Things to consider before taking part in a trial

People with CF have shared many positives to being involved in trials. By taking part in a trial you could: 

• understand your condition better
• take a more active role in your healthcare 
• help researchers to develop new treatments for future generations
• receive treatments that are not yet widely available 
• benefit from more regular appointments and discussions during the trial
• benefit from regular follow up meetings 
• help others with cystic fibrosis

I really only have positive things to say about being part of trials. It feels good to take control and trials gave me the opportunity to be proactive. If we want better treatments, we need to participate in that process.

– Stuart

Read people’s stories of taking part in trials

Taking part in a trial is likely to involve additional visits and monitoring. For some trials you may have to travel to a different centre. There’s always the possibility of side effects. It’s important to fully understand what to expect during a trial.

It is also important to know that you might not take a new treatment. You may take a standard treatment or a placebo. This still contributes to the trial by helping identify the best treatment for yourself and others. Find out about different types of trial.

You should never feel pressured to take part in a trial. You can take as much time as you need to decide whether or not to take part. You may also find it useful to talk with your family and friends about any possible impact on your personal life, as well as work, school and family commitments.

Taking part in one clinical trial can sometimes affect whether you can take part in other trials. Some trials have a follow-up period, where you will continue to be monitored for some time after the treatment period ends. You may not be able to take part in another trial during this period. 

Genetic therapy trials might have longer follow-up periods than usual. This could mean that taking part in one genetic therapy trial means you might not be able to take part in another genetic therapy trial that you might be suitable for if it comes up. 

While it’s not always possible to know what other trial opportunities will become available in the future, make sure you find out what other trials are in set up or recruiting before making a decision. You can find these on the Trials Tracker. You can also talk to your CF team about how taking part in a particular trial could affect your eligibility for future trials and to get an idea of the types of trials that are likely to be coming down the pipeline. 

Ask the trial team as many questions as you need to fully understand the trial. For example:

1. What are the potential risks and benefits? 
2. Has the treatment been given to people with CF before and, if so, what were the results?
3. Will some of the people on the trial be given a placebo or a standard treatment? Will I be told if I am in the treatment group or the control group?
4. Will I be paid to take part? Will my expenses, like travel and refreshments be paid?
5. How long is the trial? How many visits will there be and are any virtual? Will I have to take time off work or school?
6. Who should I speak to if I have a question or concern? 
7. How long will I be expected to participate? What kind of follow up will there be?
8. Will taking part in this trial affect whether I can take part in other trials? 
9. If the treatment helps me, will I be able to continue on it after the trial ends?
10. Who will tell me what the results of the trial are, and how long after the trial has ended?

The trial team are responsible for making sure that you are fully informed about the trial at all times. This is called informed consent.

Informed consent is a process to make sure that you:

• can ask questions and get answers before, during and after the trial
• fully understand the purpose of the trial
• fully understand what the trial will involve
• are informed about potential benefits to health, risks and inconveniences
• willingly agree to take part 
• understand you can stop taking part at any point, without needing to give a reason
• remain informed throughout and given any new information about the trial.

You can’t be entered into a trial without giving your written consent by signing a consent form. You should keep your own copy of this.