How Trials Are Set Up
Clinical trials are designed by doctors and other specialists with input from a wide variety of people, increasingly including patients. They start with a systematic review of previous trials and their results to see what is already known. A systematic review provides more accurate answers than individual trials and helps to identify important questions that still need to be answered through further research.
Doctors, nurses, patients, and researchers collaborate with statisticians, trial managers, and representatives from pharmaceutical companies, if relevant, to design the best possible trial. The design for the trial forms the basis of the trial protocol.
When the trial protocol is ready it is sent to a research ethics committee - an independent group of people that includes doctors, nurses, other medical staff, members of the public, and sometimes lawyers. They decide whether the trial is ethical. In particular they check whether
the potential benefits of a new treatment are likely to outweigh the side effects,
the information provided to help people decide whether they want to participate in a trial is clear and satisfactory,
the way in which people will be asked to take part in a trial (recruited) is appropriate,
there will be compensation for people in the trial in the unlikely event that something goes wrong, and
travel expenses will be offered to people who take part.
The trial can only go ahead when it has been approved by an ethics committee.