Placebos in Cancer Clinical Trials: What Patients Need to Know

Misconceptions about clinical trials come up often among the patients Dr. Miguel Gonzales-Velez treats.

"The most common misunderstanding that I see is that patients think that they are going to be treated as guinea pigs, or that they are not going to get the best treatments available," he said.

Trials are designed with patient safety in mind while helping researchers determine whether a new treatment is safe and effective. Some cancer trials do use a placebo, an inactive pill, but patients are generally not asked to give up an established treatment that is known to work.

"When the placebos are done, they are most of the time done in ways that we are able to understand if the medications really work, but the patients get potential access to the real medications after the clinical trial," Gonzales-Velez explained.

Placebos appear most often in phase 3 trials, the final stage of testing before a treatment can be approved, which compare a new therapy against the current standard of care. One group receives standard treatment plus a placebo, and another receives standard treatment plus the investigational therapy. That structure shows researchers whether the new therapy adds a benefit and what side effects come with it.

How cancer is treated has also changed over the past decade, Gonzales-Velez noted. Cancer is not one disease, and treatment is increasingly tailored to the specific cancer and to the characteristics of an individual patient. Depending on the diagnosis, options include chemotherapy, immunotherapy, targeted therapy, protein-based therapies and hormone therapy. Those approaches are also combined, or used at different points in a course of treatment, to improve how well they work.

For many cancers, patients now have three or four treatment approaches available rather than one, he concluded.

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