Clinical Trials Terminology

• Standard of care

A routine approach (medicine or procedure) recommended to patients who have a certain disease and who share the same or similar circumstances. Standard of care is accepted by medical experts as being an appropriate clinical approach that is widely applied by a prudent and qualified healthcare professional. For certain conditions, the standard of care may be no treatment or observation (as in smouldering myeloma). Standard of care can also be referred to as best practice, standard medical care or standard therapy.

• Placebo

A harmless and inactive pill (sometimes referred to as a “sugar pill”) or injection that is designed to look like the drug being tested in some clinical trials. This is done to account for a “placebo effect,” which is a perceived psychological effect that does not reflect the efficacy of the actual drug. In general, it is unethical to receive no treatment or a placebo on its own in studies that treat cancer. At the very least, participants are given the approved standard of care treatment with or without the placebo.

• Arms

The specific treatment groups of clinical trials.

- Experimental arm: Receives the treatment being studied
- Control arm: Receives the standard of care alone or with placebo

• Randomized controlled trial

In trials with more than one arm, participants are randomly assigned to a group (arm) receiving a particular treatment, either the treatment being studied (experimental arm) or the standard of care (control arm).

• Cross-over option

If a participant receiving the standard of care treatment is no longer responding to the treatment, some trials provide the option to “cross-over” to the experimental arm and receive the treatment being studied. Note: Not all studies allow for cross-over; this will be told to you at the beginning of the study, or you can ask your doctor or nurse before you sign an informed consent form.

• Open label and blinded (or "masked") studies

In open label studies, both the research team and the participants are aware of the drug or treatment the participants are receiving. In contrast, participants in single-blinded studies do not know which treatment(s) they are receiving. In double-blinded studies, both the participants and all members of the research team do not know which treatment(s) the participants are receiving.

Blinded studies are designed to prevent members of the research team or study participants from unintentionally influencing the results. They are designed to produce data that are not influenced by bias or expectations from the participants or researchers, thus allowing for scientifically accurate conclusions of the actual benefits and side effects (adverse events) of the treatment being studied.