How are trials organised?

How are Clinical Trials Organised?

Clinical trials are carefully organised studies that test new treatments, tests, procedures or ways of treating diseases like ovarian cancer. Getting a trial up and running can be a complex and long process. Before any patient is given a new treatment or test it has to go through a series of steps to ensure that the trial is ethical and as safe as possible (Table A).

First, doctors or researchers have an idea they believe needs testing. This may involve:

• Trying a new treatment alone or in combination with an already established treatment (e.g. a new immunotherapy drug combined with a current chemotherapy drug, or including an exercise program to help reduce side effects from treatment).

• Combining existing treatments in a new way (e.g. testing the combination of a well-known chemotherapy drug, like paclitaxel, with a targeted therapy, such as bevacizumab, to see if this combination works better than using each treatment alone).

• Using an already established treatment for a new condition (e.g. using a certain chemotherapy drug that was previously only used in breast cancer for another type of cancer, or monitoring early-stage disease by nurse-led follow-up).

Once the idea is established, the research team need to write a ‘trial protocol’. The protocol explains:

• why the trial is being done

• who can join (eligibility criteria)

• what treatments will be used (e.g. chemotherapy, radiation, immunotherapy, exercise programs)

• the tests, appointments and anything else the patient will have.

Before the trial can start, the protocol has to be checked by a team of research experts who ensure that everything about the trial is:

• safe

• practical

• necessary.

Trials require funding. Funding may can come from:

• a charity

• the government

• a pharmaceutical company.

After funding is secured for the trial, it then has to be reviewed by an ethics committee to ensure that the trial is in the best interest of patients. If the ethics committee approves the trial, cancer centres and hospitals with the right resources can ask to join the trial and begin recruiting patients who are eligible.

Those who are eligible will be given all the details about the trial study, which will include any potential risks and benefits.

If you are eligible and decide to join a trial, you will be given a consent form to sign. If it is a randomised trial, you will most likely be randomly assigned to one of two or more groups to ensure the trial is fair.

Once the trial is over (the timeframe of trials vary), the research team will analyse the data to find out if the new treatment gives better results than the current standard treatments for that type of cancer. The results are then published and shared with other health professionals to ensure everyone has access to the best treatment options.

Your medical team will continue to follow you up for a period of time after your treatment finishes.

Table A: Steps in a Clinical Trial