research ethics committee is an independent group of people that includes doctors, nurses, medical staff, members of the public and sometimes lawyers. They decide whether the trial is ethical. In particular, they check that:

• the trial is looking at an important question in cancer care that can’t be answered using previous or current research
• researchers are qualified to carry out the trial
• the protocol is suitable for the needs of the trial
• the probable benefits of a new treatment are likely to outweigh the side effects
• there is enough information for patients to decide whether they want to go into the trial
• the way in which people will be entered into the trial (recruited  ) is correct
• there will be compensation for people in the trial in the unlikely event that something goes wrong
• the local health services have the resources to carry out the trial
• extra travel expenses will be offered to people taking part
• the hospital research and development process has all the facilities to support the research.

When the ethics committee has approved the trial it can begin.

The doctor or nurse who asks you to take part in a clinical trial may not be the person who designed and set up the study, especially if it is a study with patients in different hospitals. But they will have detailed information about the study. Your doctor or nurse can give you all the information you need, or let you know where to get it. Your cancer specialist and GP are still the people in charge of your care, making the day-to-day decisions with you about your treatment.

All trials involving people have to be designed, carried out and reported on according to international good practice guidelines. The guidelines are in place to protect the rights and safety of people taking part in clinical trials, and make sure that the results of the trials are accurate.

In the UK, the Medicines and Healthcare Products Regulatory Agency is responsible for making sure that all trials follow the guidelines and are registered on an international database. Any serious side effects during trials are also recorded on the international database.