Clinical trials for cancer are crucial to improving patient care; they explore whether new treatments are safe and whether they can benefit patients in terms of extending their lives, improving their quality of life, or even offering a cure.
However, there are often a number of misconceptions about trials. “There’s a tendency for people to think that they’re being used as a guinea pig or that they’re offered a clinical trial as a last resort,” says Anne Croudass, lead research nurse at Cancer Research UK (CRUK).
“But this isn’t always the case. Offering patients trials is part of routine clinical practice, so there’s no need for patients to feel alarmed if their doctor suggests one. A huge number of trials are done with cancer patients who are going to live for a long time.”
CRUK Patient advocate Tara Millar took part in a clinical trial in 2015; she has now been cancer-free for two years. “There’s such stigma around clinical trials ... but with all the support I was given it didn’t feel like a risk at all,” she says. “I overcame my fears by learning more about the trial. I’m really glad of the results and happy I got to take part.”
Clinical trials range from phase one to phase three. Phase one trials are aimed at investigating the safety and possible side-effects of a new drug and test what dosage might be best. They can be relatively intense over a short period, often requiring patients to stay overnight in specialist centres where they’re closely monitored by a team of nurses. Phase two trials look to prove that the new treatment or test has a definite benefit for patients, as well as acting in the way that scientists expect, and phase three trials explore that further, attempting to prove that the treatment or test works better than existing approaches for that cancer.
(Not quite) on the radar
Many cancer patients have never considered the idea of a clinical trial when they first receive their diagnosis, but there are trials running regularly in hospitals all over the country, from small district hospitals to major institutions. They are typically offered to patients by oncologists as a form of treatment, but that doesn’t mean patients can’t – or shouldn’t – bring up the possibility.
When offered a trial, patients should be provided with written information, reviewed by an ethics committee, which summarises all they need to know. They will then have a minimum of 24 hours to read it, ask questions, and decide whether to take part. Trials experts say it’s crucial that patients and their families make sure they understand the nature of the study, and the level of commitment required.
“People need to know why the clinical trial is being done – research questions can range from looking at the safety of a drug to looking at the effects of administering two drugs in parallel instead of one by one,” says Prof Emma Hall, deputy director of the Clinical Trials and Statistics Unit at the Institute of Cancer Research, a Cancer Research UK-funded institution. “Trials might also be testing radiotherapy schedules or surgical techniques, or even different ways of monitoring and following up patients.
“It’s important for people to understand the nature of what they’re signing up to,” she says. “Patients should ask how many visits will be required to the hospital, as some trials can be more onerous for patients than others. Will they be required to fill in extra questionnaires – and how long will they take? How long will they be monitored after the treatment phase has finished, and what will that entail?”
Because much work has taken place to ensure trials are streamlined into normal treatment, patients typically won’t have to wait longer than usual to receive treatment, with many trials commencing within a week of the patient signing up. However, in the case of some trials, especially phase three trials, it’s important to remember that being accepted on to the trial may not necessarily guarantee you access to a brand new treatment.
For example, trials comparing a new drug to chemotherapy will require one group of patients to receive the new medication, and the second group to be treated with standard chemotherapy. While some patients in the second group may be disheartened at missing out on the new drug, experts say it’s important to bear several things in mind.
“There’s research that shows that participating in a trial has wider benefits for patients, outside of the treatment itself, in terms of being looked after,” Hall says. “You may have additional tests and scans that you wouldn’t normally have, you’ll have more opportunity to report side effects more regularly, because you’re being monitored more closely, and you may be asked more regularly about your quality of life, about what is bothering you, which can be a good thing.
“Clinical trials can also be a way for hospitals to introduce new techniques or technologies in a safe and controlled manner – thereby improving care for all patients; not just those in the clinical trial.”
Finding the right trial for you
One of the most difficult things for some patients to digest is being rejected from a clinical trial. However, this should not necessarily deter them from applying for further trials. Cancer Research UK’s online database lists over 2,000 trials (not all of them are active) and allows users to filter for criteria including disease, type, location and treatment – giving an indication of the scale of trials in the UK. As cancer treatment moves forward and becomes increasingly personalised, trials are becoming ever-more specific, meaning they require a detailed examination of your medical history and often various screening tests to check that you’re eligible to take part, so you may not find the right trial straight away.
“Cancer is such a genetically diverse disease,” Hall explains. “Determining whether [a patient] is eligible for a trial could require a genetic sample to be taken from them , to be sent away and analysed.”
Many patients ask when the results of the clinical trial will become available and when the new treatment will be integrated into mainstream treatment on the NHS. It’s important to realise that all trials are major projects that can take many years before there’s sufficient data – and confidence in the results – to warrant anyone thinking about changing standard practice.
In addition, even if a new treatment passes through all phases of a clinical trial, it then has to be accepted by the European and UK regulatory bodies, and in some cases the manufacturing process has to be developed – so it can take 15 years from the first laboratory tests to a treatment becoming available to patients on a wider scale. This is why the costs typically associated with getting a new treatment to market are so high.
“It is expensive to run clinical trials,” Croudass says, “but that’s because they need to be scientifically sound. You need to make sure you’re getting the necessary information to properly prove what you’re trying to prove – and they’re labour intensive because they need to be done safely and ethically.”
CRUK offers an extensive cancer clinical trial database that allows you to filter for criteria including disease, type, location and treatment
