What Is 'Standard of Care' in a Trial?

Standard of care is the treatment that doctors widely accept and use for a specific cancer. In a clinical trial, standard of care is often the comparison treatment: the option researchers measure a new treatment against, to see if the new one is actually better.

Placebos, treatments with no real drug at all, are rarely used in cancer treatment trials. It would not be ethical to withhold effective, proven treatment just to test something new. Instead, most trials give one group the current standard of care, and another group a new treatment, or the standard of care plus something new added on. This way, everyone in the trial gets real, effective treatment.

If you join a trial with a standard-of-care comparison group, and you get randomly assigned to that group, you are not being denied treatment. You are getting the same treatment you would likely get outside the trial anyway, often with closer monitoring than usual. Some people are disappointed not to get the newer option. It helps to remember that standard of care exists because it already works. It is not a consolation prize.

What counts as standard of care today may not have been standard five or ten years ago. Many of today's standard treatments were once the "new" arm in a past clinical trial. This is exactly how cancer treatment keeps improving: a new treatment gets tested against the standard, and if it wins, it can eventually become the new standard itself.

Standard of care is not always one single option. For many cancers, several different approaches are all considered acceptable standard of care, depending on your specific situation. Ask your oncologist directly what the standard of care is for your exact diagnosis, and how a trial option compares with it, including the pros and cons of each.

Picture a trial that adds a new drug on top of standard chemotherapy. It compares that against standard chemotherapy alone. Say you join, and get randomly assigned to the standard-of-care group. You still get full, effective chemotherapy. It is the same treatment you would get outside the trial. You are part of the comparison group. Your results help show whether the new drug actually helps. Both groups in a well-designed trial like this get real, active treatment.

Some rare cancers have no single standard of care. The same is true for cancers that stop responding to usual treatments. In that case, a clinical trial can be a reasonable path forward. It is not just a last resort. Ask your oncologist directly whether a standard treatment still exists for you. Ask whether trial options deserve serious consideration in your case.

Two respected cancer centers can sometimes have slightly different views on standard of care for the same cancer, especially in areas where evidence is still evolving. This does not mean one hospital is wrong. It means there is legitimate room for judgment. A second opinion can help you understand the range of reasonable standard approaches, not just one center's version of it.

Ask what the current standard of care is for your specific cancer. Ask how a trial's new treatment compares with that standard, based on results so far. Ask what you would receive if you are randomized to the standard-of-care group in a trial. Ask how quickly standard of care might change in your specific cancer type.

• FDA — Patient-Friendly Language for Cancer Clinical Trials.
• National Cancer Institute — How Clinical Trials Work.