The Question: I have run out of conventional medical treatments for my cancer, which has metastasized. How do I join a clinical trial? How do I increase my chances of receiving the drug rather than taking a sugar pill?
The Answer: For this question – a common one here at Sunnybrook’s Odette Cancer Centre – I went to Scott Berry, who in addition to being a medical oncologist is also a bioethicist.
“As an oncologist, we have made great advances in improving outcomes for people with cancer but we need to do better. The best way of doing this is to study new treatments so we put a high priority on offering our patients the chance to take part in a clinical trial,” Dr. Berry said in an interview in the cancer center, the second largest in Canada.
Currently there are more than 650 clinical trials taking place across Canada for all different forms of cancers.
Trials aren’t always for patients who have run out of conventional treatments. And most are not placebo controlled so the worries over a sugar pill are few. Most trials today compare a new treatment to a current one.
More broadly, a trial is an intervention that can be a drug, surgery, device, radiation, diet or even an exercise program. The results can be compared to a new medical approach, a standard one already available or a placebo. It can even be compared to nothing at all. The purpose is medical knowledge.
For some patients who have exhausted other conventional therapies, a clinical trial can be seen as a lifesaver. Doctors always try to give patients the full picture: that as much as this may lengthen their lives or reduce their symptoms, it doesn’t work in every patient every time.
“We have to balance this hope and encourage people. But we have to remind them that although we hope that people getting the new treatment will do better, in some cases, they could do worse,” said Dr. Berry. “And unless we do this type of study we will never know for sure.”
Indeed, a dozen years ago, there was little oncologists could provide to patients whose colorectal cancer had spread. Back then patients faced an average life expectancy of one year. Now, there are five new drugs available and many patients live twice as long.
Clinical trials can last months or years as researchers try to determine the safety of a given intervention and, whether it helps, harms or is no different than what is currently provided. Certain outcomes are measured in patients, often to the current available treatment.
A significant issue for patients and clinicians is informed consent, said Dr. Berry, who is also a bioethicist.
“We tell them why we are doing the trial, the background information, but we do not promise too much,” he said.
“I think the thing is we hope things will be better but we really don’t know that.”
Some patients want to sign up right away after hearing details, going over the risks with the oncologists or nurses, but Dr. Berry always tells them to sleep on it. Most come back, wanting to discuss options.
“Some are uncomfortable with the randomness of it,” said Dr. Berry.
There are four phases to clinical trials, with phase 1 being the earliest, smallest – recruiting up to about 30 patients – and are often referred to as dosing or safety trials.
Phase 2 trials try to find out what types of cancer the drugs work for and to get a better idea of side effects.
If it works well, it goes onto Phase 3 trials, which are large trials [hundreds or thousands of patients recruited at many centres] that compare a new treatment with the standard one, different doses or ways of giving a standard treatment. These trials are randomized, which means that patients are put into two groups: one to get the new treatment and the other to get the standard or placebo [a sugar pill if there is no standard treatment. That type of study is the gold standard for establishing new treatments.
“We are very clear about the [treatment] goals,” he said. “There are enthusiastic people who want something done but they have to be willing to understand what the goals are.”
Even if a clinical trial is not available at this hospital, it could be elsewhere, such as other teaching or community hospitals.
Below are links to clinical trials across Canada.