FAQs
Your informed consent is required before being enrolled in a trial. By giving consent, you affirm that you have been provided with all relevant information needed for you to make the decision to participate in the trial, such as information about the study design, how you will participate, your right to leave at any time, study alternatives, and the associated risks and benefits of the trial. Informed consent is designed to protect patient safety.
Standard of care is a treatment that is already approved for use outside of clinical trials and is available for a specific health condition. Potential new treatments in a clinical trial are still being tested to study their safety and/or efficacy.
To ensure that the data is accurate and not biased, comparisons are performed among study groups. Each participant is randomly assigned to one of the various groups (i.e., the potential new treatment being studied or existing approved treatments).
Some clinical trials are designed to be blinded, which means that the participant and sometimes the researchers are unaware of which study group/treatment participants are assigned to. This is used to reduce the effect of bias on study data.
In some trials, researchers must compare the effects of a potential new treatment on participants to those who do not receive the potential new treatment being studied. They are called the control or control group.