How clinical trials are planned and organised
This page is about where ideas for trials come from and how researchers then plan trials.
Ideas for trials
Ideas for trials can come from
- Laboratory work
- Clinical experience with patients
Planning a trial
Once a group of researchers have an idea, they need to develop a protocol. This is a detailed plan for the trial. It includes
- Why the trial should be done
- Numbers of patients they need to recruit
- Who should be able to take part in the trial (eligibility)
- Details of the treatments to be given
- What tests the patients will have and when
- Details about how, when and what information (data) will be collected
Everyone involved in the trial has to use the protocol. That makes sure all the patients taking part are treated in the same way.
Checking the protocol
The researchers usually send the protocol for 'independent scientific review' or 'peer review'. This means that people with the right experience and qualifications look through the protocol to make sure it is all correct.
The reviewers point out any difficulties that the researchers might have overlooked. They also check how the results will be worked out (analysed).
The protocol is often reviewed by patients too.
Getting money for the trial
After the protocol has passed the scientific review, the trial team needs to find the money to run the trial.
Approving a trial
Once the trial team has funding they send it to an ethics committee who decides whether to approve it or not.