You are a cancer patient and your doctor suggested a clinical trial you could join, or you are searching one yourself? But what are the risks of an experimental study? The Anticancer Fund receives a lot of questions from people with cancer about clinical trials through My Cancer Navigator, our personalised information service for people with cancer. Most of them are willing to try new treatment options, as they are aiming for a better outcome. But it seems like there are still quite some misconceptions about clinical trials. Some of them can be easily demystified.

What are clinical trials?

Research on a new cancer treatment starts in the lab, where scientists try to understand its effect first on cancer cells, followed by experimental animal models. This gives them a good prediction on which treatments to test safely in humans. Needless to say, humans are more complex and the effects seen in the lab, do not always translate to sick people.  

When a new treatment is tested in patients, a stepwise approach is being taken. In a first phase, or in a phase I study, the focus is to find out if the new treatment is safe and to explore the best way to give the treatment. In the next phase, a phase II study, it is time to assess if the treatment actually works. Finally, a phase III study will test if the new treatment is better than the standard treatment. In this stage, the aim should be to evaluate if the new treatment can extend the patient’s life and/or improve the quality of life.

Why should I participate? Or not?

There are definitely some good reasons to join a clinical study. When you take part in a trial, you contribute to research. Scientists and doctors will gain better knowledge about cancer and in this way, you will help improve cancer care. Trials are the only way to make progress against cancer.  

Moreover, your health will be followed very closely when you participate in a trial. The procedures in the protocol will ensure not only that the new treatment can be properly studied, they should also guarantee that the best possible care is given. If you are enrolled in a randomised study and do not receive the new treatment being tested, you will at least get the best known standard treatment. This might be as good as the new one.

When there’s no good standard treatment available for your condition, being offered an experimental treatment at least gives you a chance to try a potentially effective treatment where not many options are left.  

Of course, there are also some drawbacks when considering participation: experimental treatments studied in a trial don’t always turn out to be better than standard care. Also, when you participate in a trial of a very promising new treatment, you might end up being assigned to the comparator, meaning you will not get the promising treatment but another drug, which might be a disappointment. In addition, even if you receive a potentially effective treatment, there is no guarantee that it will work for you. And finally, despite all the precautions taken before the start of a study, the new treatment may have side effects that were not expected.  

Guinea pig or lucky dog?

A perception of clinical trials might be that they are risky, and that participants are ‘guinea pigs’, left at the mercy of researchers. This is a myth since all clinical research studies have to go through very strict ethical and regulatory checks before they get a green light to start. These checks also ensure that clinical trial participants receive investigational drugs only after that drug has gone through extensive testing. And, it is important to know that a treatment consisting of only placebo is rarely used in cancer trials.

Some key points when joining an experimental study: before starting a trial, you could enquire if you can continue to take the treatment after the trial ends and the treatment was working for you. In a trial with a comparator, you are sometimes allowed to switch over to the experimental group if your cancer gets worse, so this is worth checking as well.

Once you have started in a clinical trial, there might be several reasons to stop the therapy, for instance:

• The treatment, or the trial, is completed.

• You have too many side effects and it is no longer safe for you to continue taking the treatment.

• The treatment does not work for you, and you need a different treatment.

• You decide to no longer participate in the trial.

This last point is important: you have the right to withdraw your consent at any time, for any reason, and your doctor(s) will continue to take care of you.

What does a clinical study cost?

Participation in a clinical study should normally not create an extra financial burden on patients.

Standard care costs are usually covered by the health insurance. The research costs, related to taking part in the trial should be covered by the trial’s sponsor. This can include costs for extra visits to assess the safety of the new treatment, for the studied medication and for extra lab tests and imaging tests to better evaluate the effects of the new treatment.

However, when you take part in a clinical trial, you may have extra visits to the clinic that you would not have with standard treatment. These extra visits can add costs for transportation, housing, food, and child care.

The situation might be different if you decide to take part in a clinical trial in another country. The healthcare system there will be different from your country and it depends how your health insurance will deal with that. Before enrolling in a study abroad it is important to clarify this. Also travel and lodging costs might contribute to the total financial burden of a clinical trial abroad.

How do I know if a trial is right for me?

Whether you have been asked to participate in a specific clinical trial or are wondering yourself whether joining a clinical trial might be a valid option, My Cancer Navigator, the personalised service for cancer patients of the Anticancer Fund, can help. We can provide you with more information on the trial that has been proposed or find out if there are trials that might be suitable for you, which you can then discuss with your doctor.

Once you decide to participate in a trial, you will have to go through the so called ‘informed consent process’. This informed consent is documented by means of a written, signed and dated form. Please, take your time and always carefully read the information that is provided to you before you sign the consent form.

How does the informed consent process work? For a start, your doctor and study nurse will explain the trial to you. They will give you all the details about the purpose of the trial, the practical aspects, such as the visits, the procedures and the tests, and also inform you about the potential risks and benefits. Make sure you understand this properly and don’t be afraid to ask questions. Also make sure you learn about your (other) treatment options if you would decide not to participate.

It might not always be easy for you to speak up, but be assured that you have the right to receive clear information to enable you to voluntarily decide whether or not to participate in a trial. And, as said, we can support you in this. Do not hesitate to contact My Cancer Navigator when in doubt.