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 can come from

  • Laboratory work
  • Clinical experience with patients

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.

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. They point out any difficulties that the researchers might have overlooked. They also check how the results will be worked out (analysed). The protocol will often be reviewed by patients too.

After the protocol has passed the scientific review, the trial team need to find the money to run the trial.  We have more information about how trials are funded.

Once the trial team has funding they send it to an ethics committee who decides whether to approve it or not. We have more information about how trials are approved.

We also have information about

Last reviewed

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

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