Suzanne Cole, M.D. Answers Questions On: Clinical Trials in Oncology

Clinical trials are studies in which the most common way of treating cancer is compared against a new treatment. Sometimes the new treatment is given to participants instead of the most common cancer treatment, and sometimes the new treatment is given in addition to the most common cancer treatment. The ultimate goal is to prove scientifically whether newer treatments are better than the old cancer treatments. 

Clinical trials are especially important when it comes to a life-and-death situation such as cancer. Physicians and scientists need to prove that their new treatments actually are better than what is already out there. Sometimes we find out during the clinical trial that the older treatment is better than the new treatment because the new treatment did not work as well as we thought it would. Sometimes we find out during the clinical trial that the newer treatment is better than the old way of doing things, and then the newer treatment gets approved by the FDA to become the new way we treat all patients with cancer.

Because cancer can be so deadly, sometimes clinical trials are “treatment-only” trials, where everyone on the clinical trial is given the new drug as treatment for the cancer. No one is placed in a placebo group, or given a sugar pill, and everyone gets the same treatment that we hope will help their cancers shrink, allowing the patient to live longer. It is very rare for a cancer clinical trial to have a treatment versus a placebo, and if a patient is ever offered enrollment in a clinical trial with a placebo, then the patient will clearly be told what is happening and whether getting a placebo is possible.

There are risks associated with participating in a clinical trial. Because some drugs used in clinical trials are new, we might not know all of the side effects that could happen. Although drugs are tested in animals and small numbers of humans, when a new drug is tested in more people, a new side effect might be discovered. There is also the risk that the new drug might not work as well as we would like. The risks have to be weighed against the benefits of trying something, when all other options have failed and with the hope that the clinical trial drug will benefit the patient by controlling the cancer and helping the patient live longer.

Our clinic generally treats cancer with chemotherapy and immunotherapy, so most of our treatments involve oral medications or pills, or infusions of chemotherapy or immunotherapy. We occasionally combine these treatments with cancer surgeries or radiation therapy.

People with cancer who agree to take part in a clinical trial receive benefits themselves while also helping to move the science forward for other patients who will be diagnosed with cancer and require treatment.

Patients who participate in clinical trials will often have the chance to receive the latest breakthrough treatments years before these treatments become available to the general public. Patients who participate in clinical trials also tend to receive closer follow-up with extra nursing support, often with more frequent lab evaluation or body imaging, such as CT scans, PET scans, or MRIs, which give researchers an up-to-date sense of whether the therapy is working.

I’ve had patients who took great comfort in knowing that their participation in a clinical trial could help to change the course of cancer treatment for everyone. When faced with a callous and life-threatening disease that turns your life upside down, it is nice to know that you are helping future cancer patients by paving the way for the treatments we’ll be using to treat cancer tomorrow.