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.

Find out how trials are funded.

Approving a  trial

Once the trial team has funding they send it to an ethics committee who decides whether to approve it or not.

Read about how trials are approved.

Related information

Last reviewed

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

Find a trial

Rate this page:

Currently rated: 2.6 out of 5 based on 28 votes
Thank you!
We've recently made some changes to the site, tell us what you think