FAQs

Your ”informed consent” is required before being enrolled in a trial. This means you have been provided all relevant information about the study design, how you will participate, your right to leave at any time, study alternatives, and the associated risks and benefits. Informed consent is designed to protect patient safety.

"Standard of care" is treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals. Also called best practice, standard medical care, and standard therapy.

Interventional studies test new treatments that are not yet approved by regulators, while observational studies evaluate approved treatments by tracking participant health outcomes over time. In interventional studies, participants are often assigned randomly to different groups with different treatments for comparison. In observational studies participants are not assigned a treatment, it is already part of their healthcare regimen. (Most references to clinical trials on this site refer primarily to interventional studies.)

To ensure quality data and no bias when comparisons need to be made between study groups, each participant is randomly assigned to the different groups (i.e., experimental intervention, standard intervention, or placebo).

A placebo is an inactive version of an intervention that is not intended to provide any medical benefit. It Is designed to look the same to the study participant and study team. The placebo is used as comparison to confirm any effects of the intervention being studied, if no approved intervention is available.

A "blinded" study is a study in which only the subject does not know what treatment he/she is receiving in a clinical study. Some clinical trials are designed to be “double blind” so both participants and researchers are unaware of which study group participants are assigned to. This prevents bias from affecting study data.

Researchers must compare the effects of a new intervention on participants to those who do not receive the intervention. They are called the “control” or “control group,” and may receive either a placebo or standard of care.